Learn How To Think Like The FDA ®
“Established since 1999”
REGULATORY COMPLIANCE SERVICES
The Food and Drug Administration (FDA) has increased its attention on data integrity and taken regulatory and enforcement actions against regulated companies. The Agency's mission in consumer protection is being impacted since the information it receives from regulated companies in some cases is not trustworthy. The accuracy, reliability, and general trustworthiness of data is a broad concept and applicable to areas other than computer system validation (CSV) and electronic records/electronic signatures (21 CFR Part 11).
GCGI’s Data Integrity support services are systems-oriented. Within this system, there are three (3) subsystems that can be thought of as gears: Validated State, Human Performance Technology (HPT) and Requirements Traceability.
Energizing these gears are four catalysts:
These gears and catalysts provide firms with an outcomes-based, data-driven, top-down GMP system that supports regulatory requirements. Experience has shown that by making regulations work to firms’ advantage, many companies have increased productivity and improved product quality while decreasing expensive rework.
GCGI’s Consulting, Auditing and Training services provides the required knowledge to put into action the four catalysts. Understanding how these subsystems work together allows firms to fully integrate data integrity principles into daily GMP laboratory activities.