Computerized systems validation audits

The validation was performed according to the Roche Computerized System Validation Policy and Guidelines. This comprised the definition of a Validation Plan, the performance of the planned activities, and the creation of a Validation Report. In addition, the project was accompanied by external consultants providing knowhow regarding the validation-specific aspects of the development, including the management and auditing of the software developer. The scope of the validation activities was defined by GMP Analysis (also known as a GMP Assessment). The system... 

Systems audits in computerized systems validation (CSV) are closely related to data collection and management, statistics and pharmacovigilance, as these areas are fully dependent on operating validated and properly functioning systems. 

Validation of computer systems—The role of QA is of particular importance with respect to complying with Part 11, related to electronic records and computer validation. Clinical QA must ensure that any computerized system associated with a study is adequately validated and that the documentation for that validation is concise, complete, and available for audit. Clinical QA must provide the appropriate guidance to both the validation and information technology groups to ensure that clinical studies are not invalidated because of inadequately validated software or hardware. 

For computerized systems, risk-based validations are available that cover access controls (data security), audit trails, viewing the data formats, recovery, handling in case of failure, backup and archiving, data integrity. 

An important objective of ongoing evaluation is to uphold an auditable system of validation documentation and ensure a controlled, fully documented record of any activity that may affect the validation status of the computer system and the computerized operation it is part of. 

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