Digital Pathology for use in a regulated nonclinical environment is governed by the Food and Drug Administration (FDA) Code of Federal Regulations (CFR) Title 21 part 11: Electronic Records; Electronic Signature and predicate rules associated with Good Laboratory Practices (GLP) documents including 21 CFR part 58.
GLP & CFR
Good Laboratory Practice (GLP), is defined by the Medicines and Healthcare products Regulatory Agency (MHRA) as a set of principles that provides a framework within which studies are planned, performed, monitored, recorded, reported and archived. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment.
US FDA GLP regulations 21 CFR § 58.61 and 58.63(a) state that equipment used in the generation, measurement, or assessment of data shall be of appropriate design and capacity. It also states that it should be adequately tested, calibrated and/or standardized. Furthermore, US FDA regulations for electronic records: electronic signatures 21 CFR § 11.10(a) state that it is necessary to validate a system to ensure accuracy, reliability, consistent intended performance and the ability to discern an invalid or altered record. For more information on validation please refer to the DPA white paper, “Validation of a Digital Pathology System in the Regulated Non-clinical Environment.”
- MHRA website: GLP Background Information
- Good Laboratory Practices (GLP) documents including 21 CFR part 58.
- Code of Federal Regulations (CFR) Title 21 part 11
- Pharmaceutical Administration and Regulations in Japan
- International Conference on Harmonisation Guidelines