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Resources for Additional Guidance on Data Integrity

Quick Guide to FDA Part 11 Compliance (Source: The FDA Group)

Understanding Data Integrity for Particle Counters Deployed in Regulated Industries (Source: Climet)

Code of Federal Regulations Title 21 (Source: U.S. FDA)

Guidance Doc: Part 11, Electronic Records; Electronic Signatures - Scope and Application (Source: U.S. FDA)

Guidance Doc: Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry (U.S. FDA)

The Rules Governing Medicinal Products in the European Union; Volume 4: Good Manufacturing Practice Medicinal Products for Human and Veterinary Use; Annex 11: Computerized Systems (Source: European Commission, Health and Consumers Directorate-General)

Guidance on Good Manufacturing Practice and Good Distribution Practice: Questions and Answers on Data Integrity (Source: European Medicines Agency, Science Medicines Health)

Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (Source: Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-Operation Scheme)

‘GXP’ Data Integrity Guidance and Definitions [Source: Medicines & Healthcare Products Regulatory Agency (MHRA)]

BPIT provides clarity on data integrity (Source: BioPhorum)