Bioanalysis Zone

Appendix: Pertinent Regulations and Guidances in Electronic Data Use

Author

Chad Briscoe
Executive Director, Bioanalysis
PRA Health Sciences
11070 Strang Line Road
Lenexa, KS 66221
Phone: 913-345-5706
Fax: 913-345-5710
briscoechad@prahs.com

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 TitleYear of most recent revisionGoverning AuthorityCategoryPurpose of DocumentWebsite
OECD Draft Advisory Document 16. The Application of GLP Principles to Computerized Systems2014Organization for Economic Co-operation and Development (OECD)Regulatory GuidanceValidation 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 Systems2006World Health Organization (WHO)Expert ReportValidation 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 drugs2005Japanese Ministry of Health, Labour and Welfare (MHLW)Regulatory GuidanceSet 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-drugs2010Japanese MHLWRegulatory GuidanceDescribes 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” Environments2007Pharmaceutical Inspection Convention (PIC/S)Expert ReportProvide recommendations and background information concerning computerised systems that will be of assistance to inspectors for training purposes and during the inspection of computerized systemshttp://www.picscheme.org/pdf/27_pi-011-3-recommendation-on-computerised-systems.pdf
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems2008International Society for Pharmaceutical Engineering (ISPE)Regulatory GuidanceIndustry 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 Security2012National Institute of Standards and Technology (NIST)Regulatory GuidanceProvide 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> ChromatographyCurrentUnited States Pharmacopeia (USP)MonographDescribe basic principles of chromatography including system suitability recommendations.https://mc.usp.org/sites/default/files/documents/GeneralChapterPDFs/621Chromatography.pdf
USP <1058> Analytical Instrument QualificationCurrentUnited States Pharmacopeia (USP)MonographProvide 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 Systems2010European Medicines Agency (EMA)RegulationDescribes 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.2007Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT)Regulatory GuidanceProvide 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.2006Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT)Regulatory GuidanceProvide 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 Environment2012Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT)Regulatory GuidanceProvides guidance on the GLP-compliant change management of validated computerized systemshttp://www.bag.admin.ch/anmeldestelle/12828/12832/index.html?lang=en
Guidelines for the Development and Validation of Spreadsheets2011Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT)Regulatory GuidanceProvides 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.2006Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT)Regulatory GuidanceProvide 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.2006Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT)Regulatory GuidanceProvide 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 copies2014Swiss Federal Office of Public Health. Working Group on Information Technology (AGIT)Position PaperPosition 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 Staff2002United States Food and Drug Administration (US FDA)Regulatory GuidanceOutlines 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 Trials1999US FDARegulatory GuidanceAddresses 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 Signatures1997US FDARegulationSets 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 Application2003US FDARegulatory GuidanceIntended 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
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