Answered By: George micheal | 2 years ago | ||
Planning is the most important part of computer validation. Having a good plan in place with owners, deliverables and check points makes validation easy. A master plan increases the efficiency and consistency of validation and answers the inspector's question: what is your approach towards computer system validation. A master plan is also a requirement of European GMPs. A validation project plan guides validation professionals through the entire validation process from writing specifications to system retirement. However, despite of this importance, the regulated industry is unsure on how to develop and document such planning. |
validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
Sunday, May 24, 2009
what is the meanning of master validation plan & how we take stepwise proceding
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