RAMP (Risk Assessment and Management Process): An Approach to Risk-Based Computer System Validation and Part 11 Compliance

Abstract

Risk-based computer system validation is a process many companies developed long before the August 2003 Guidance for Industry document on Part 11 Scope and Application was issued by the US Food and Drug Administration. The main differences between priorexisting risk models and this guidance is the emphasis on patient and product safety, product quality, and record integrity as required in the Part 11 Scope and Application Guidance. When computerized systems are used to collect data on which decisions are made on drug efficacy and patient safety or are used to control the quality of drug during a manufacturing process, the point of focus has to change. This article outlines a consistent and justifiable method for determining the risk of a computerized system with the emphasis on patient and product safety, product quality, and record integrity.

Keywords

Risk assessment Risk Management Part 11 ERES System validation

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References

Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry. Part 11, Electronic Records; Electronic Signatures—Scope and Application. August 2003. Available at: http://www.fda.gov/cder/guidance/5667fnl.htm. Accessed November 1, 2006.

Food and Drug Administration. FDA's Mission Statement. 2005. Available at: http://www.fda.gov/opacom/morechoices/mission.html. Accessed November 1, 2006.

Society of Quality Assurance Computer Validation Initiative Committee. Risk assessment/validation priority setting. Qual Assurance Newsl. 1998;14.

International Society for Pharmaceutical Engineers. Risk-Based Approach to 21 Part CFR Part 11, via www.ispe.org. January 2003. [A six-page white paper on approaching risk assessment; no longer available on their Web site.].

Food and Drug Administration. 21 CFR Part 312, Investigation New Drug Application. Available at: http://www.fda.gov/cder/Offices/DSI/goodClinPractice.htm. Accessed November 1, 2006.

International Conference on Harmonisation. Good Clinical Practice: Consolidated Guideline. Available at: http://www.ich.org/cache/compo/276-254-1.html. Accessed November 1, 2006.

Food and Drug Administration. 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. Available at: http://www.fda.gov/cder/Offices/DSI/regulations.htm. Accessed November 1, 2006.

Food and Drug Administration. 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General. Available at: http://www.fda.gov/cder/dmpq/cgmpregs.htm. Accessed November 1, 2006.

Food and Drug Administration. 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Available at: http://www.fda.gov/cder/dmpq/cgmpregs.htm. Accessed November 1, 2006.

10.

European Union Annex 11. Commission Directive 2003/94/EC, 8 October 2003, Laying Down the Principles and Guidelines of Good Manufacturing Practice in Respect of Medicinal Products for Human Use and Investigational Medicinal Products for Human Use. Replacement of Commission Directive 91/356/EC, 13 June 1991, to Cover Good Manufacturing Practice of Investigational Medicinal Products. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htm. Accessed November 1. 2006.

11.

Food and Drug Administration. 21 CFR Parts 203 Prescription Drug Marketing Act (revised as of 1 April 2006). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart-203. Accessed November 1, 2006.

12.

Food and Drug Administration. 21 CFR Part 11, Electronic Records; Electronic Signatures Final Rule. Federal Register, March 20, 1997. Available at: http://www.fda.gov/cder/Offices/DSI/regulations.htm.