Resources and Tools - GxP Compliance

RELATED LINKS

Guidelines-for-Establishing-Good-Research-Practices-in-Research-Laboratories.pdf
Guidelines-for-Good-Research-Practices-in-Research-Laboratories-Conducting-Sample-Analysis-in-Support-of-a-Clinical-Trial.pdf
21 CFR 11: Electronic Records; Electronic Signatures
Guideline for Electronic Signatures in Human Subject Research During COVID-19 Pandemic
FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application
FDA Guidance for Industry: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11
FDA Guidance for Industry: Electronic Source Data in Clinical Investigations
FDA Guidance for Industry: Use of Electronic Informed Consent Questions and Answers
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations
FDA Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations
General Principles of Software Validation; Final Guidance for Industry and FDA Staff
EudraLex Annex 11: Computerised Systems
PIC/S Guidance: Good Practices for Computerised Systems in regulated GXP Environments
PIC/S Guidance: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

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