TOPIC: CSV– CSA – GAMP – DI (Computer System Validation, Comp Soft Assurance, Good Automated Manufacturing Practices, Data Integrity)
Computer software assurance is a risk-based approach for establishing and maintaining confidence that software is fit for its intended use. This approach considers the risk of compromised safety and/or quality of the device (should the software fail to perform as intended) to determine the level of assurance effort and activities appropriate to establish confidence in the software. Because the computer software assurance effort is risk-based, it follows a least-burdensome approach, where the burden of validation is no more than necessary to address the risk. Such an approach supports the efficient use of resources, in turn promoting product quality. In addition, computer software assurance establishes and maintains that the software used in production, or the quality system is in a state of control throughout its lifecycle (“validated state”).
By allowing manufacturers to leverage principles such as risk-based testing, unscripted testing, continuous performance monitoring, and data monitoring, as well as validation activities performed by other entities (e.g., developers, suppliers), the computer software assurance approach provides flexibility and agility in helping to assure that the software maintains a validated state consistent with 21 CFR 820.70(i). MEDVACON can assist you and your company with integrating this approach into your CSV methodology.
