Computer System Validation
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages.
Global regulatory bodies (as part of their commitment to expedite & speed-up the treatment approvals) promote submission of Manufacturing, clinical trials and all other associated data through electronic submissions.
It is a requirement that the submitted data meets ALCOA + so that the decisions are made quicker. (Accurate, Legible, Contemporaneous, Original, Attributable + Complete)
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines.
A wide variety of procedures, processes, and activities need to be validated in this process.
Reasons for Validation:
Critical Steps of a CSV
CRQA would help you in developing and implementing CSV:
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