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 [...] Read more
Vetting of Quality Assurance in Pharmaceutical industry 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 [...] Read more
Continuous Integration 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, [...] Read more
CSV and Documentation 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 [...] Read more
Controlled, Cost-effective CSV 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 [...] Read more
Significance of CSV in Life Science Industries & How is CSV approach related to SDLC? 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 [...] Read more
Data integrity and Computer Software Validation (CSV) 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 [...] Read more
Design Specification (DS) and Design Qualification (DQ) 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 […] Read more
Some QA definitions 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 […] Read more
Software from a smaller company v/s. from a branded company 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 […] Read more