The pharmaceutical industry, together with contract research and contract manufacturing organizations (CRO and CMO) must work under Good Manufacturing or Laboratory Practice regulations (GMP or GLP) to ensure the safety and quality of pharmaceutical products. Compliance with these mandatory regulations ensures both data quality and data integrity. Over the past 15 years, there have been many data integrity breaches due either to poor data management practices, reliance on paper or deliberate data falsification. In the 1970s when the U.S. GLP and GMP were first issued, records were mainly paper-based. Since then, increased computerization has resulted in new regulations and guidance documents that aid interpretation of GMP for the quality and compliance of computerized data syst

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