(1) US Food and Drug Administration,Guidance for Industry: Good Manufacturing Practices for the 21st Century(FDA, Rockville, Maryland, 2002).

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(2) International Conference on Harmonization,ICH Q9, Quality Risk Management(ICH, Geneva, Switzerland, 2008).

(3) General Chapter <1058> "Analytical Instrument Qualification" inUnited States Pharmacopeia 36 –National Formulary 31(United States Pharmacopeial Convention, Rockville, Maryland, 2012).

(4) ISPE,Good Automated Manufacturing Practice (GAMP) Guide, version 5(International Society of Pharmaceutical Engineering, Tampa, Florida, 2008).

(5) ISPE,GAMP Good Practice Guide Validation of Laboratory Computerized Systems, 1st Edition(International Society of Pharmaceutical Engineering, Tampa, Florida, 2005).

(6) ISPE,GAMP Good Practice Guide: A Risk Based Validation of Laboratory Computerized Systems, 2nd Edition(International Society of Pharmaceutical Engineering, Tampa, Florida, 2012).

(7) R.D. McDowall,Spectroscopy25(11), 24–29 (2010).

(8) Current Good Manufacturing Practice Regulations for Finished Pharmaceutical Goods, in21 CFR211.68(b) (U.S. Government Printing Office, Washington, DC, 2008).

(9) US Food and Drug Administration,Guidance for Industry,General Principles of Software Validation(FDA, Rockville, Maryland, 2002).

(10) R.D. McDowall,Spectroscopy26(12), 14–17 (2012).

(11) Proposed revision toUnited States Pharmacopeia<1058> Analytical Instrument Qualification inUnited States Pharmacopeia(United States Pharmacopeial Convention, Rockville, Maryland, 2013).

(12) L. Schuessler, M.E. Newton, P. Smith, C. Burgess, and R.D. McDowall,Pharm. Tech., in press.

(13) C. Burgess and R.D. McDowall,Pharmacopeial Forum38(1), 2012.

(14) Computer Validation Initiative Committee of the Society of Quality Assurance,Computer Risk Assessment(Society of Quality Assurance, Charlottesville, Virginia, circa 1997).

(15) ISPE,GAMP Good Practice Guide, A Risk Based Approach to Compliant Electronic Records and Signatures, (International Society of Pharmaceutical Engineering, Tampa, Florida, 2005).

(16) R.D. McDowall,Quality Assurance Journal12,64–78 (2009).

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