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PIC/S Good Practices for Computerised Systems in Regulated "GXP" Environments (PI 011-3) Sept 2007

Short Title:
PIC/S PI 011-3
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

Document Type:
PIC/s Guidance
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.

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