FAQs

Qualifyze supports pharmaceutical companies with their supplier qualification by providing high-quality audit reports with local auditors and local experience within less than 6 weeks. 

We operate the world’s first online platform for supplier and audits connecting manufacturers, suppliers and auditors. We conduct GxP audits for manufacturers of APIs, Excipients, Packaging, FDFs as well as distributors/shipping companies, software suppliers and many others.

GAMP (Software), GCP (Clinical), GDP (Distribution), GLP (Pre-clinical testing laboratory), GMP (API), GMP (Excipients), GMP (Finished dosages), GMP (Packaging), GMP (Medical device), GMP (Subcontracted laboratory), GMP (Starting materials), GVP (Pharmacovigilance), ISO 9001 and ESG.
Yes, each report made by a Qualifyze auditor includes a declaration of independance.
We have implemented a QMS based on ISO 9001 requirements and we are certified by TüV Süd.
We work with a variety of different customers, from some of the biggest names in the industry, to smaller, family run operations. For confidentiality reasons, however, we can not disclose our current customers without their written consent.
All our auditors are contractors, and therefore freelance and not exclusive to Qualifyze. However, we ensure that all auditors we work with feel supported and part of the team from day 1.
Our auditors are highly experienced professionals from the pharmaceutical industry who have gone through a rigorous screening process to qualify as an auditor for us. Learn more about our auditor qualification process on our Auditor page here.
All reports are personalised to the customer who has requested it. The main information in the final report will be the same, no matter how many customers join the audit, however, around 10% of the report will be specifically related to the customer in question and product/s or services they need audited. We go through several checks before issuing our reports to maintain confidentiality and transparency within the report.
Yes. We will not share any report with any new customers without written authorization from the auditee.
We try to be as flexible as possible to cater to our partners’ needs; in general, we allow our partners to join as an observer for the first audit conducted. If for some reason it is a necessity, we are happy to discuss the idea further and explore this option with you.
The customer can request a non-binding offer through our Account Executives or via our platform. If the customer agrees to the audit terms, he signs the offer and sends it to the AE or uploads it on the platform. In the case of purchasing existing audit reports: the Quality Team checks if the report covers everything the customer needs. If not, the contract is canceled free of charge. If the report covers everything necessary, the Quality Team asks for authorization from the supplier. After that, the audit report is available for download on the platform. The customer then receives an automated email with the link to the download. For audits that need to be scheduled: The Auditbooker Team contacts the supplier and tries to arrange an audit date. The Quality Team checks with the supplier if the requested products can be audited and creates an audit agenda. An auditor is selected, and their CV is sent to the customer. The audit is then performed and afterward, the auditor writes the audit report. Our Quality Team checks this draft and then sends it to the customer. The customer now has one last chance to ask questions or comment on the report. Afterward the report is finalized.
It depends on how long it takes to get the authorization from the supplier, but usually just a few days (5-10 working days).
This will depend on how long it takes to get an audit date. If everything goes smoothly, the audit can be performed in 2 months (however, it takes six weeks to finish the draft report).
Yes, it is possible. But it is more expensive for the customer since we have to cover all our costs with one sale agreement.
Quality is an integral part of our company culture here at Qualifyze, both what we deliver to our stakeholders as well as our internal Quality culture. Learn more about how we ensure quality on our Quality page here.
The most suitable auditor is selected based on the site location, audit scope and number of products, auditor qualification, expertise, and availability. All our auditors are highly experienced professionals from the pharmaceutical industry who have gone through a rigorous screening process to qualify as an auditor for us. Learn more about our auditor qualification process on our Auditor page here.
If an important update happens to your audit, you will receive an automatic email from our platform informing you. If you want to see the real-time status of your audits, you can simply log in to our platform and choose one of your audits to view its status.
If an important update happens to your audit, you will receive an automatic email from our platform informing you. If you want to see the real-time status of your audits, you can simply log in to our platform and choose one of your audits to view its status.
For new audits, the answer is yes. Log in to our platform and select the audit that you want to leave a comment in. If the draft report is available in the Overview folder, you will see a blue button labeled “Review draft report”. Click on this button and submit your review. You have 14 days from receiving your draft report to add comments or observations.
Log in to our platform and enter into the audit that you want to upload documents for. Then, click the “Documents” folder and upload all relevant documents pertaining to your audit.
Yes, log in to our platform, enter into the audit that you want to add the PO number to, and then enter into the “Billing” folder. Here, enter the PO number in the “Purchase order number” field and click “Save changes” just below this field. It’s essential to add the PO number as soon as possible before we send the invoice.
No, this is not required. It is only necessary when the auditee or our customers request it.
It depends. For new audits, the final report takes up to 6 weeks after the draft report has been reviewed. For an existing report, the final report can take up to 10 days after the auditee authorizes to share the audit report, and sends all documentation to Qualifyze.
No. It is possible for new or planned audits. For existing audit reports, however, there is no draft report, as the report is already done. So, after you receive the report, you will have to contact us if you have any doubts or comments.
When it comes to new and planned audits, once the “draft report” is available on the platform, the invoice is issued. For existing audits on our platform, once the “report” is available on the platform, the invoice is issued.
This document aims to make the Audit preparation process agile and personalized. This makes it highly beneficial to fill this document to communicate with us any specific requirements for New Audits such as Distributor names (if available), any Quality Agreements in place with the Supplier, etc.
No. Since our business model is based on a Shared Audit approach, we cannot share the audit agenda, as it includes confidential information.
Yes, as soon as you sign the contract, you have access to your auditors CV. You can also then dowload it under the “Documents” tab.
Product, auditee name, audit standard, auditee address, point of contact if available, distributor address and point of contact is all required to schedule a date,
Please fill in your user profile (name, company address, billing address, billing invoice(s) and EU VAT nº (in case your country is located in Europe).
There is a text field in your user view, where you can fill in any requirments you have for this audit.
A filled in information sheet, CAPA plan, COA’s, QAA, old report is possible, any other information relevant to the product/auditee
Yes, but only upon request and authorization of the auditee.
We always ask for an Action Plan when uploading the final report, however, we cannot guarantee a CAPA plan as this depends on the auditee.
We usually ask for an Action Plan, once the final report has been uploaded. We follow up on the Action Plan one month after, after which we send reminders every two weeks. The uploading of the CAPA depends on when we receive the CAPA.
We aim to deliver a draft report within 30 days post-audit.