Fast dive into csv


Insights and Experience from Computer System Validation

Some time ago I was asked to participate in a Quality Remediation Project being executed by a leading Medical Device Company, a customer of ours. Together with two redtoo CSV experts I joined into a larger project team of about twenty Computer System Validation specialists responsible to retrospectively validate according to GAMP5© computer systems for equipment used in Production. A similar team of specialists working in the US formed together with us one of several work streams in this global customer project. The Master Validation Plan for the project reflected the retrospective approach by a shortened V model allowing us to focus on the most important aspects and respective documents to get the job done in time. The three of us have been working for about eight months in seven different sites in Switzerland. For a couple of months a fourth colleague from redtoo filled a gap as well. Covering all respective equipment in these seven sites gave us a wide variety of systems to be validated. The four of us validated more than 80 systems, where each validation project required at least twelve different documents which all had to go through a three level approval process. A good number of systems was excluded from validation by a defined set of rules. However, this also required at least two approved documents for each such system. Overall the four of us created more than thousand documents within this project, which all went through the formal approval process.

Amongst the systems covered there were 3D coordinate measuring systems (various models from Zeiss, Mitutoyo, Conturomatic and others), an optical axle measurement system, video microscopes, packaging machines (Autobag,  Power packer, Inauen, Tecnimodern), hardness testers, a spring tester, a safety and functional tester for electric products (Power Tools), laser etching machines (mainly Trumpf and Foba), a CNC based engraving system, material testing devices to perform oscillating tests of material for instruments and implants, 3D printers, a surface measuring system (roughness/waviness profile depth), a chamber steam sterilizer and several cleaning systems (Dürr Minio) to mention the most important ones.

All of us used the many opportunities to learn more about Production and equipment in Production. This helped us to further broaden and deepen our expertise. Our broad experience on the other hand allowed us to successfully and significantly contribute to the success of the work stream and the project. Cooperation with people from Production was especially fruitful and enjoyable.

written by Otto Salecker

Dominated by the logic of mathematics, driven by passion, fascinated by the unknown and emotion, equipped with tons of experience, gone through many fires, always…

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