Erfa-gruppe 23: Medical Device Design Verification Testing

Mechanical test equipment in R&D is typically not developed specifically for the pharmaceutical industry and thus often not compliant with requirements from FDA and other authorities.

Purpose

The overall purpose of erfa group 23 is for members to meet and discuss challenges concerning test and test equipment validation, share experience to get a common understanding of requirements and practical solutions to comply with requirements.

The basic assumption is that the group members are the experts, with the best and most applicable knowledge and experience within the field.

It is our ambition that the network group becomes your personal space, where you can test ideas with likeminded professionals.

Topics

FDA and other regulatory authorities’ requirements to Design Verification Testing in R&D, with key focus on requirements to the test equipment

Risk level and the required controls, compared to e.g. equipment that measures the drug before shipment

Timing of DVT testing and criticality of different tests

Practical solutions regarding e.g. 21 CFR part 11, audit trail, access control and unauthorized access to the test data, separation of duty and limited access to system setup

Join the group here

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