FAQs

What is Qualifyze?

Qualifyze supports healthcare companies with their supplier qualification by providing high-quality audit reports with local auditors and local experience within less than six weeks.
We operate the world’s first online platform for supplier audits, connecting manufacturers, suppliers, and auditors. We conduct GxP audits for manufacturers of APIs, Excipients, Packaging, and FDFs, as well as distributors/shipping companies, software suppliers, and many more.

What kind of audits do you conduct?

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.

Can you provide a Declaration of Auditor Independence?

Yes, each report made by a Qualifyze auditor includes a declaration of independance.

What are your certifications?

We have implemented a QMS based on ISO 9001 requirements and we are certified by TüV Süd.

Who are Qualifyze's current customers?

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.

Are your auditors employed by Qualifyze or contracted as freelancers?

The majority of our auditors are freelancers that collaborate with us on-demand, whenever we have an audit that fits their expertise, language and/or geographical location. We also have highly qualified auditors in our internal Quality team that conduct audits for our customers. In both cases, all auditors we assign follow our Qualifyze methodology when conducting their audits, and work under the directives defined in our QMS. They are also part of the same qualification and supervision process, ensuring all auditors, whether in-house or external, are all held to the same high-quality standards.

Who are the Qualifyze auditors?

Our auditors are highly experienced professionals from the pharmaceutical and healthcare industries 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.

How personalized are the reports?

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 the product/s or service/s they need audited. We go through several checks before issuing our reports to maintain confidentiality and transparency within the report.

We don't want to share our audit for confidentiality reasons; can you do this for us?

Yes. We will not share any report with any new customers without written authorization from the auditee.

Can we join as co-auditors?

We try to be as flexible as possible to cater to our partners’ needs; in general, we allow our partners to join as observers 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.

What is the audit process like?

The customer can request a non-binding offer through our Account Executives or 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.

How long does it take to receive an existing audit report?

It depends on how long it takes to get the authorization from the supplier, but usually just a few days (5-10 working days).

How long does it take to receive the audit report if the audit is yet to be performed?

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).

Is there also the possibility to have an exclusive audit performed?

Yes, it is possible. But it is more expensive for the customer since we have to cover all our costs with one sale agreement.

How do you ensure quality?

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.

How do you select the auditors?

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 healthcare 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.

How will I track my Audits?

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 log in to our platform and choose one of your audits to view its status.

How will I get updating on my Audit?

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.

Can I add comments to the Draft Report?

For new audits, the answer is yes. Log in to our platform and select the audit in which you want to comment. 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.

Where can I upload/Download documents in my audit in the platform?

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.

Can I add a Purhcase Order (PO) number to my invoice?

Yes, log in to our platform, navigate to the audit to which you want to add the PO number, and then navigate into the “Billing” folder. Enter the PO number in the “Purchase order number” field and click “Save changes” below this field. It’s essential to add the PO number as soon as possible before we send the invoice.

Do I need to sign a CDA or NDA with Qualifyze/Auditee?

No, this is not required. It is only necessary when the auditee or our customers request it.

Once signed the contract, how long does it take to have the final report?

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.

For existing audit can I add comments in the report before it is done?

No. It is possible for new or planned audits. However, there is no draft report for existing audit reports, 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 will I receive the invoice?

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.

Why do I need to fill up the Information Sheet?

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.

Do we receive an audit agenda?

No. Since our business model is based on a Shared Audit approach, we cannot share the audit agenda, as it includes confidential information.

Do we have access to the auditor CV?

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.

What information do I need to include in the platform to schedule a date?

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.

I have registered on the platform, now what?

Please fill in your user profile (name, company address, billing address, billing invoice(s), and EU VAT nº (if your country is located in Europe).

I want to focus on a specific topic during an audit, where can I state that?

There is a text field in your user view where you can fill in any requirements necessary for your audit.

What information does Qualifyze need for audit preperation

A filled-in information sheet, CAPA plan, COAs, QAA, a previous report (if available), and any other information relevant to the product/auditee.

Can we share the report with our CMO/client

Yes, but only upon request and authorization of the auditee.

Do we receive CAPAs?

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.

When do we receive the CAPA?

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.

When will I receive a Draft Report?

We aim to deliver a draft report within 30 days post-audit.

What is a shared audit?

Shared audits are planned audits that combine multiple customer requests into one audit. When we combine multiple customers into one audit, we can execute various “audits” simultaneously. We do this by extending the audit scope, meaning more products are audited in one audit. That means instead of trying to execute multiple audits across multiple days, we can save the auditees time and resources by rolling them all into one audit event.

What is an existing audit report?

Recently published audit reports executed by us on behalf of one or multiple clients. These audit reports are active and ready to purchase directly from our platform, making them ideal for customers with last-minute audit needs. It’s our most efficient and cost-effective audit service. With hundreds of audit reports in our database, we likely have the existing audit report you’re looking for.

What audit standards do we work with?

Will Qualifyze sell the report without our knowledge?

No, you must give us written permission for every report we sell to additional customers who were not part of the original audit. We will never share any information without your express consent. Transparency with our stakeholders is one of our core values.

What information will be displayed on your platform?

We will only display your name, the site’s location, audit standard, and audit date. All other information will only be available to the customer after you have approved their admission to the audit.

Is there a confidentiality agreement in place with your customers?

Yes, all our customers agree to our confidentiality terms and conditions when we sign the contract. If required from your side, we can also facilitate a 2-way or 3-way CDA signature process.

Does Qualifyze charge us for an audit scope extension?

No, Qualifyze will never charge you for our service. We will always remain independent, but a scope extension benefits all parties.

Will you need more time if we extend the audit scope?

We always try to respect the previously agreed audit time frame. This depends, however, on how many additional products will be audited. If need be, we may need to consider a different audit date.

How can we cover more products within the same time frame?

By using a systematic approach, meaning we audit one product from every workshop. Those products can then be used as an exemplary product and allow us to include other products manufactured under the same QMS and in the same workshop.

Will I have to conduct audits outside my country/region?

At Qualifyze, we try to work with local auditors. This helps us to avoid last-minute changes due to travel restrictions and allows audits, where possible, to be conducted in local languages to help facilitate smoother communication between auditors and auditees. In this sense, in most cases, you will be offered audits in your own country or region.

What is the standard volume of audits allocated to each auditor?

We understand that an auditor can only carry out about one audit per week. That means the workload would be between 1 and 4 audits per month, depending on the auditor’s suitable experience and the volume of audits.

How will I be compensated?

When discussions begin around audit details with the auditor, a general rate for one-day audits is agreed upon, as well as a special fee for every additional day. These fees consider the preparation, execution, report writing, and review process.

Are expenses covered by Qualifyze?

Qualifyze covers all costs incurred during the audit execution as long as they are reasonable and directly connected with the audit. Specific guidelines for expenses are agreed upon when signing the contract.

Which criteria is it used to allocate auditors?

The most suitable auditor is allocated based on the site location, audit profitability, auditor qualification, expertise, and availability.

What are the steps to become a qualified auditor?

The first step is to upload your CV here. If your CV meets our minimum requirements, you will complete a questionnaire to give us a more detailed overview of your experience. After that, you will be invited to an interview to evaluate personal behavior and communication skills, verify information provided in the SAQ, test knowledge in auditing, and acquire additional information if needed. In the last step, you will need to provide a redacted sample audit report from a previous audit experience. Once all this information has been collected, a final assessment will be made to confirm your qualifications and the areas for which you will be qualified. For more detailed information about the auditor application process, please visit our Auditor page here.