Computer system validation (CSV) is the process of documenting that a computer system meets a set of defined system requirements.
It provides a suitable approach to compliance with all types of computer systems, according to national and international regulations.
Pharmaceutical computer system validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality.
Reference Guidelines: FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4.
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