Terms and conditions

General Terms and Conditions

Published: September 1st, 2025.

1. General application

(1) These General Terms and Conditions (“General Terms and Conditions“) apply to all contractual relationships between QUALIFYZE GMBH (Bockenheimer Anlage, 46, 60322 Frankfurt am Main, Germany) (“Qualifyze“) and Qualifyze’s client/s (“Client” or “Clients”) as well as potential clients and users registered on the Qualifyze Platform that wish to use the Market Intelligence, Supplier Intelligence or Supplier Directory features (“User” or “Users”). Qualifyze, Clients and Users are also referred to collectively as the “Parties” and each as a “Party“.

(2) These General Terms and Conditions apply exclusively. They become effective once the Client or User accepts them and first uses the Qualifyze Platform. Any supplementary or differing terms proposed by the Client or User shall only apply if Qualifyze expressly agrees in writing, with the signature of a legal representative. The same applies to any other terms and conditions described in offers, confirmation emails or other Client´s or User’s documents, no promises, agreements or covenants other than those contained in the Subscription Agreement or these General Terms and Conditions shall be binding upon the Parties, unless agreed in writing by Qualifyze with the signature of a legal representative.

(3) Qualifyze’s range of services is only intended for entrepreneurs, i.e. natural or legal persons or partnerships with legal capacity, who are acting in the exercise of their commercial or independent professional activity when concluding the contract (section 14 para. 1 German Civil Code (Bürgerliches Gesetzbuch, “BGB”)). The Client and User´s own terms of business shall not apply, even if we do not expressly object to their validity in individual cases.

(4) Contracts with Clients and these General Terms and Conditions are concluded exclusively in English.

2. Scope of services

(1) Qualifyze offers the following services:

(a) Qualifyze enables the Client to have suppliers (e.g. from the pharmaceutical, food, cosmetics, and feed sectors, etc.) audited to ensure that these suppliers meet the industry’s quality standards (the “Audit Services”). 

(b) Qualifyze grants its Clients and Users access to the Qualifyze Platform, Market Intelligence, Supplier Intelligence and Supplier Directory (the “Platform Services”) in the Qualifyze Platform. 

(2) Scope of Audit Services:

(a) In accordance with the respective Framework Subscription Agreement concluded between Qualifyze and the Client (“Subscription Agreement”), Qualifyze grants the Client access to the Qualifyze Platform with a service plan (“Service Plan“, cf. Annex 1) under the categories of STANDARD, and PREMIUM, respectively. Upon payment of the platform access fee, the Client obtains access to the Qualifyze Platform, and upon payment of the corresponding credit fee, credits are awarded (“Credit or Credits“) to be used for a certain number of audit reports each year of the contract (“Contract Year”) of the respective Subscription Agreement, in accordance with the Service Plan selected. 

(b) Qualifyze shall act as a third-party auditor on behalf of the Client either for: a) performing a new – shared or exclusive – audit (“New Audit“) of the Client’s suppliers (“Auditees“) and preparing a new audit report (“New Audit Report“) for the Client, the specific process of which is set out in Clause 5; or b) providing the Client with an existing audit report from an audit that was already performed (“Existing Audit Report“), the specific process of which is set out in Clause 6. 

(c) Qualifyze can share any New Audits that are not specifically requested and paid for by the Client as an “Exclusive Audit” (Exclusive Audits shall be specifically requested and paid for by the Client as such, in which case Qualifyze shall not be entitled to add the Audit Report to its database or resell it), with other Qualifyze Clients on the Qualifyze Platform. The Client acknowledges and agrees that, in certain cases, Auditees may only agree to be audited under an Exclusive Audit. In such instances, Qualifyze may require the Client to proceed with an Exclusive Audit. If the Client does not agree with this approach, the Audit will be cancelled and Qualifyze shall make the Credit available again to the Client. Qualifyze will not perform a New Audit if there is a valid Existing Audit Report available on Qualifyze’s Platform that meets the Client’s requirement and that has been performed three years before the Client’s request. A Shared Audit refers to the audit conducted by Qualifyze that is not specifically requested and paid for by a single Client as an Exclusive Audit. Instead, the audit may be conducted on behalf of multiple Qualifyze’s clients.

(d) The audits are conducted by independent, qualified, and experienced auditors in accordance with international quality standards (“Auditors“). Qualifyze ensures the quality, confidentiality, and lack of conflicts of interest of the Auditors. Qualifyze carefully selects its Auditors based on their professional qualifications, experience, and personal suitability. Qualifyze´s Auditors have:

  • successfully completed Qualifyze´s process of auditor qualification and continue to train regularly; and
  • signed a declaration of their personal independence, objectivity, and neutrality and of the confidential treatment of all information and documents obtained during an audit.

If an Auditor becomes unavailable immediately before, during or after an Exclusive or Shared Audit, Qualifyze will – provided that another Auditor is available and can be used without disproportionate additional expense – appoint another Auditor as substitute.

(e) Qualifyze´s audit reports shall contain a complete, accurate, concise, and clear record of the audit. Unless otherwise agreed, they shall include or refer at least to the following:

  • audit objectives;
  • scope of the audit, in particular, the naming of the Auditee and the processes examined;
  • name of the Auditor/s and the participants from the Auditee;
  • dates and, if applicable, the location where the audit was carried out;
  • audit criteria;
  • audit findings and related supporting evidence;
  • audit conclusions;
  • statement of the extent to which the audit criteria have been met; and
  • any unresolved differences of opinion between the Auditor and the Auditee.
  • Auditor CV. 
  • declaration of independence.

(f) The findings of Qualifyze´s audit reports are based on a sampling process aimed at obtaining the most reliable possible evidence of (non-)compliance with the audit criteria. In addition, there may be other business aspects that were not examined by Qualifyze´s Auditor and which may justify different conclusions. It is the sole responsibility of the Client to evaluate the conclusions of the audit report.

(g) If the audit report of an Exclusive or Shared Audit shows the necessity of corrective and/or preventive actions by the Auditee, Qualifyze undertakes to contact the Auditee after a specified period of time in order to obtain information on the status of these actions and to pass it onto the Client. Within the scope of a follow-up audit, Qualifyze will verify the completion of these measures and their effectiveness.

(3) Scope of Platform Services:

(a) Qualifyze grants Users and Clients access to Supplier Intelligence, Market Intelligence and Supplier Directory (the “Platform Services”) in the Qualifyze Platform. 

  • Through the Qualifyze Platform, Users will gain access to the Audit Reports and will be able to manage their Audit Reports easily and efficiently. 
  • Through the Market Intelligence tool, Users will be able to identify key insights in QA and supplier selection processes through the analysis of certain public or de-identified data of suppliers worldwide (“Suppliers”). For the avoidance of doubt, the data will in no case be linked to an identifiable supplier without the corresponding permission.
  • Through the Supplier Intelligence tool, Clients who have access to audit reports issued by Qualifyze will be able to view their audited suppliers (“Auditees”) in a centralized way, enabling them to analyze the level of compliance of each supplier based on Qualifyze´s quality criteria. Comparison between suppliers as well as global standards will also be available to identify outliers in supplier rating distributions.
  • Through the Supplier Directory tool, Users will be able to view a list of Suppliers worldwide, containing information such as, but not limited to, name, address and products. Users will be able to contact these suppliers through Qualifyze when interested in buying products and services from them. 

(b) Qualifyze hereby grants Users a nonexclusive access license to use the Platform Services as necessary for User’s internal business purposes, provided Users comply with the restrictions in these General Terms and Conditions, including but not limited to confidential and non-disclosure obligations.

3. Conclusion of contracts

(1) If the Client wishes to acquire Audit Services or Platform Services, Qualifyze will submit a customized offer for a Subscription Agreement to the Client. The offer is accepted by signing the Subscription Agreement. 

(2) Once subscribed to the Audit Services, the Client has the option to request an increase in the amount of the yearly Credits. In such case, the remuneration for each additional Credit will be subject to a separate agreement between the Parties. Qualifyze shall submit an offer for the additional Credits requested, with a price not less than the remuneration for one Credit as regulated under the Subscription Agreement. The Client may accept the offer by signing a corresponding agreement. Once accepted, the Subscription Agreement will be considered amended. Qualifyze will invoice the additional costs for additional yearly Credits separately. 

The additional Credits shall be applicable to the current Contract Year and the following Contract Years, unless expressly terminated by the Client with 3 month written notice to the end of the respective Contract Year. The additional Credits and the Subscription Agreement cannot otherwise be terminated without cause. 

(3) As entrepreneurs, the Client is not entitled to a right of withdrawal according to §§ 312g, 355 BGB.

4. Audit Services Credits

(1)  For an audit request to be accepted without further remuneration, the Client must have a positive amount of Available Credits.

(2) For New Audit Reports, Credits are redeemed when the audit date is confirmed. If a confirmed date is canceled by the Auditee or the New Audit Report cannot be made available to the Client due to circumstances that do not lie with the Client, that redeemed Credit shall be again made available to the Client.

(3) For Existing Audit Reports, Credits are redeemed when the Auditee authorization has been granted. If the Auditee declines to share the Existing Audit Report or the Existing Audit Report cannot be made available to the Client due to circumstances that do not lie with the Client, that Credit shall be again made available to the Client.

(4) Credits will be:

“Available”: when they have not yet been used by the Client within the respective contract term (“Contract Period”); 

“Pending”: when the individual order for the New Audit Report or the Existing Audit Report has been requested, but the audit date has not yet been confirmed or the sharing of the Existing Audit Report has not yet been authorized by the Auditee; for further clarity, when Credit status is either “validated” or “assigned”, it shall be considered as a Pending Credit under this GTCs.

“Redeemed”: when the audit date has been confirmed or the sharing of the Existing Audit Report has been authorized by the Auditee.

(5) The number of Credits to be used in each audit request will vary according to the complexity and nature of the audit in accordance with the following table, unless otherwise agreed:

Credit Type Audit Scope/Type Number of purchased Credits to be used
“Standard Audits” according to EU/US regulatory framework GMP (API), GMP (EXP), GMP (FDF), GMP (PACK), GMP (MD), GMP (Cosmetics), ISO 9001, GMP (Subcontracted lab), GDP, GMP (Food), GMP (starting materials) 1
“Specialized Audits” PV, GCP, CSV (Software), GLP, Other ISO, any specific (not EU or US) regulation of the standard credit type; ESG audits 2
Additional Credits Extra Services: additional audit days and/or auditors on demand, observers demand, fire requests, coverage of multiple audit standards, customized auditor selection) +1*
Exclusive audits: Mock-inspections, Gap analysis, Inspection preparation, Internal audits, Audits outside QF Cycle +3

*Per Extra Service except otherwise agreed.

5. Audit Services Process for New Audit Reports

(1) After the audit is requested, Qualifyze will contact the respective Auditee and request authorization to perform a New Audit.

(2) As soon as the authorization is received, Qualifyze shall start organizing the New Audit, coordinate possible dates with the Auditee and appoint the corresponding Auditor.

(3) The New Audit Report will generally be accessible to the Client on the Qualifyze Platform within the timeframe specified in the Subscription Agreement in accordance with the Service Plan counting from the corresponding audit date. Qualifyze is not responsible for any delays caused by the Auditee on the delivery of the audit report. In case urgent feedback is required before the audit report is uploaded to the Qualifyze Platform or in case of critical observations, some preliminary information can be issued upon request, describing and assessing the most relevant observations found during the audit within 2 (two) weeks from the corresponding audit date. 

(4) Once scheduled, Qualifyze is not responsible for any changes the Auditee might impose on the date, facilities and/or products allowed to inspect during the New Audit. Once the audit has been scheduled, the Credit will be considered redeemed. If the Client cancels the request once the audit has been scheduled, Qualifyze will not make such Credit available to the Client again. Notwithstanding the foregoing, if the Client cancels a request for a Shared Audit, the Credit will be made available to the Client again, provided that the Client is not the only Client that has requested such a Shared Audit and there are at least 8 (eight) weeks remaining before the audit date.

(5) Qualifyze shall urge the Auditee to submit a Corrective and Preventive Action Plan, (“CAPA-Plan“) as soon as possible. After having assessed the proposed corrective actions and timeline, CAPA information will be available on the platform according to service plan levels. The Client has access to ongoing tracking of the Corrective and Preventive Actions (“CAPAs“) in accordance with the respective Service Plan. Regular follow-ups are performed based on the established timelines as set out in the CAPA-Plan.

(6) After a New Audit is conducted and the New Audit Report is made accessible to the Client on the Qualifyze Platform, the New Audit Report shall be added to Qualifyze’s audit report database for the purpose of reselling the audit report to other Clients. Any non-applicable or confidential information is removed from newly created reports.

6. Audit Services Process for Existing Audit Reports

(1) After the audit report is requested, Qualifyze will contact the respective Auditee and request authorization to share the Existing Audit Report with the Client.

(2) As soon as the authorization from the Auditee is received, Qualifyze will prepare a customized audit report for the Client. If the Client cancels the request for the Existing Audit Report once the process has been already initiated by Qualifyze, Qualifyze will not make such a redeemed Credit available to the Client again. 

(3) The Existing Audit Report and CAPA-Plan (if available) will be submitted to the Client within 10 (ten) working days from the Auditee’s authorization date provided that the original audit report is already available in the Qualifyze Platform.

(4) Qualifyze is responsible for the ongoing tracking of the CAPAs as of the CAPA-Plan. Regular follow-ups are performed based on the established timelines as set out in the CAPA-Plan.

7. Term and Termination

(1) The Subscription Agreement shall become effective as of the Effective Date of the Subscription Agreement and shall remain in effect for a period of 3 Contract Years. 

(2) The Subscription Agreement shall be renewed automatically after each Contract Period for an additional 12-month period each renewal unless either Party decides to terminate the Subscription Agreement with 3-months written notice prior to the end of the respective Contract Period. The Subscription Agreement cannot otherwise be terminated without cause. The right to extraordinary termination remains unaffected.

8. Payment and Invoicing

(1) Our prices are net prices, i.e. plus any value added tax at the statutory rate. 

(2) The Client shall pay the respective remuneration per each Contract Year, which is agreed in the respective Subscription Agreement between the Parties, in one payment at the beginning of the respective Contract Year for access to the Qualifyze Platform. 

(3) The Parties agree that for each Contract Period the respective remuneration will increase as established in the Subscription Agreement.

(4) The yearly invoice (“Invoice”) shall be issued on the day after the conclusion of the Subscription Agreement or within two weeks after its renewal. 

(5) Regarding Audit Services, if the Client and Qualifyze have concluded an Amendment for Increasing yearly Credits in line with Clause 3 para. 2 above, Qualifyze will invoice the additional costs for these Credits separately. The remuneration for the provision of an additional Credits and the corresponding provisions in the respective Amendment for Increasing yearly Credits will become due and payable upon the issuance of the Invoice.

(6) The Client is obliged to provide complete and truthful information about his billing address (including the name of the company, legal form, street and house number, P.O Box number, city code, city, country, billing e-mail address) upon conclusion of a Subscription Agreement. If there are any changes to the billing address, the Client is obliged to inform Qualifyze about these changes without undue delay. If the Client requires to state the purchase order number on the invoice, they must provide this number in a timely manner, at least 2 (two) weeks after the conclusion of a Subscription Agreement.

(7) Unless otherwise agreed, the payment term is 30 (thirty) days from the receipt of an Invoice. Any delay may result in a temporary suspension of the services under the Subscription Agreement. In the event of the Client’s failure to pay any installment due under the Subscription Agreement in full and on time, Qualifyze’s reserves the right to take appropriate actions under the applicable regulation (“Appropriate Actions”), including but not limited to engaging a debt collector to recover the outstanding amount. The Client shall be liable for any and all costs incurred by Qualifyze for such Appropriate Actions , including but not limited to fees, charges, and expenses associated with the Appropriate Actions.

(8) The Client shall only be entitled to set-off or retention rights against our claim for remuneration to the extent that the existence of the counterclaim is not disputed by Qualifyze or has been legally established or results from the same contract under which our service was provided.

(9) Upon request, Qualifyze may invoice in any currency previously agreed upon by the Parties based on the daily ECB exchange rate on the day of invoicing at the time the Invoice is generated.

(10) The remuneration will be an all-inclusive price. Other charges such as travel expenses or allowances for the services provided by Qualifyze will not be charged to the Client.

9. Performance period, cooperation and subcontracting

(1) Exclusive Audits and Shared Audits shall be performed within the agreed timeframe. However, Qualifyze reserves the right to make subsequent changes to any agreed period, and any other related changes, due to the necessary coordination of dates with the Auditee. Clients will be informed immediately of any delays of which Qualifyze becomes aware.

(2) The Client shall support and assist Qualifyze if and to the extent necessary for the purpose of conducting the audits and preparing the corresponding audit reports successfully and satisfactorily. All deadlines agreed with the Client presuppose that all necessary information and documents for the proper performance of the services are provided in sufficient anticipation for the correct preparation of the audit. 

(3) The Client hereby authorizes Qualifyze to, at its sole discretion, subcontract the performance of part of the services under the Subscription Agreement exclusively to its Affiliates and qualified Auditors. Qualifyze shall not subcontract the services in its entirety. Qualifyze shall remain fully responsible for the performance of any services subcontracted in accordance with this Clause 9, and the use of such subcontractors shall not relieve Qualifyze of its obligations under the Subscription Agreement.

10. Use of and registration on our website

(1) Qualifyze´s audit list can be found free of charge on www.qualifyze.com

(2) Registration is free of charge on www.qualifyze.com. The information required for registration must be provided completely and truthfully. When registering, users shall enter with an e-mail address and choose a password. The e-mail address shall not infringe the rights of third parties or other name and trademark rights or offend common decency. Users are obliged to keep passwords secret and not to disclose it to third parties under any circumstances.

(3) The registration does not entail any obligations other than agreeing to the present General Terms and Conditions. User accounts can be deleted at any time. A corresponding option can be found in the administration area of the account. The creation of a user account does not create any obligation related to the services and products offered by Qualifyze.

11. Warranty and liability

(1) These General Terms and Conditions obligate Qualifyze to perform its activities by qualified personnel to the best of its knowledge. These General Terms and Conditions do not create a partnership, joint venture, or other legal entity between the Parties. Neither Party has the authority to bind the other to any third Party. Insofar as Qualifyze provides mere services, it cannot guarantee any particular outcome or success.

(2) If a defect occurs during the performance of a contract for work, the statutory provisions shall apply. A defect shall be deemed to exist if Qualifyze’s performance falls short of what was contractually agreed. Qualifyze cannot guarantee the general usability of audit reports (e.g. acceptance of the audit report or conclusions based on it by third parties) or any other expectations that are not covered by the respective Service Plan. A lack of representativeness of an audit report is generally not a defect either, because audits are carried out on the basis of random samples (cf. Clause 2 (f)).

(3) The statutory liability of Qualifyze and/or its representatives or vicarious agents for damages shall be limited as follows:

  1. Qualifyze’s liability is limited to the amount of damages typically foreseeable at the time of the conclusion of the contract, however, not exceeding a maximum amount of EUR 250,000 (“Maximum Liability Amount”) for the slightly negligent breach of Primary Obligations arising from the contractual obligation. The term “slightly negligent breach” shall be understood as failure to exercise the care that a reasonably prudent person would have exercised under the same circumstances and the term “Primary Obligations” refers abstractly to such obligations whose fulfillment is essential to the proper execution of the contract and the compliance on which the respective other party may regularly rely on. 
  2. Neither Party shall be liable for the slightly negligent breach of non-essential obligations arising out of the contractual obligation.
  3. Qualifyze’s liability is excluded for any failure to perform its obligations under the Subscription Agreement, if such failure is related to or caused by a “Force Majeure Event”. A Force Majeure Event is the occurrence of any event or circumstance beyond the reasonable control of a Party, including, but not limited to, war, natural disasters, fire, flood, explosions, earthquakes, atmospheric disasters, exceptional traffic and road situations, strikes, lockouts, civil unrest or pandemic events. In the event of a Force Majeure Event, the affected Party shall promptly notify the other Party in writing, providing a proof of such Force Majeure Event and try its best to minimize the possible inconveniences. 
  4. Qualifyze´s liability is excluded for any damages resulting from data loss, insofar as these arise from the fact that it is not possible or difficult for the Client to retrieve the data due to missing or insufficient data backup.

The term “representatives” shall mean the employees, directors, officers, consultants, agents, representatives and advisors, including, without limitation, attorneys, accountants, bankers and financial advisors of a Party or its Affiliated Company. 

(4) The aforementioned limitations of liability shall not apply in cases of mandatory statutory liability, in particular in accordance with the German Product Liability Act, in the event of assumption of a guarantee, in the event of damage to life, body or health caused intentionally or with negligence, in the event of intentional breaches of the confidentiality obligation and in the event of other damages based on a grossly negligent breach of duty by Qualifyze or on an intentional or grossly negligent breach of duty by a legal representative or vicarious agent of Qualifyze. The term “grossly negligent breach”  shall be understood as significant deviation from the standard of care expected in a given situation, where a person fails to recognize an obvious risk or ignores basic standards of caution. The Maximum Liability Amount shall not apply in the event of gross negligence on the part of Qualifyze and/or its representatives or vicarious agents.

(5) Qualifyze is obliged to adequately insure the reasonable liability risks arising from the respective Subscription Agreements. 

(6) Qualifyze assumes no liability for the correctness, completeness, topicality, quality, and constant availability of the information provided on www.qualifyze.com. Qualifyze expressly reserves the right to change, supplement or delete parts of www.qualifyze.com or its entire online presence without separate notification or to discontinue publication either temporarily or permanently.     

(7) QUALIFYZE HEREBY DISCLAIMS ANY RESPONSIBILITY OR LIABILITY FOR ANY MISUSE, MISINTERPRETATION, OR ANY EFFECTS RESULTING FROM THE UTILIZATION OF THE INFORMATION OBTAINED THROUGH THE PLATFORM SERVICES. IT IS THE USER’S RESPONSIBILITY TO EXERCISE DUE DILIGENCE AND VERIFY THE ACCURACY OF THE INFORMATION. 

(8) QUALIFYZE DISCLAIMS ANY LIABILITY ARISING FROM THE USE OF THE PLATFORM SERVICES, IN CASES WHERE THE LAW DOES NOT PERMIT SUCH DISCLAIMER, the maximum liability of Qualifyze and/or its representatives or vicarious agents for damages shall be limited to the amount of damages typically foreseeable at the time of the acceptance of these General Terms and Conditions, not exceeding a maximum of EUR 100 (“Maximum Liability Amount”).

12. Copyright and rights of use, confidentiality

(1) Qualifyze´s trademarks, patents, inventions, trade secrets, copyrights, software, symbols, designs, illustrations, drawings, diagrams, logos, and other intellectual property, including but not limited to the company and product information presented on www.qualifyze.com, are protected by trademark, patent, copyright and other intellectual property laws and regulations. They may not be reproduced or otherwise used or made available to third parties without our written consent. Unauthorized use of our intellectual property will be considered a severe infringement and a contract breach. 

Client hereby grants Qualifyze a non-exclusive, royalty-free, worldwide license to use Client’s name, logo and trademarks for advertising, marketing and promotional purposes. This includes, but is not limited to displaying Client’s name, logo and trademarks on the Qualifyze website, platform, marketing materials, sales materials, presentations, social media, and other commercial communications.

(2) Regarding the use of the audit reports or any information obtained from the Platform Services, including any test results, calculations, descriptions, and other related documents:

The audit reports provided to the Client are confidential information, which is also subject to copyright protection; they are only intended for use by the Client´s company and must be kept secret and confidential from third parties;

Qualifyze is the sole and exclusive owner of the audit reports. Qualifyze grants the Client a simple, non-transferable, and non-sublicensable right of use of the audit report ordered, subject to full payment of the remuneration owed for it, to use the audit report exclusively for its own (internal) purposes, and to make it available only for these own purposes to authorities, courts, marketing authorization holder, the entity responsible for the manufacturing (including the Qualified Person) or affiliates (as defined by sections 15 ff. of the German Stock Corporation Act (Aktiengesetz,“AktG”)), insofar as these authorities, courts or affiliates are themselves bound by law or contract to maintain confidentiality (i.e. consultants, certification bodies, affiliates) and it is allowed under separate agreements between the Client and the respective Auditee. The use includes both the permanent storage and duplication of the audit report on any number of the internal equipment as well as the making of individual paper copies for internal use;

Beyond the aforementioned assumption, Client agrees that it will not transfer the use of its Credits to any of its Affiliated Companies without the prior written consent of Qualifyze. If Client engages directly (i.e., with Qualifyze’s written consent) or indirectly (i.e., by sharing an audit report internally with its Affiliated Companies) one or more of its Affiliated Companies in these General Terms and Conditions, Client agrees to convey the terms of these General Terms and Conditions to said Affiliated Companies, which will be considered party to the Subscription Agreement and these General Terms and Conditions;

The Client is not permitted to use audit reports or parts thereof for purposes other than internal company purposes. In particular, the Client is not permitted to copy audit reports or parts thereof, to make them publicly accessible or to make them available to third parties for their own use or to allow access to them;

Qualifyze is entitled to provide the audit reports with a technical access restriction (e.g. password) to protect them from improper use. It is not permissible to overcome or circumvent this security measure. Any access passwords must be kept secret and protected from access by third parties;

The Client may not remove any references to the owners of the copyrights of the audit reports. 

(3) Any use that goes beyond the use permitted in this Clause 12 requires Qualifyze´s prior express consent in writing unless it is permitted by law.

(4) “Confidential Information” under these General Terms and Conditions and/or any  Subscription Agreement shall mean all information about a Party and/or its Affiliated Companies and/or its respective representatives (“Disclosing Party“), as well as their respective businesses and affairs, which was or is obtained either verbally or in writing or electronically or in any other form at any time (before, on or after the signing of the respective Subscription Agreement and irrespective of who provided such information and how such information was provided) by the respective other Party and/or its Affiliated Companies and/or its representatives (“Receiving Party“). 

Confidential Information received by the Parties can be disclosed by the Parties to their Affiliated Companies, under these General Terms and Conditions and the respective Subscription Agreement, provided that such Affiliated Companies are aware of and comply with the confidentiality obligations contained in these General Terms and Conditions and the respective Subscription Agreement and protect it against unauthorized access by third parties. All employees, officers, directors, representatives, attorneys, consultants and agents, of the Client and employees, officers, directors, representatives, attorneys, consultants and agents of any of the Client´s Affiliated Companies that are in contact with the audit reports or are disclosed any Confidential Information must be bound by confidentiality obligations at least as strict as the ones applying to the Client and for equivalent timeframes.   

Affiliated Company” or “Affiliated Companies” shall mean any company directly or indirectly owned or controlled by a Party, or any company under directly or indirectly ownership or control as any Party, or any company directly or indirectly owned or controlled by a Party. Ownership or control shall exist through the direct or indirect ownership or control of more than 50% of the nominal value of the issued equity share capital or of more than 50% of the shares entitling the holders to vote for the appointment of directors or persons performing similar functions. Ownership or control shall also exist when there is power to direct or cause the direction of the management or policies of the company by any means.

(5) The confidentiality obligations under these General Terms and Conditions and/or any Subscription Agreement include, in particular but not limited to, the following Confidential Information:

  1. The contents of the Subscription Agreement; 
  2. The Parties and/or their Affiliated Companies’ operations, activities, business and finances; 
  3. The Parties and/or their Affiliated Companies’ suppliers, customers, account records, budgets and ledgers; 
  4. Any information designated in writing or orally or electronically by the Parties and/or their Affiliated Companies marked as “confidential”;
  5. Any information about Auditors; 
  6. Any information about Auditees; 
  7. The content of the audit report; 
  8. Any information obtained in the Qualifyze Platform through the Platform Services. 

(6) Confidential Information also includes trade secrets which have an economic value, are protected by appropriate confidentiality measures and where there is a legitimate interest in keeping them confidential (“Trade Secret“). Any information or materials that constitute a Trade Secret and are labeled as such may be disclosed under these General Terms and Conditions and/or any Subscription Agreement by a Disclosing Party only if prior to such disclosure the potential recipient has been advised of the intent of the Disclosing Party to reveal a Trade Secret under these General Terms and Conditions and/or any Subscription Agreement, and the recipient has given its written consent to receive such Trade Secret under these General Terms and Conditions and/or any Subscription Agreement.

With respect to any Trade Secret permissibly disclosed under these General Terms and Conditions and/or any Subscription Agreement, the recipient shall use the highest level of protection that it uses for its own Trade Secret, but in any case no less than a reasonable degree of care, to prevent any unauthorized use, disclosure, dissemination or publication thereof, or other more stringent protections as may be agreed in writing by the Disclosing Party and recipient.

(7) The audit report and the information obtained in the Platform Services are for internal use of the Client and its Affiliated Companies, provided that the Affiliated Companies are bound to confidentiality obligations as strict as the ones set forth in these General Terms and Conditions and/or any Subscription Agreement and for equivalent timeframes. 

The Client is permitted to disclose the audit report to the authorities when requested and when bound by law or judicial or government order. If the Client has a genuine interest and needs to share the audit report with other parties (e.g., its customers) prior written authorization from Qualifyze and the corresponding Auditee is required. No additional fee will be charged in this case.

Qualifyze is entitled to add the audit report to its database and to resell it provided that all of Client’s Confidential information is removed from the audit report prior to it being added to the Qualifyze’s database. 

(8) The Parties are obliged to take all necessary and appropriate measures to avoid the non-authorized disclosure of Confidential Information vis-à-vis third parties and/or the unauthorized access of Confidential Information by third parties.

(9) The Parties undertake to exercise the same degree of care and protection they take to preserve their own Confidential Information. Neither Party makes any representation or warranty as to the accuracy or completeness of its Confidential Information. The disclosing Party will not be liable for any use of its Confidential Information, or by any error or omission concerning its Confidential Information.

(10) Upon written request from the Disclosing Party, the Receiving Party will, within 30 business days, return to the Disclosing Party all documents and other materials in the Receiving Party’s possession containing Confidential Information of the Disclosing Party. The Disclosing Party might, at its sole discretion, request the Receiving Party to destroy all documents and other materials in the Receiving Party’s possession containing Confidential Information of the Disclosing Party.  

Notwithstanding the foregoing, (a) the Receiving Party may retain one copy of all documents and other materials containing Confidential Information of the Disclosing Party for archival, compliance and legal purposes, and (b) the Receiving Party shall not be required to destroy any securely stored computer files that contain Confidential Information of the Disclosing Party created during automatic system back-ups and/or archiving systems, provided that the Confidential Information so retained remains subject to the confidentiality obligations set forth in these General Terms and Conditions and/or any Subscription Agreement.

(11) No confidentiality obligations shall apply to information, materials and documents which:

  1. are already known or in the possession of the Receiving Party prior to their receipt;
  2. are legally received by the Receiving Party from a third party without any confidentiality obligations;
  3. are in the public domain or enter the public domain through no wrongful act of the Receiving Party;
  4. can be proven by the Receiving Party to have been developed independently of Confidential Information received from the Disclosing Party;
  5. are required to be disclosed by any applicable law, regulation, legal processes, government authority or courts, subject to prior notice to the Disclosing Party to the extent reasonably possible; or 
  6. are approved in writing by the Disclosing Party not to be treated as confidential.

If and when requested, the Receiving Party has to furnish evidence of facts constituting one of the aforementioned exemptions.

(12) The confidentiality obligations pursuant to these General Terms and Conditions and/or any Subscription Agreement and/or any Amendment for Increasing yearly Credits, shall survive and continue for a period of 7 years after the expiration or termination of the respective Subscription Agreement.

(13) The Client shall take all reasonable and appropriate measures to safeguard confidential information against theft, loss, leak and unauthorized disclosure to third parties. In the event of any breach or violation of the confidentiality obligations attributable to the Client leading to Qualifyze’s liability towards the Auditee or Supplier, Qualifyze shall have the right to seek full recourse against the Client, including the recovery of all indemnification amounts paid by Qualifyze to the Auditee or Supplier, as well as legal fees and any other associated costs. 

(14) The Client shall notify Qualifyze immediately in case of theft, loss, leak or unauthorized disclosure of any confidential information and provide all necessary assistance to Qualifyze to mitigate the potential damages provoked by said theft, loss, leak or unauthorized disclosure.

(15) The Parties agree that, during the term of this agreement none of them will make any public statements which materially disparage the other party. Notwithstanding the foregoing, nothing in this Clause 12 shall prohibit any person from making truthful statements when required by law, order of a court or other body having jurisdiction.

13. Data protection 

(1) The signatories and the contact persons are informed that their personal data will be processed by Qualifyze GmbH as controller of the data. Qualifyze shall observe any applicable data protection regulation, in particular, the provisions of the General Data Protection Regulation UE 2016/679 (Datenschutz Grundverordnung, “DSGVO”) and the Telecommunications and Telemedia Data Protection Act (Gesetzes zur Regelung des Datenschutzes und des Schutzes der Privatsphäre in der Telekommunikation und bei TelemedienTTDSG”). The legal basis for the processing is the performance of the contract.  The data may be transferred to the Affiliates of Qualifyze for administrative purposes only, as well as Auditees and appointed traders within or outside the European Union. 

(2) Qualifyze GmbH may process certain personal data of the users of the platform in accordance with the Website and Application Privacy and Cookie Policy available in the following link, for the performance of the contract. The Client undertakes to inform the users of the platform about the content of the Privacy Policy. Likewise, it’s the Client responsibility to communicate to Qualifyze the emails of the users that have to be included in the Client company account, as well as to inform Qualifyze as soon as the users have to be replaced or removed from such a Client company account.      

The data subject may exercise the rights to access, rectification or erasure of the data, restriction of processing and portability, as well as withdraw the consent, without affecting the lawfulness of the processing based on consent before its withdrawal, by sending a written request to the Data Controller, whose contact details may be found in section 1. They may also lodge a complaint with a supervisory authority. The data will be stored for the duration of the contractual relationship and even after the termination until the appropriate legal actions for this purpose expire.  

(3) Client guarantees that any personal data transferred to Qualifyze for the performance of this Subscription Agreement has been collected in compliance with the applicable data protection regulations. Client further agrees that it will only provide Qualifyze with the personal data strictly necessary for the provision of the services under this Subscription Agreement or the GTC and that it has obtained the consent of the data subjects or it is transferred in accordance with the applicable regulations. Qualifyze agrees to use the personal data solely for the performance of the services, and shall request the data subject’s prior consent to use the personal data for any purpose other than the performance of this agreement. If any further processing of personal data is required for the performance of the services on behalf of the Client, the Data Processing Agreement (DPA) available at https://qualifyze.diga-33.com/data-privacy/  shall apply. 

(4) For further information on the treatment of personal data by Qualifyze see www.qualifyze.com/data-privacy/.

14. Governing law 

(1) These General Terms and Conditions and any contract entered into by the Client and Qualifyze are subject to the law of the Federal Republic of Germany, without regard to its conflict of laws rules and principles. The provisions of the UN Convention on Contracts for the International Sale of Goods (CISG) will not apply to these General Terms and Conditions nor to any contract entered into by the Client and Qualifyze. 

(2) The Parties agree that they shall in good faith work towards implementation of these General Terms and Conditions and any dispute arising out of or in relation to these General Terms and Conditions shall be first attempted to be resolved amicably by mutual negotiations or mediation. Whether this resolution method turns unsuccessfully, Parties shall resort to the courts at Qualifyze´s registered office in Frankfurt am Main (Germany). In such a case, the courts located in Frankfurt am Main, shall have exclusive jurisdiction for the disputes arising from or in connection with these General Terms and Conditions and any contract entered into by the Client and Qualifyze, including those concerning its existence, validity, performance, expiration or termination. However, at the sole discretion and option of Qualifyze. Qualifyze shall also be entitled to assert claims against the Client at its general place of jurisdiction.

15. Compliance 

(1) Both Parties represent and warrant compliance with national and international laws and regulations applicable to their respective activity. The Client agrees to comply with Qualifyze’s Business Principles throughout its business relationship with Qualifyze adhere to them in all relevant dealings. Said principles, which include but are not limited to compliance with human rights, labor practices, anti-bribery, anti-corruption, anti-money laundering, antitrust, and fair competition standards, can be consulted at any time via the following link: Qualifyze’s Business Principles

(2) The Parties warrant to conduct their activities in accordance with the notions and principles of ethics, impartiality, and honesty, avoiding direct and/or through third parties, involvement in illegal commercial activities, that includes conducting commercial activities subject to trade sanctions laws (the U.S. Department of the Treasury’s Office of Foreign Assets Control sanctions regulations  – “OFAC”, the U.S. Export Administration Regulations, the UK Export Control Act of 2002, and the E.U. sanctions regulations).

(3) Client guarantees that it is not considered a Sanctioned Party, neither is owned or controlled, whether directly or indirectly, by a Sanctioned Party, nor it is associated with Sanctioned Party in anyway (“Sanctioned Party” is defined as any individual or entity subject to financial sanctions imposed by the relevant authorities, including, but not limited to, the consolidated list of persons, groups, and entities subject to applicable trade sanctions laws mentioned in the Clause 15 (2) above).

(4) The Client undertakes not to directly or indirectly use, resell, sell, export, re-export, transfer, distribute, dispose of, disclose, or otherwise deal or facilitate the services provided by Qualifyze, directly or indirectly, to any Sanctioned Party or any third party established in a country, territory, or destination with which Qualifyze does not conduct business. Such territories include, but are not limited to, Iran, Syria, Sudan, Cuba, Crimea & Sevastopol, North Korea, Russia, and any other territory subject to Trade Sanctions (“Trade Sanctions” are defined as restrictions or prohibitions imposed by relevant authorities on the supply of services to specific territories or parties). Furthermore, the Client shall undertake its best efforts to ensure that the purpose of this Clause 15 (4) is not frustrated by any third parties further down the commercial chain, including by possible resellers. For that reason, the Client shall set up and maintain an adequate monitoring mechanism to detect conduct by any third parties further down the commercial chain, including by possible resellers.  

(5) In the event that either Party becomes aware of a breach or threatened breach of the obligations under Clause 15, they shall immediately inform the other Party in writing. If Qualifyze deems it necessary, the Client shall provide information concerning compliance with Clauses 15(1) – 15(4) within two weeks of such a request. Any breach of Clause 15 shall be considered a material breach and may lead to the termination of the Subscription Agreement by Qualifyze with immediate effect. Termination shall not relieve the Client of any obligations accrued prior to termination.

(6) In the case where the sub-contractor or business partner of the Client, if any, would not comply with the laws mentioned in the Clauses 15(1) – 15(4) or would breach the applicable regulations or commit any offense, Qualifyze could never be held responsible and the Client shall hold Qualifyze harmless of all the consequences of this breach or offense, whether financial or extra-financial.

(7) In the event of any breach or threatened breach of this Clause 15, in addition to any other remedy available, the Client shall indemnify, and hold Qualifyze and its Affiliated Companies harmless against any and all direct or indirect liabilities, claims, demands, damages, losses, expenses, interests, and penalties suffered by Qualifyze as a result of such breach.

(8)  If the Client knows or suspects that any of Qualifyze ’s employees, Affiliated Companies or representatives may have violated the laws or regulations mentioned in Clause 15, Qualifyze encourages the Client to report this to Qualifyze through the available whistleblowing channel: https://qualifyze.diga-33.com/whistleblowing-channel/

Qualifyze undertakes to process the report within the principle of confidentiality, and investigate it, maintaining the objectivity and reliability.

16. Miscellaneous

(1) No Party may assign any rights or claims under these General Terms and Conditions and/or any Subscription Agreement without the prior written consent of the other Party (within the meaning of section 126 b BGB). This will not apply to assignments to Affiliated Companies of the assigning Party or successors of the Parties.

(2) In case of discrepancies among different contracts signed by the Parties, the following order of precedence shall apply for interpretation and enforcement: 

  1. CDAs (Confidential Disclosure Agreements). 
  2. Subscription Agreements. 
  3. General Terms and Conditions. 
  4. Quality Agreements. 

(3) These General Terms and Conditions and the Subscription Agreement supersede all prior agreements and conventions, oral and written declarations of intent and other arrangements or side agreements (whether binding or non-binding) made by the Parties in respect thereof.

(4) The failure or delay by either Party in exercising or enforcing any right, remedy or power under these General Terms and Conditions and/or any Subscription Agreement shall not constitute or operate as a waiver of that right, remedy or power. The single or partial exercise or enforcement of any right, remedy or power under these General Terms and Conditions and/or any Subscription Agreement shall not preclude or restrict any further exercise or enforcement of that right, remedy or power, or the exercise or enforcement of any other right, remedy or power under these General Terms and Conditions and/or any Subscription Agreement. 

(5) Each Party represents and warrants to the other Party that it has the legal power and authority to enter into and perform under these General Terms and Conditions and/or any respective Subscription Agreement.

(6) By accepting these General Terms and Conditions, you represent and warrant that you have full power and authority to enter into these General Terms and Conditions on behalf of yourself, the User, or the company you represent, and to bind them to these General Terms and Conditions. If you are accepting these General Terms and Conditions on behalf of a company or legal entity, you further represent and warrant that you have obtained all necessary authorizations and approvals from the appropriate individuals or governing bodies within that legal entity to accept these General Terms and Conditions on its behalf. If you do not have the necessary authority or if you do not agree with these General Terms and Conditions, you must not accept this agreement and may not use the services.

(7) The Parties agree that the clauses in this General Terms and Conditions will remain in force until full completion of the service and the legal responsibilities of each party cease. Notwithstanding the foregoing, copyrights and rights of use provided in Clause 12 of this General Terms and Conditions shall survive the expiration or termination of the Subscription Agreement; and confidentiality obligations established in the Clause 12 of this General Terms and Conditions shall survive the expiration or termination of the Subscription Agreement for a period of 7 (seven) years.

(8) Client and User agree that they shall not use any automated systems, software, bots, or other known or unknown methods to scrape, extract, or collect data from Qualifyze’s platform, databases, website or systems without prior written consent of Qualifyze. Any unauthorized data scraping, data mining, or extraction of information is strictly prohibited and considered a breach of these General Terms and Conditions. Additionally, Qualifyze has a Vulnerability Disclosure Policy available at the following link https://qualifyze.diga-33.com/information-security-policy/.

(9) Qualifyze reserves the right, at its sole discretion, to improve by modifying or amending these General Terms and Conditions, the Privacy Policy and Data Processing Agreement at any time Qualifyze shall provide prior written notice to the Client at least 15 (fifteen) days before to the effectiveness of the modifications. The Client’s use of the Qualifyze Platform after the effective date of any material modification will constitute acceptance of the modified General Terms and Conditions. Qualifyze is not required to provide prior notice if the modifications are necessary to comply with the applicable laws, but will provide notice when possible. Likewise, Qualifyze reserves the right to update the list of services it provides without providing prior written notice.  

(10) Each of the Parties agrees that the electronic signatures used in execution of these General Terms and Conditions and/or any Subscription Agreement, are legally binding, have the same legal effect as traditional handwritten/wet ink signatures and constitute an original for all purposes. The Parties also agree that exchanging scanned copies of these General Terms and Conditions and/or any Subscription Agreement, any subsequent amendments containing traditional handwritten/wet ink signatures via email or accepting Amendment through the link to the Qualifyze Platform is legally binding and has the same legal effect as exchanging hard copies. 

(11) English language terms used in these General Terms and Conditions and all contracts between the Parties only describe German legal concepts and shall not be interpreted by reference to any meaning attributed to them in any jurisdiction other than Germany.

Annex 1 Audit service plans

Standard Premium
Report Delivery (new and shared) 45 days 30 days
Report Delivery (existing) in days 5d 3d
Access to Digital Audit Management Platform ✔️ ✔️
Upfront Auditor CV ✔️ ✔️
CAPA Follow up ✔️ ✔️
CAPA Adequacy ✔️ ✔️
Digital CAPA Management ✔️ ✔️
Audit Agenda ✔️
Customer Care Standard White Glove
Credit Schema Multicredit Multicredit

Audit Standards

Qualifyze understands there may be different applicable Audit Standards to be considered upon the Client’s request. The applicable Audit Standards by default shall be the following, unless the Client expressly requests otherwise at the time of requesting the Credit:

Quality Type

Auditing Standard

GDP_DISTRIBUTION

for API EC Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)

for FDF EC Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)

GMP_API

ICH Q7 // EU GMP Part II

GMP_EXCIPIENTS

2022 IPEC – PQG Good Manufacturing Practices Guide for pharmaceutical excipients

GMP_FDF

EU GMP Part I + Annexes

GMP_LABORATORY

EUGMP Part I or EUGMP Part II / ICH Q7

GMP_PACKAGING

ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP).

GMP_STARTING_MATERIALS

APIC GUIDE for auditing registered starting material manufacturers

ISO_9001

ISO 9001:2015

GMP_SECONDARY_PACKAGING

ISO 9001:2015

ESG

GRI Sustainability Reporting Standards

FOOD

ISO 22000:2018 Food Safety Management Systems – Requirements for any organization in the food chain

COSMETICS

ISO 22716:2007 Cosmetics Good Manufacturing Practices (GMP).

GAMP_SOFTWARE

GAMP 5 – second edition

GCP_CLINICAL

ICH Guideline for Good Clinical Practice E6 (R2)

GLP_LABORATORY

Good Laboratory Practice (GLP)

GMP_MED_DEV

EU MDR (2017/745) ISO 13485:2016

GVP_COVIGILANCE

Guideline on Good Pharmacovigilance Practices (GVP)

Published: May 18th, 2026.

1. General provisions

These Quality Technical Conditions (“QTC”) set forth the responsibilities and expectations of Qualifyze’s client/s (“Client” or “Clients”), as identified in the applicable Subscription Agreement or Order Form (“Subscription Agreement”), and Qualifyze GmbH or Qualifyze Inc. (hereinafter individually each as “Qualifyze”), in the course of fulfilling its obligations under the relevant Subscription Agreement, with respect to Audit Services.

Qualifyze and the Client are also referred to collectively as the “Parties” and each as a “Party”. Any capitalized terms used but not defined in this QTC shall have the meaning ascribed to them in the Subscription Agreement and/or the General Terms and Conditions concluded between the Parties.

Qualifyze shall provide Audit Services, including planning, execution, reporting, and follow-up of corrective and preventive actions. Audits shall assess compliance with applicable standards and regulations.

Qualifyze operates as an independent service provider. These QTC do not create a partnership, joint venture, or employment relationship. The Client retains ultimate responsibility for regulatory compliance and quality outcomes.

If a Subscription Agreement and General Terms and Conditions have been signed between the Parties, all their terms, including those on confidentiality, data protection, liability, indemnification, intellectual property, credits, governing law, dispute resolution, and other commercial matters, also apply to this QTC. Any references in those documents to the Subscription Agreement or General Terms and Conditions should be read as references to this QTC where relevant, unless this QTC says otherwise.

In the event of any conflict, inconsistency, or discrepancy between the provisions of this QTC, the Subscription Agreement, and/or the General Terms and Conditions, the following order of precedence shall apply: (a) for quality-related topics, including but not limited to audit standards, auditor qualifications, audit execution, reporting, and CAPA follow-up, these QTC shall prevail; provided, however, that if a separate Quality Technical Agreement (“QTA”) has been individually negotiated and executed between Qualifyze and the Client, such separately executed QTA shall prevail over this QTA; (b) for commercial-related topics, including but not limited to pricing, credits, payment terms, subscription plans, and service levels, the Subscription Agreement shall prevail, followed by the General Terms and Conditions; and (c) for all other matters not falling within (a) or (b), the Subscription Agreement shall prevail, followed by the General Terms and Conditions and then the QTC.

These QTC, the Subscription Agreement and the General Terms and Conditions, are intended to be read together as complementary documents forming part of a single contractual framework governing the relationship between the Parties.

By executing the Subscription Agreement, the Client expressly acknowledges and agrees to be bound by the terms and conditions set forth in these QTC. The Client’s use of the Audit Services shall at all times be subject to compliance with these QTC, as amended from time to time in accordance with Section 10.

These QTC shall remain in effect for the duration of such Subscription Agreement and shall terminate upon termination thereof. Notwithstanding the foregoing, any provisions of this QTC that by their nature relate to obligations or actions still pending completion at the time of termination, or that are intended to survive termination, including, without limitation, provisions relating to confidentiality, liability, audit record retention, and any ongoing corrective or preventive actions shall remain in full force and effect until such time as the relevant obligations have been fulfilled in their entirety.

These QTC are concluded exclusively in English. In the event of any translation of these QTC, the English language version shall prevail.

2. Scope of services

The scope of services provided by Qualifyze, including the Audit Services and the Platform Services, and the distinction between Shared Audits and Exclusive Audits, is set forth in the General Terms and Conditions. This QTC addresses the quality-technical aspects of such services as they relate to the Audit Services.

The findings of Qualifyze’s Audit Reports are based on a sampling process aimed at obtaining the most reliable possible evidence of compliance or non-compliance with the applicable audit criteria. There may be other business aspects that were not examined by the auditor appointed by Qualifyze (“Auditor”) and which may justify different conclusions. It is the sole responsibility of the Client to evaluate the conclusions of the audit report.

2. Scope of services

The scope of services provided by Qualifyze, including the Audit Services and the Platform Services, and the distinction between Shared Audits and Exclusive Audits, is set forth in the General Terms and Conditions. This QTC addresses the quality-technical aspects of such services as they relate to the Audit Services.

The findings of Qualifyze’s Audit Reports are based on a sampling process aimed at obtaining the most reliable possible evidence of compliance or non-compliance with the applicable audit criteria. There may be other business aspects that were not examined by the auditor appointed by Qualifyze (“Auditor”) and which may justify different conclusions. It is the sole responsibility of the Client to evaluate the conclusions of the audit report.

3. Audit Standards

(1) Qualifyze understands there may be different applicable Audit Standards to be considered at the Client’s request. The applicable Audit Standards by default shall be the following, unless the Client expressly requests otherwise:

Audit TypeAuditing StandardOnsite/Remote
GDP (DISTRIBUTION) For APIEC Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)Onsite
GDP (DISTRIBUTION) for FDFEC Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)Onsite
GMP (API)ICH Q7 // EU GMP Part IIOnsite
GMP (EXCIPIENTS)2022 IPEC – PQG Good Manufacturing Practices Guide for Pharmaceutical ExcipientsOnsite
GMP (FDF)EU GMP Part I + AnnexesOnsite
GMP (LABORATORY)EU GMP Part I or EU GMP Part II / ICH Q7Onsite
GMP (PRIMARY PACKAGING)ISO 15378:2017 Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP).Onsite
GMP (STARTING MATERIALS)APIC GUIDE for auditing registered starting material manufacturersOnsite
ISO 9001ISO 9001:2015Onsite
GMP (SECONDARY PACKAGING)ISO 9001:2015Onsite
ESGGRI Sustainability Reporting StandardsOnsite
FOODISO 22000:2018 Food Safety Management Systems – Requirements for any organization in the food chainOnsite
GMP (COSMETICS)ISO 22716:2007 Cosmetics Good Manufacturing Practices (GMP).Onsite
GAMP (SOFTWARE)GAMP 5 – second editionRemote
GCP (CLINICAL)ICH Guideline for Good Clinical Practice E6 (R3)Onsite
GLP (PRECLINICAL TESTING LABORATORY)Good Laboratory Practice (GLP)Onsite
GMP (MED DEV)EU MDR (2017/745) ISO 13485:2016Onsite
GVP (PHARMACOVIGILANCE)Guideline on Good Pharmacovigilance Practices (GVP)Remote

(2) By default, all audits shall be conducted onsite, except for GVP audits and software audits, which will be conducted remotely due to the nature of the processes being assessed.

4. New Audit Requests

The Client shall provide all relevant information necessary for Qualifyze to adequately prepare and execute the audit no later than six (6) weeks prior to the scheduled audit date. This may include, but is not limited to:

a. details of the products and services within the audit scope,

b. prior Audit Reports,

c. Auditee action plans responding to previous audits,

d. applicable regulatory requirements,

e. quality agreements with the Auditee,

f. specific focus areas requested for the audit,

g. or any other relevant information the Client wishes Qualifyze to consider.

Qualifyze reserves the right to request additional information from the Client whenever necessary to clarify the scope of the audit, or to address any unclear information that requires clarification. The Client shall ensure timely responses and provide any required clarifications so that Qualifyze can adequately provide the Audit Services.

Qualifyze reserves the right to reject participation in an audit if a request to join an already planned audit is received at a late stage. In such cases, Qualifyze shall communicate the reason for the rejection in a timely manner.

5. New Audit Process and Auditor Qualification

After the audit is requested, Qualifyze shall contact the respective Auditee and request authorization to perform the New Audit. As soon as authorization is received, Qualifyze shall start organizing the New Audit, coordinate possible dates with the Auditee, and appoint the corresponding Auditor.

Qualifyze shall be responsible for scheduling audits, which includes ensuring that the Auditee accepts the audit on a defined and adequate number of days to allow proper execution. Audit scheduling shall take into account, as applicable:

a. The Client’s requirements and any specific timelines requested.

b. The availability of the Auditee.

c. The number and type of products or services included in the audit scope.

d. The availability of qualified auditors.

e. Any other factors that may reasonably affect the planning or execution of the audit.

Once the Auditee confirms the audit date, Qualifyze shall update the confirmed date in Qualifyze’s Platform and notify the Client of such update.

Qualifyze shall make all reasonable efforts to avoid modifications to the scheduled audit dates. Nevertheless, Qualifyze may adjust the audit schedule in Qualifyze’s Platform to address unforeseen circumstances, provided that any such adjustments and their justification are promptly communicated to the Client and the Auditee.

When the Auditee does not accept the number of audit days and/or auditors required to ensure a comprehensive audit, the audit can only be conducted using a systematic (sampling-based) approach. This approach does not guarantee that examples of all products within the audit scope will be reviewed.

As the final audit scope is typically determined shortly before the audit date, the decision to conduct the audit using a systematic approach, together with the applicable scope and its limitations, shall be communicated to the Client at that time and prior to the commencement of the audit. If the Client wishes to ensure that specific products within the requested scope are covered by the audit, an exclusive audit covering those products should be requested, as only such an audit can provide that level of assurance.

Qualifyze shall be fully responsible for ensuring that all auditors assigned to perform audits under this QTC are competent and qualified for the specific audit in question. Auditors may be either:

a. Subcontracted auditors engaged by Qualifyze, or

b. Internal employees of Qualifyze.

For any subcontracted auditors, Qualifyze shall ensure that the following minimum requirements are met prior to assignment:

a. Educational background in life sciences or demonstrable long-term experience in the industry.

b. Strong experience in the pharmaceutical industry, with a minimum of five (5) years.

c. Documented experience in performing audits, with active auditing experience within the last three (3) years.

d. Evidence of relevant and accredited auditor training, or justified experience in auditing under the supervision of experienced inspectors.

e. Proficiency in English at a business fluent level or native, both written and spoken.

In addition, subcontracted auditors shall successfully complete the Qualifyze qualification process, which includes: (i) questionnaire, (ii) interview, (iii) reporting demonstration, and (iv) a witnessed audit when applicable.

For employees of Qualifyze eligible to act as auditors under this QTC, Qualifyze shall ensure that qualification is conducted in accordance with its internal program. Eligible employees must have experience supporting audit preparation and reviewing audit reports in Qualifyze and must possess a background in life sciences. The qualification program includes staged progression under the supervision of a mentor and already qualified Auditor, from observation to co-auditor and lead auditor roles.

Auditors, whether subcontracted or internal, shall be continuously monitored to ensure that high performance standards are maintained.

Auditors must sign a Declaration of Independence (“Declaration”) prior to performing any audit under this QTC, to ensure impartiality and objectivity. In this Declaration, the Auditor represents and warrants that it will maintain independence, objectivity, and impartiality throughout the audit engagement.

The Auditor shall avoid any relationships, financial interests, or prior or concurrent engagements that could reasonably be perceived as creating a conflict of interest or compromising its independence. The Auditor further represents and warrants that it has no relationship with the Auditee that creates or could reasonably be perceived to create a conflict of interest or to compromise the Auditor’s independence, objectivity or impartiality.

The Auditor further represents and warrants that it has been duly appointed and accepted the audit engagement with these principles.

Qualifyze shall provide the Client with the curriculum vitae (CV) of the Auditor(s) assigned to the audit prior to the commencement of the audit. In addition, the CV(s) and the signed Declaration of the Auditor shall be included as attachments to the final Audit Report.

If an Auditor becomes unavailable immediately before, during, or after an audit, Qualifyze shall, provided that another qualified auditor is available and can be appointed without disproportionate additional expense, appoint a substitute auditor. Qualifyze shall promptly notify the Client of any such substitution.

Qualifyze shall be responsible for preparing the detailed audit agenda, taking into account all requirements communicated by the Client. The agenda should include, at a minimum:

a. Identification of the auditee, the audit team, and the Client(s) sponsoring the audit;

b. Applicable audit standards;

c. Processes and areas to be audited;

d. Schedule and duration of the audit sessions, including opening and closing meetings.

The proposed agenda shall be communicated to the Auditee sufficiently in advance to allow for their review and comments. Any adjustments requested by the Auditee shall be considered and agreed upon by Qualifyze and the Auditee prior to the commencement of the audit.

Qualifyze should conduct the audit in accordance with the approved agenda and the Client’s requirements, performing it professionally, impartially, and in compliance with all applicable regulatory and quality standards.

Minor adjustments to the audit agenda may be made during the audit to ensure proper execution, as necessary and based on risk considerations and operational feasibility. Any significant deviations from the approved agenda shall be communicated to the Client and justified by Qualifyze.

Any critical or potentially critical findings or unforeseen situations identified during the audit shall be communicated by Qualifyze to the Auditee as soon as reasonably possible. Where applicable, the Client shall be informed within forty-eight (48) hours of such identification.

6. New Audit Reports

All findings, observations, and conclusions included in the audit report shall be based on objective evidence collected during the audit. Qualifyze shall ensure that all evidence is documented accurately, clearly, and in accordance with internal procedures and applicable audit standards.

Qualifyze shall prepare and deliver the following audit reports:

a. Draft Audit Report: allowing the Client to review a draft and provide feedback during one week from its issuance.

b. Final Audit Report: Incorporating feedback from the Draft Report comments received and signed by the Auditor.

Final Audit Report shall be delivered within the timeframe specified in the applicable General Terms and Conditions and in accordance with the Service Plan.

In the event that urgent feedback is required before the final Audit Report is made available, Qualifyze shall, upon request, provide preliminary information describing and assessing the most relevant observations identified during the audit within two (2) weeks from the corresponding audit date.

Qualifyze shall not be responsible for any delays in the delivery of the audit report caused by the Auditee.

Audit reports prepared by Qualifyze, including both New Audit Reports and Existing Audit Reports, shall include, at a minimum:

a. Identification of the Auditee, including relevant contact details.

b. Identification of the audit team.

c. Name of the Client to whom the report is formally addressed.

d. Clear statement of the audit and scope, including applicable standards or requirements.

e. General overview of the Auditee, such as business activities and key operational characteristics.

f. Description of the audit environment, including conditions that may have influenced the audit.

g. Summary of key strengths identified during the audit.

h. Conclusions regarding the auditee’s compliance based on the evidence collected during the audit.

i. Auditor(s) signature(s).

j. List of Auditee participants involved during the audit, including their roles.

k. Detailed findings, including their classification and references to applicable regulations and standards.

l. Audit evidence, describing in detail the information gathered during the audit that supports the findings and conclusions.

m. Auditor’s curriculum vitae (CV).

n. Auditor Declaration of Independence.

The New Audit Report will be made available through Qualifyze’s online platform. The Client shall receive a notification when the Audit Report becomes available.

7. Existing Audit Reports

When the Client requests an Existing Audit Report, Qualifyze shall contact the respective Auditee and request authorization to share the Existing Audit Report with the Client. As soon as authorization is received, Qualifyze shall prepare a customized Audit Report for the Client.

The Existing Audit Report and CAPA Plan (if available) shall be submitted to the Client within the timeframes set forth in the applicable General Terms and Conditions and Service Plan, provided that the original Audit Report is already available on Qualifyze’s platform.

As the Audit Report pertains to a previously conducted audit, the copy issued shall be considered a final Audit Report, signed by an authorized representative of Qualifyze, who owns and safeguards the original copy of the Audit Report signed by the Auditor.

This signature confirms that the document is a true, complete, and accurate copy of the Final Report originally prepared and signed by the Auditor, issued specifically for the Client’s use.

No Client-specific requirements may be incorporated into the Existing Audit Report unless such aspects were already addressed during the original audit, as the audit has already been executed.

The Existing Audit Report will be made available through Qualifyze’s online platform. The Client shall receive a notification when the report becomes available.

8. Corrective and Preventive Action Plan

Following the issuance of the final Audit Report, if any observations have been raised during the audit, Qualifyze shall urge the Auditee to submit a Corrective and Preventive Action Plan (“CAPA Plan”) within thirty (30) working days of receipt of the final Audit Report.

The CAPA Plan shall be based on an appropriate root cause analysis and shall address the criticality of each finding with adequate actions and defined implementation timelines. CAPA Plan´s follow-up shall be conducted exclusively for formal observations and shall not apply to remarks or comments.

It is the Auditee’s responsibility to develop the CAPA Plan and ensure that each audit finding is properly addressed. Qualifyze shall review the proposed CAPA Plan to assess whether:

a. all findings are appropriately addressed;

b. the proposed actions are adequate, justified, and proportionate to the severity of the findings;

c. the proposed timelines are reasonable and aligned with regulatory expectations.

If the CAPA Plan submitted by the Auditee is considered inadequate, Qualifyze shall conduct one round of interaction with the Auditee to request any clarifications or revisions necessary to ensure the adequacy of the proposed Corrective and Preventive Actions (“CAPAs”), before sharing the final assessment with the Client.

After the assessment, the CAPA Plan information shall be made available on the Qualifyze’s platform in accordance with the applicable Service Plan.

The outcome of the CAPA Plan evaluation shall be formally communicated to both the Client and the Auditee.

The Auditee is responsible for a timely implementation of the Action Plan according to the established timelines. Qualifyze shall conduct CAPA Plan follow-ups in accordance with the timelines proposed by the Auditee.

In the event of non-submission within the specified period, Qualifyze shall issue reminder notifications to the Auditee every two (2) weeks until receipt of the CAPA Plan or justified cancellation of the follow-up process.

If the Auditee remains unresponsive for approximately four and a half (4.5) months from the issuance of the final Audit Report, Qualifyze shall notify the Client that the CAPA Plan follow-up process will be discontinued within two (2) additional weeks should the lack of response persist.

The CAPA Plan process may be reactivated at any time if the Auditee subsequently provides the required information. The Client shall have continuous access to the CAPA Plan status and updates through Qualifyze’s platform, in accordance with the applicable Service Plan.

Verification of the implementation of actions, their effectiveness, or closure of findings may be performed by Qualifyze during a follow-up audit, if requested by the Client.

A formal statement declaring the closure of the CAPA follow-up shall be issued by Qualifyze when no further updates are expected from the Auditee.

Following the issuance of this closure statement, any additional clarification or information required from the Auditee shall be addressed directly between the Client and the Auditee.

9. Documentation and Information

Audit Reports and supporting documentation shall be made available to the Client for inspection and to competent authorities upon request.

Notwithstanding the foregoing, the Client shall provide Qualifyze with reasonable prior written notice of any request for disclosure to competent authorities or inspection bodies, to enable Qualifyze to notify the Auditee accordingly.

The Auditee may request that disclosure be limited to the information expressly required by the competent authority or the inspection body.

10. Amendments

Qualifyze reserves the right to modify or amend this QTC at any time. Qualifyze shall provide prior written notice to the Client at least fifteen (15) days before the effectiveness of any such modification.

The Client’s continued use of the Audit Services after the effective date of any modification shall constitute acceptance of the modified QTC.

Qualifyze shall not be required to provide prior notice where the modifications are necessary to comply with applicable laws, regulatory requirements, or updates to applicable audit standards, but shall provide notice when reasonably possible.