
Are systems in compliance with ISO 80002-2 if we follow the guidelines described in GAMP5?
Discover whether pharma's computerized system validation applies to non-product medical device software by comparing ISO 80002-2 with GAMP5.
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Senior Consultant Software Services
Jan Appelmans is a Software Specialist at QbD Group, working across Belgium and the Netherlands. With over a decade of hands-on experience in the IVD industry — including 8 years at Biocartis spanning QA, regulatory documentation, system engineering, and platform analysis — Jan brings a deep understanding of medical device software and compliance from both the manufacturer and consulting side. At QbD Group, he helps life science companies navigate software validation, digital compliance, and the transition to electronic IFU.

Discover whether pharma's computerized system validation applies to non-product medical device software by comparing ISO 80002-2 with GAMP5.
Read more
The structured approach to ensure regulatory compliance and proper operation of your computer systems, throughout their life cycle.
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