Computer System Validation (CSV) is essential for complying with electronic record and system regulations, such as FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4. The validation process ensures that both new and existing computer systems consistently perform as intended, producing accurate, reliable results and detecting any invalid or altered records.
Determination of which systems need to be validated
Clearly defines what the system should do, along with operational (regulatory) constraints
Validation plan – defines objectives of the validation and approach for maintaining validation status
Analysis of failure scenarios
Clearly defines how the system will look and function for the user to be able to achieve the user requirements.
Documentation showing that the network and infrastructure hardware/software supporting the application system being validated has been installed correctly and is functioning as intended
Installation Qualification (IQ) Scripts and Results – test cases for checking that system has been installed correctly in user environment
Operational Qualification (OQ) Scripts and Results – test cases for checking that system does what it is intended to do in user environment
Performance Qualification (PQ) Scripts and Results – test cases for checking that System does what it is intended to do with trained people following SOPs in the production environment even under worst case conditions
A review of all activities and documents against the Validation Plan
Documents that validation activities are complete and the system is available for intended use.
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