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    Qualifyze GmbH

    German-based Qualifyze is a specialist in end-to-end global GxP and sustainability auditing, having pioneered the first global online compliance reporting platform.

    The Qualifyze platform allows pharmaceutical and life sciences companies to revolutionize the ways in which they manage and optimize their audit workload and provide their customers with higher quality reports.

    Vision & Mission

    Qualifyze was founded in understanding that the life sciences supply chain audit process has become too complex for many companies to manage efficiently, with multiple departments sending audit agendas, information sheets, and other supporting documents back and forth via email. Furthermore, third-party audit services are often expensive and have unpredictable fees not disclosed at the point of purchase. It is difficult for pharmaceutical companies to predict their expenditure on supplier audits, with the bulk of outgoings spent on international travel and expenses.

    The Qualifyze  mission is to build the trust layer for global supply chains with a user-friendly platform focused on data-sharing from unified and verified sources that allows  multiple stakeholders to view, track and manage their audits in real-time, and that also offers a simple, consistent, and all-inclusive pricing model.

    Activities & Products

    The Qualifyze auditing platform allows companies to search for their suppliers, input the product / services they need auditing and instantly receive a quote. From here onwards, they can confirm their interest, download the auditors’ curriculum vitae (CV), upload information sheets, download draft / final reports and submit corrective and preventive action (CAPA) plans once the audit takes place.

    The platform provides clients with access to an extensive network of qualified auditors. It further allows them to request supplier audits in just a few clicks, enabling the tracking of 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.

    Qualifyze now offers more than 800 shared GxP audits that allow multiple companies to join the same audit, and currently performs more than 420 new audits annually. 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.

    A global network of highly experienced auditors, allows Qualifyze to execute audits in any location, handling all steps, from customer pre-approval to CAPA management.

    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.

    The company provides dedicated support channels for auditees, auditors and customers, with every customer receiving a dedicated account manager and multiple language support.

    Company History and Structure

    Qualifyze (formerly ChemSquare) was founded in September 2017 as the result of a Ph.D. program at the Technical University of Darmstadt, with a guiding mission to be the facilitator for all stakeholders in the auditing process, to reduce the efforts and resources expended on activities that make no actual contribution to end product safety and sustainability.

    Since then the company has become the first global online platform for supplier audits that connects pharma companies, suppliers, and auditors. Headquartered in Frankfurt am Main, Qualifyze also has a Spanish subsidiary based in Barcelona.

    In July 2019, Qualifyze launched its digital audit platform and has since seen exponential growth backed through two funding rounds, receiving almost $5.6m.

    During 2021, Qualifyze trebled the number of employees to more than 90 people, all experts within their fields, as well as a network of more than 100 local auditors worldwide.

    In November 2021, Qualifyze secured a further $14 million in additional investor funding from European venture capital.

    Quality, Regulatory and Standards

    Qualifyze is certified by Germany’s TÜV Süd agency to full ISO 9001:2015 quality standards, which govern all its business processes.

    The company’s other main quality priority is its process for auditor selection and qualification, with procedures that are deeply embedded in its internal Quality Management System. The qualification process includes different stages that need to be fully completed by the auditors to become a qualified Qualifyze auditor.

    Do you need to audit one of your suppliers? Join a new audit, purchase an existing, active report or commission a custom audit with Qualifyze and optimise your audit planning processes. Explore our audit database today.

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