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CSV and Documentation
- 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.
