Computer System Validation

Quality Assurance
1

Hi Sir,

Can you please provide any Policy/Standard/SOP for cGxP Computer Systems whose scope
can be applies to all Computerized Systems that support any oraganisation cGxP
processes, or create, modify, maintain, archive, retrieve or transmit electronic records
that address serve as a cGxP record.

The purpose of this that Policy/Standard/SOP can cover the requirements for Computerized Systems that impact activities related to current Good Manufacturing Practices (GMP), Good
Laboratory Practices (GLP) and/or Good Clinical Practices (GCP) collectively cGxP or
electronic submissions made to applicable regulatory agencies.

2

@kapil_taneja computer system validation and data integrity is defined in 21CFR part 210 and 211.
I have summarised it in following article.

3

OMCL Guidelines are useful. these guidelines are found in OMCL Network in EDQM Website.

https://www.edqm.eu/medias/fichiers/Validation_of_Computerised_Systems_Core_Document.pdf

4

Hi kapil_taneja

You must refer 21CFR part 11 for Electronic records and signatures and GAMP 5 document details you about the requirements of automation practices and its applicability in pharma industry.

21CFR part 210 & 211is only for current GMP of finished dosage forms but not for CSV and data integrity.

Regards
Abhishek