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Validation - A Key Requirement
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FDA has defined validation as :
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Established documented evidence which provides a high degree
of assurance that a specific process will
consistentlyproduce a product meeting
its pre-determined specifications and quality attributes.
Validation can be re-stated as a means of proving that the
requirements for a system have been :
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Defined in advance,
and that the system has been tested to prove that these
requirements have been met and proof that each step has been completed
by objective evidence in the form of documentation.
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GAMP : Good Automated Manufacturing Practice is a "How to Guide" for the validation of computer systems. It
contains seperate requirements for suppliers of systems and users of systems. It was developed as each company, and indeed
each project team within a company, tended to apply personal preference rather than a methodology for compliance. GAMP
provides, supplies with a universal standard that would meet the requirements of the pharma industry.
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21 CFR Part - 11 is another requirement if
the validation requirement is not maintained on paper. It can be
summarized as "The final rule that provides criteria under
which FDA will consider electronic records to be equivalent to paper
records andelectronic signatures equivalent to traditional hand
written signatures".
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Validation Life Cycle
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