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Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper

Implementation and Management of GMP Data Integrity

 

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About The Event

 

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.