What is CSA?
In a GMP environment, patient safety, data integrity and product
quality are of utmost importance. Computerised operations are under
highest regulatory scrutiny: both FDA and EU GMP guidelines
stipulate the need to validate processes, systems and software
which replaces manual operations
Since the introduction of the CSV Guideline in 2011, the
regulatory bodies require validation of computerised systems (CSV)
to assure patient safety and product quality, and they require full
documentation, audit trails and scripted testing as proof.
It is expected that in 2021 a new FDA guidance will be released
on this subject, concerning Computer Software Assurance (CSA),
where the focus is more on the electronic systems and the software
used. This new FDA guidance aims to minimize misinterpretation of
regulations, to clarify existing approaches, to increase the
possibility of technology innovation and to introduce a risk-based
approach to software testing & comp
