Contextualizing Computer Validation

Computer system validation (CSV), also known as software validation, is required by regulatory agencies throughout the development timeline. BioPharm International reached out to various experts associated with the FDA-Industry Computer Software Assurance (FISCA) team to discuss computer validation and add context to the ongoing discussion surrounding its use and importance in the greater regulatory landscape.

Read this article in BioPharm International’s March 2022 Quality and Regulatory Sourcebook eBook.

About the author

Grant Playter is the Assistant Editor for Pharmaceutical Technology, BioPharm International, and Pharmaceutical Technology Europe.

Article Details

BioPharm International eBook: Quality and Regulatory Sourcebook, March 2022 Pages: 8-9, 36

Citation

When referring to this article, please cite it as G. Playter, “Contextualizing Computer Validation," BioPharm International Quality and Regulatory Sourcebook eBook (March 2022).