Appendix: Pertinent Regulations and Guidances in Electronic Data Use

General interest
Author

Chad Briscoe
Executive Director, Bioanalysis
PRA Health Sciences
11070 Strang Line Road
Lenexa, KS 66221
Phone: 913-345-5706
Fax: 913-345-5710
[email protected]

There are a variety of different regulations, guidances and position papers describing the proper testing and use of electronic systems in regulated bioanalysis. None of them provide a definitive guide to the approach for regulated bioanalysis so it is important to understand many of them and apply best practices to the approach taken in your laboratory. This appendix table will serve as a summary introduction to some of the more significant documents so that you can use this as a guide to begin you own investigation and development of appropriate SOPs.

Document Title Year of most recent revision Governing Authority Category Purpose of Document Website
OECD Draft Advisory Document 16. The Application of GLP Principles to Computerized Systems 2014 Organization for Economic Co-operation and Development (OECD) Regulatory Guidance Validation of computerized systems in GLP environments. www.oecd.org/chemicalsafety/testing/Draft-OECD-GLP-Guidance-Document-computerised-systems.pdf
WHO 2006 Technical Report 937, Annex 4, Appendix 5. Validation of Computerized Systems 2006 World Health Organization (WHO) Expert Report Validation of computerized systems in GMP environments. http://whqlibdoc.who.int/trs/who_trs_937_eng.pdf
Guideline for using electromagnetic records, electronic signatures for application for approval and licensing of drugs 2005 Japanese Ministry of Health, Labour and Welfare (MHLW) Regulatory Guidance Set forth the requirements when applicants use electromagnetic records and electronic signatures in drug submissions for the Japanese Market. http://ecompliance.co.jp/english/Japanese%20ERES%20Guideline.html
Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs 2010 Japanese MHLW Regulatory Guidance Describes the recommended system validation activities for compliance with Japanese regulations concerning drug development and manufacturing. http://www.pmda.go.jp/english/service/pdf/gmp/guideline_for_computerized_systems/20110817.pdf
Good Practices for Computerised Systems in Regulated “GXP” Environments 2007 Pharmaceutical Inspection Convention (PIC/S) Expert Report Provide recommendations and background information concerning computerised systems that will be of assistance to inspectors for training purposes and during the inspection of computerized systems http://www.picscheme.org/pdf/27_pi-011-3-recommendation-on-computerised-systems.pdf
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems 2008 International Society for Pharmaceutical Engineering (ISPE) Regulatory Guidance Industry guidance to achieve compliant computerized systems for GxP applications. http://www.ispe.org/gamp-5
NIST Special Publication 800-30 Revision 1. Guide for Conducting Risk Assessments. Information Security 2012 National Institute of Standards and Technology (NIST) Regulatory Guidance Provide guidance for conducting risk assessments of federal information systems and organizations. http://csrc.nist.gov/publications/nistpubs/800-30-rev1/sp800_30_r1.pdf
USP <621> Chromatography Current United States Pharmacopeia (USP) Monograph Describe basic principles of chromatography including system suitability recommendations. https://mc.usp.org/sites/default/files/documents/GeneralChapterPDFs/621Chromatography.pdf
USP <1058> Analytical Instrument Qualification Current United States Pharmacopeia (USP) Monograph Provide a scientific approach to AIQ as one of the major components required for generating reliable and consistent data. https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c1058.pdf
The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 11: Computerised Systems 2010 European Medicines Agency (EMA) Regulation Describes the European regulations for validating software applications and qualifying IT Infrastructure in GMP applications. http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf
Guidelines for the Validation of Computerised Systems in GLP. 2007 Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT) Regulatory Guidance Provide guidance on the GLP-compliant validation of computerized systems. http://www.bag.admin.ch/anmeldestelle/12828/12832/index.html?lang=en
Guidelines for the Archiving of Electronic Raw Data in a GLP Environment. 2006 Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT) Regulatory Guidance Provide guidance on GLP-compliant archiving of electronic raw data. http://www.bag.admin.ch/anmeldestelle/12828/12832/index.html?lang=en
Guidelines for Change Management and Risk Assessment of Validated Computerized Systems in a GLP Environment 2012 Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT) Regulatory Guidance Provides guidance on the GLP-compliant change management of validated computerized systems http://www.bag.admin.ch/anmeldestelle/12828/12832/index.html?lang=en
Guidelines for the Development and Validation of Spreadsheets 2011 Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT) Regulatory Guidance Provides guidance for a basic strategy for GLP-compliant development and validation of spreadsheets. http://www.bag.admin.ch/anmeldestelle/12828/12832/index.html?lang=en
Guidelines for the management of electronic SOPs in a GLP environment. 2006 Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT) Regulatory Guidance Provide guidance on the application of the OECD’s Principles of Good Laboratory Practice (GLP) to the implementation andmanagement of electronic Standard Operating Procedures (SOPs). http://www.bag.admin.ch/anmeldestelle/12828/12832/index.html?lang=en
Guidelines for the acquisition and processing of electronic raw data in a GLP environment. 2006 Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT) Regulatory Guidance Provide guidance on the GLP-compliant acquisition and processing of electronic raw data. http://www.bag.admin.ch/anmeldestelle/12828/12832/index.html?lang=en
Position Paper 1 – Destroy paper copies 2014 Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT) Position Paper Position paper written to answer whether it is acceptable to destroy paper originals of raw data and related study documentation (excluding the final report), if the image of the paper is captured in an electronic form (e.g. scanned). http://www.bag.admin.ch/anmeldestelle/12828/12832/index.html?lang=en
General Principles of Software Validation; Final Guidance for Industry and FDA Staff 2002 United States Food and Drug Administration (US FDA) Regulatory Guidance Outlines general validation principles that the US FDA considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm
FDA Guidance for Industry: Computerized Systems Used in Clinical Trials 1999 US FDA Regulatory Guidance Addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the US FDA. http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133749.pdf
Title 21– Food And Drugs Chapter I – Food And Drug Administration Department Of Health And Human Services Subchapter A — General. Part 11. Electronic Records; Electronic Signatures 1997 US FDA Regulation Sets forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11
Guidance for Industry. Part 11, Electronic Records; Electronic Signatures —Scope and Application 2003 US FDA Regulatory Guidance Intended to describe the Food and Drug Administration’s (FDA’s) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf