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Labcompliance News, February 2002

Feb 06, 2002

PIC/S Draft "Good Practices for Computerized Systems in Regulated Environments" Available for Comments

This 53 page guidance document was released by the Pharmaceutical Inspection Convention for comments to relevant international industry associations and industry associations of PIC/S member authorities on 28 January 2002. Individual firms, which would like to comment, must direct their comments to their respective industry associations for collation. National and international industry associations are invited to send their consolidated comments to the e-mail address of the PIC/S Secretariat by 30 June 2002 at the latest.

The purpose of the final guidance will be to provide recommendations and background information concerning computerized systems that will be of assistance to inspectors for training purposes and during inspections for computerized systems. Once final, it is also intended as a reference for related users, including their suppliers, in addition to regulatory inspectors and investigators. The guidance document makes references to GAMP4 and has suggestions for further readings. Ludwig Huber's book entitled "Validation of Computerized Analytical Systems" is one of them and the only one related to laboratories.

Feb 05, 2002

Warning Letter for Part 11 Deviations of a Compliant System

This new warning letter clearly demonstrates that part 11 applies to all electronic records that are used in support of FDA documentation. The FDA inspected a company's computer based complaint system and found out that electronic records did not meet requirements of part 11. Citations have been related to validation, inaccurate and incomplete copies, no protection of records, access to the system not limited. (W-068). Labcompliance user club members can pre-study keywords and extracts and download warning letters. To preview extracts and ordering users club membership, click here and select W-068