Guideline

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Good Practices for Computerised Systems in Regulated "GXP" Environments (PI 011-3) Sept 2007
Short Title:	PIC/S PI 011-3
Internet:	http://www.picscheme.org/publis/recommandations/PI-3Recommendation 4520240nomputerised ystems.pdf
Origin/Publisher:	Secretariat of the Pharmaceutical Inspection Convention c/o EFTA Secretariat 9-11, rue de Varembé, CH - 1211 Geneva 20, http://www.picscheme.org
Content:	It is acknowledged that the field of computer technology continues to develop at a considerable speed and the regulated user has to ensure that the software has been developed to best software engineering practices in a quality assured manner. This document sheds some light on the techniques and controls required for this.
Document Type:	PIC/s Guidance