CSV and Documentation

Software Validation

November 29, 2019
Shilpa Desai

Each regulated record (is a GMP record) and should be periodically reviewed
Strong SOP and Work instructions repository covering all working areas
Templates for all documentation, processes – recommended, mandatory

VMP for computer systems – mandatory for all who are regulatory audited and use the same for validation across for computer systems
URS – always to be prepared by the user and then can be used to prepare/compare vendor URS, FS
OQ – should also include for Data handling, storage, backup, archiving, if possible – not mandatory

Validation except IQ should always be the user – for IQ vendor and user, OQ, PQ, TM – with vendor’s assistance by user and Summary report – vendor and user

Not document or do anything more than regulatory required
If user cannot change the data then no electronic audit trail

Data archive, Data backup and Data storage – forever and with detailed documentation
Business continuity – always should be with an alternative – contingency option during non-functioning of software, disaster, downtime, etc.
System uptime, application load – to check periodically – possibly with respective SOPs

To raise a Deviation – to finish the way it was started – store all relevant docs securely and in order of the records
Qualify all hardware and all environments – to avoid high load – have uniform software environment on all users to avoid performance issues, if possible

DQ – Client URS + Vendor URS + Vendor requirements
DS – Design specifications on the basis of which software is designed, may/not include technical details

CSV documentation and execution begins with:

Validation Plan
Validation Protocols
Validation Reports

A comprehensive validation documentation package is generated at the end of successful validation execution.

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