pharmaceutical-engineering understanding-computer-software-assurance-csa 
ISPE
APRIL 12, 2023
Paper-Based Validation in Biotech: No Longer a Choice The complexities of biological processes like cell line development, protein expression, and capsid engineering demand extreme precision and thorough documentation for regulatory bodies. The software itself should be easy to implement, use, understand, and scale. 1 Weeks, L.
ISPE
JANUARY 9, 2023
The technical content of the guide has been updated to reflect the increased importance of information technology (IT) service providers including cloud service providers, evolving approaches to software development including incremental and iterative models and methods, and increased use of software tools and automation.
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