Apply the principles of Software Validation and Computer Systems Validation. Implement the Validation Life Cycle approach to software and computer systems Apply Quality Risk Management techniques. Generate key validation documents such as URS, FDS, VMP, IQ, OQ and PQ. Apply the requirements of 21 CFR part 11 in relation to Electronic Signatures & Records.
3 half-day workshops
Kishore Sharma, Cyber Security Analyst with UL