By Qualifyze GmbH
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Qualifyze: a global compliance auditing platform
Since it was founded in 2017, German-based Qualifyze has pursued its mission to perfect the world’s first online platform for supplier audits connecting manufacturers, suppliers, and auditors.
The Qualifyze platform allows pharmaceutical and life sciences companies to revolutionize the ways in which they manage and optimize their audit workload, providing them with higher quality reports in under six weeks.
Qualifyze has now conducted more than 600 GxP audits for manufacturers of APIs, excipients, and FDF finished drug forms, including some of the world’s leading pharma companies, as well as suppliers of packaging, logistics, IT support and others.
Its team now numbers more than 100 people plus an equivalent number of auditors with strong backgrounds in pharma, life science, technology, engineering, and business.
Integrated auditing platform
The Qualifyze platform is focused on a user-friendly interface and data-sharing from unified and verified sources that allows multiple stakeholders to view, track and manage their audits in real-time, while also offering simple, consistent, and all-inclusive pricing model.
The platform allows pharma clients to centralize all their compliance and supplier qualification auditing in one place. It allows multiple users to access and manage audit reports from their desktops, laptops or mobile devices and to order new audits with a few clicks, using the integrated E-signature tool.
It further allows them to track every individual Corrective and Preventive Action (CAPA). By sharing audits with several pharma companies, the audit burden for suppliers is reduced, and the CAPA update to customers is simplified.
Audit owners can check current status and progress in real time just by clicking on the request.
The platform provides clients with access to an extensive global network of more than 110 qualified auditors located in prime pharmaceutical regions worldwide with close understanding of regional guidelines.
Most Qualifyze auditors have specialist pharmaceutical experience and Qualifyze usually manages to pair clients with an auditor with specific relevant experience in that area. The Qualifyze auditing platform allows companies to search auditors by region and specific expertise and to download auditors’ CVs.
Qualifyze recruits auditors by a rigorous five step process that includes interview, checking of previous credentials and feedback, a written test and that is followed by continuous assessment.
Qualifyze auditors receive the necessary equipment and collateral to help them perform audits to a high standard, with report structured to simplify preparation, revision and readability. Each section contains a summary table to efficiently identify risks according to their respective color rating, with findings classified according to their criticality.
Shared GxP audits
Qualifyze now offers more than 650 shared GxP audits that allow multiple companies to join the same audit. Each participating customer receives a customized report, depending on their request, while maintaining confidentiality. These cost-effective audits are increasingly popular, enabling companies to audit small batch suppliers with no need for individual inspections.
Qualifyze audits are designed to be very easy to read and use, featuring a traffic light system that rates compliance performance in each category from red (poor) to green (very good).
Audits do not always cover entire production sites (systematic audit approach), but rather focus on the products or services that our customers receive from the supplier to provide as much relevant detail as possible.
Audits can cover a series of relevant performance areas:
- Quality: quality management system of the supplier and the production of specific products observing standards such as GMP, ISO, FSC, etc
- Environmental: Success in following guidelines for sustainability and environmental protection to identify the company’s impact on the environment
- Social: Compliance with relevant labor rights standards, describing how the respective company is dealing with its people to create fair working conditions
- Health & Safety: Outlining relevant standards for health and safety throughout the supply chain and itemizing how they are met at key locations
Qualifyze offers a choice of audit execution models:
- Onsite Audit: includes physical inspection of the supplier premise by at least one trained and experienced auditor. Based on client expectations, the audit can follow a standard Qualifyze or a client specific methodology. This approach is recommended for new suppliers, critical suppliers as well as suppliers with historically low performance
- Remote Audit: includes inspection of the supplier via digital tools. This inspection is facilitated through video conferencing and document exchange tools. In addition, a virtual factory inspection tour is made possible through the use of smart With auditee approval, the factory tour recording can be shared with clients as a marketing tool
- Benchmarked Self- Assessment: includes a digital questionnaire to be completed by the supplier with results then checked and benchmarked by Qualifyze. Recommended for high-ranking / historically compliant suppliers. In any area where supplier falls short of minimum expectations, an additional onsite audit is recommended
To learn more about Qualifyze and their GxP and sustainability audits, click here