It is critical that all employees are fully aware of, and adhere to, all regulatory compliance requirements. Even though regulatory compliance training is mandatory before the start of any LSO’s IT project, the mandate often stops at the “how” part of the compliance process rather than including the “why.”
The issue assumes greater significance in contract research organizations (CROs)/contract manufacturing organizations (CMOs) and IT service providers. Here, individuals often move from varied and nonregulated industries into LSOs, wherein the lack of “control” over their activities and deliverables can result in noncompliance.
To effectively ensure that critical applications which manage food, drugs, patient and clinical data (GxP applications) comply with industry and government regulations, LSOs must focus on established standards such as Title 21 Code of Federal Regulations (CFR) Part 11 (Electronic Records and Electronic Signatures) in processing electronic data that U.S. FDA predicate rules1 require. They must also maintain good automated manufacturing practices (GAMP) and validate IT applications to comply with industry and mandatory regulation.
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