Tag: pharma software validation

Validating Electronic Records and Signatures in Pharma Systems

Validating Electronic Records and Signatures in Pharma Systems Validating Electronic Records and Signatures in Pharma Systems Electronic Records (ER) and Electronic Signatures (ES) play a central role in modern pharmaceutical quality systems. From batch releases and lab results to training…

Applying GAMP 5 for Risk-Based Computer System Validation in Pharma

Applying GAMP 5 for Risk-Based Computer System Validation in Pharma Applying GAMP 5 for Risk-Based Computer System Validation in Pharma Computer System Validation (CSV) is an essential requirement in the pharmaceutical industry to ensure that systems impacting product quality, safety,…