Be audited by Qualifyze and save time, energy and resources
Do you want to minimize the time you spend co-ordinating audits for your customers? Let us schedule dates, liaise between stakeholders, and combine multiple customer audits into one.
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How we work
Audits are an important part of your business. But they don’t have to cause unnecessary headaches. Here, we make the audit process simple and straightforward. Forget about coordinating between multiple customers across multiple dates. Let our auditee team support your audit requirements and take the heavy lifting off your hands.
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Shared audit model
All our audits are offered as shared audits. This lets us save time, energy and resources for you (the auditee). This means that once an audit has been planned, multiple customers can join the same audit. As an auditee, you retain full control over the approval process for every single customer that requests to join an audit.
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Finding a date
We can be very flexible and reactive when it comes to booking the audit date that best suits you. This is possible thanks to our large network of local-language speaking auditors worldwide. Once we have a timeframe from our customers, we can get to work finding a date that works for you, your customer and the auditor.
After setting a date for the audit, here’s what we’ll do next:
Want to learn about our selection process for our auditors? Click here.
- We request the documents we need from you, depending on the audit standard and customer requirements.
- 6-8 weeks before the audit, we collect final feedback from the customer.
- We begin creating the audit agenda. It requires sign off from both your customer, and you, before being finalized.
- 4-6 weeks before the audit, we introduce you to our selected auditor.
Want to learn about our selection process for our auditors? Click here.
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The audit has been completed. What’s next?
- 4 weeks after being audited, you’ll receive your draft report.
- You and your customer then have 2 weeks to come back with feedback or questions. After this, we finalize your report.
- We centralize any CAPA findings, which means we become your one point of contact for CAPA follow ups, no matter how many customers were participating in your audit.
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Shared audits, individualized reports
Each of your customers will only see the product they’ve audited you for. This is why we prepare individual reports for each client. Each one of them will only see their name and company information in their final report, no matter how many customers were part of the audit.
RESELLING YOUR REPORT
Once we have the final audit report, we’ll ask you if we can display the audit on our platform to resell it to future customers. We’ll only do it if we receive your approval. If you give us your consent, we’ll only publish the name of the auditee, the site, and the date the audit was carried out.
If someone wants to buy the report, we will ask you again for your consent. We can also sign a CDA if required. No other information is accessible until we have your consent to resell the report, and a contract is signed with our customer. In short, nothing happens without your approval.
The Qualifyze way
For anything you need related to audits, our auditee account management team is here to support you. Whether you need help with executing an audit for one customer, or optimizing your audit lifecycle and streamlining the amount of audits you conduct every year, we’re here to find solutions that save you time and energy.
By working with Qualifyze as a recognized and competent certifier, we have so far been able to cover 30% of our customers' audit requests. The transparent presentation of our processes and safeguards in a targeted audit report is ideal for our pharmaceutical customers to demonstrate compliance with regulatory and system-technical requirements. With the possibility of this independent and objective assessment, we achieve a high level of acceptance among pharmaceutical customers, because we reduce the time and costs for everyone involved without having to accept a loss of quality in the statements. In addition, we see problem-free support, as well as quick and structured coordination between end customers and our company.
It was such a pleasure partnering with Qualifyze and having Nicole (the selected auditor) visit our site. Our team genuinely enjoyed having Nicole’s company, and felt comfortable with her auditing approach. She was a great auditor and very intuitive, which we appreciate so we can become a better facility and improve our current processes. I also liked the transparency of receiving a list of customers that were represented by Qualifyze leading up to the day of the audit. We appreciate Nicole and the entire Qualifyze team and we certainly look forward to working with Qualifyze again in the future!
The LyondellBasell team was impressed by the in-depth understanding the auditor had of our and our customers business. We saw clearly that the auditor was well prepared and had a good understanding of our process, as well as that of our customer. The questions she asked were important and made sense in the context of the business. Big compliment on how the audit was conducted, Thanks!
Get audited for free
Get prepared and save time, energy and resources by requesting a free-of-charge, proactive audit from us today.
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.
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.
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.
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.
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.
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.
No, Qualifyze will never charge you for our service. We will always remain independent, but a scope extension benefits all parties.
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.
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.