1. â1âGAMP® 5âA Risk-based Approach to Compliant GxP Computerized Systems. ISPE. 2008. ISBN 1-931879-61-3.
2. â2âGeneral Principles of Software Validation; Final Guidance for Industry and FDA Staff. U.S. Department of Health and Human Services - Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. http://www.fda.gov/cdrh/comp/guidance/938.pdf. January 2002.
3. â3âValidation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation. PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-Operation Scheme. http://www.picscheme.org/publis/recommandations/PI%20006-3%20Recommendation%20on%20Validation%20Master%20Plan.pdf. 25 September 2007.
4. â4âGood Practices for Computerised Systems in Regulated âGxPâ Environments. PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-Operation Scheme. PI 011-3 http://www.picscheme.org/publis/recommandations/PI%20011-3%20Recommendation%20on%20Computerised%20Systems.pdf. 25 September 2007.
5. â5â21 CFR Part 11 Electronic Records; Electronic Signature, Final Rule. Department of Health and Human Services - Food and Drug Administration. http://www.fda.gov/ora/compliance_ref/part11/FRs/background/pt11finr.pdf. March 1997.