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January 25, 2023
Learn about the shift from Computer System Validation (CSV) to Computer Software Assurance (CSA) and the intent of this transition in approach to...
January 24, 2023
/PRNewswire/ -- The "Introduction to Computer System Validation" training has been added to ResearchAndMarkets.coms offering. Computer system validation has...
November 16, 2022
The ISPE's latest GAMP 5 guidelines steer validation practices for pharma companies to meet the computerized system expectations.
October 11, 2022
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022...
October 11, 2022
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022...
October 5, 2022
Six steps to reducing the time, pain, and expense of the software validation process while maintaining quality and safety.

September 15, 2022
The FDA has issued draft guidance on computer software assurance for computers and automated data processing systems used in medical device production.
July 6, 2022
Emergn Principal Consultant Mario Moreira shared insights on how pharma companies can use the principles of Value, Flow and Quality to shorten drug development timelines and deliver better patient outcomes through improved ways of working.
February 18, 2022
/PRNewswire/ -- The "Computer System Validation for Cloud and COTS Applications" training has been added to ResearchAndMarkets.coms offering. Advancements in...
October 6, 2021
As the FDA finalizes and publishes the Computer Software Assurance (CSA) guidance later this year, companies that have not already started the...