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Computer System Validation (CSV) V/S Computer Software Assurance (CSA) – Change is On the Way

April 18, 2022 Team CSV Software Validation

The FDA’s new approach to CSV is Computer Software Assurance (CSA). It represents a step-change in computer system validation, placing [...]

May 7, 2020 Team CSV Software Validation

Pharmaceutical manufacturing is one of the most closed regulated industry. The Pharmaceutical industry have last 50 years of admirable quality [...]

March 16, 2020 Team CSV Software Validation

Continuous integration (CI) is a method of integrating changes needed in one single project which is developed, then tested accordingly, [...]

November 29, 2019 Shilpa Desai Software Validation

Each regulated record (is a GMP record) and should be periodically reviewed Strong SOP and Work instructions repository covering all [...]

June 29, 2019 Shilpa Desai Software Validation

CSV is mandatory for implementation of software systems in a GxP regulated environment. And, it would incur huge costs if [...]

June 16, 2018 Shilpa Desai Software Validation

Computer System Validation (CSV) is the practice of ensuring that any software or hardware which meets its purpose with regulatory [...]

April 24, 2017 Shilpa Desai Software Validation

For any software implemented, regulatories in their audit look for adherence to regulatory and quality standards. These standards would include [...]

September 1, 2016 Shilpa Desai Software Validation

Very “synonymous words”, DS and DQ, and can many a time be misleading, We might want to say one but […]

December 25, 2015 Shilpa Desai Software Validation

Qualification – applies to hardware, devices; not the process in which the hardware is used. Thus, verifies the hardware is […]

October 19, 2015 Shilpa Desai Software Validation

A query… It is a common belief across that the softwares developed by known and established software vendors (with a […]

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