21 CFR Part 11 Compliance.com

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Installation and operational qualification are important steps in the overall validation and qualification process of software and computer systems. FRMS validation package comes complete with test scripts, IQ, OQ and PQ templates that will guide you through the validation steps required during installation and tests required prior to operation; processes called installation qualification and operational qualification, or acceptance testing. The purpose of OQ is to demonstrate that the system’s hardware and software operate 'as intended' in the user's environment.

FRMS Validation Documentation Templates   
 -  Test scripts 
 -  Installation Qualifications (IQ)
 -  Operational Qualifications (OQ) or acceptance testing.
 -  Performance Qualifications (PQ)

 

 

 

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