Quality and Regulatory Sourcebook March 2022
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Contextualizing Computer Validation
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Contextualizing Computer Validation
Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology, Regulatory Sourcebook, March 2022
Volume 2022 eBook
Issue 1
Pages: 16-18
Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape.
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Computer system validation (CSV), also known as software validation, is required by regulatory agencies throughout the development timeline. Pharmaceutical Technology 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 Pharmaceutical Technology'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
Pharmaceutical Technology eBook: Quality and Regulatory Sourcebook, March 2022 Pages: 16-18
Citation
When referring to this article, please cite it as G. Playter, “Contextualizing Computer Validation," Pharmaceutical Technology's Quality and Regulatory Sourcebook eBook (March 2022).
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Common FDA 483 Observations for Combination Products
Facilitating Biopharma Continuous Manufacturing
In-Use Testing of Cleanroom Garments
How a Lack of Critical Thinking is Hindering Regulatory Compliance
A Method Validation Framework for Combination Products
Contextualizing Computer Validation
Supply Chain Considerations for Ensuring Quality
DSCSA’s Next Big Hurdle
Remote Inspections - Lessons Learned
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