Computer System Validation (CSV)

System Validation | Compliance | Quality | Life Sciences

Computer System Validation(CSV) ensures accuracy, reliability, and consistent intended performance of the system. CSV has the ability to separate out the invalid or altered records which is a critical requirement of electronic record compliance, as described in the 21CFR part 11.10(a) and EMA Annex 11, Section 4. CSV is the process of documenting that a computer system meets a set of defined system requirements. Pharmaceutical computer system validation is a unique opportunity for businesses to examine their computer systems to maximize effectiveness and enhance quality.

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