Regulatory agencies inspect manufacturers or processors of regulated products (drugs, devices, diagnostics) to verify that they comply with relevant regulations and expect that the companies retain complete and accurate records, including all raw data, that are available to inspectors during inspections.
Recorded information/data is the basis for manufacturers to assure product identity, strength, purity, and safety. Any non-compliance found in the integrity of data may result in regulatory enforcement action from the agencies.
The FDA “Data Integrity and Compliance With CGMP Guidance for Industry” refers to data integrity as the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate (ALCOA) .
Our Data Integrity practice includes the following services: