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Labcompliance News, July 2001

July 25, 2001

Q&A's on 21 CFR Part 11 with Paul Motise

Some time ago Paul Motise answered questions from the UK Supplier Forum on 21 CFR Part 11. The same and similar questions are also frequently asked on discussion forums so we thought to put the Q&A's on the Labcompliance Website.. Some keywords: instrument control parameters and part 11, extension of durable media to battery backed-up memory and flash disc technologies, part 11 and temporary temperature profile of an autoclave

July 11, 2001

New FDA Draft Guideline on Mass Spectrometry

The draft is entitled "Mass Spectrometry for Confirmation of the Identity of Animal drag Residues". It has been issued by FDA's Center of Medicine. This draft document is intended to provide specific guidance for the development, evaluation, and application of mass spectrometric methods for confirming the identity of animal drug residues. It represents the current thinking of the FDA Center for Veterinary Medicine on the performance standards that qualitative mass spectrometry should meet for regulatory purposes. The guidance is intended to apply to consultations on confirmatory methodology, desk reviews of confirmatory procedures, method trials or second-laboratory evaluations of confirmatory procedures, development of confirmation procedures and desk reviews of data generated with confirmatory procedures.

July 11, 2001

New Warning Letters on 21 CFR Part 11

In the first seven months of 2001 the United States FDA has issued several Warning Letter related to 21 CFR Part11. Key issues have been insufficient security, inadequate validation of computer systems and missing audit trail functionality. Two Warning Letters resulted from inspections of networked systems. Cited deficiencies have been missing audit trail function of the data base and inadequate validation and documentation of network programs. These include program code, functional/structural design, diagrams, specifications and text descriptions of other programs that interfere with (this program). For more citations and links for downloading the Warning Letters, click here. In response to FDA's increased attention to networks, Labcompliance has developed a network quality package

July 11, 2001

ISO/IEC 17025 Gap Analysis

The National Association of Testing Authority (NATA), Australia, has developed a 24 page gap analysis worksheet for the new laboratory accreditation standard ISO/IEC 17025: General requirements for the competence of calibration and testing laboratories. The worksheet lists key requirements of the standard. A nice feature is that the differences to ISO Guide 25 are written in bold which makes it easy for Guide 25 accredited laboratories to identify gaps to the new standard.

July 11, 2001

The impact of 21 CFR Part 11 on Global Manufacturing and Product Safety

This article from John Blanchard of ARC Advisory Group analyzes the impact of 21 CFR Part 11 on Electronic Batch Record (EBR) Systems. It gives four recommendations on how to achieve compliance with part 11 for suppliers and users while reducing the Total Cost of Ownership (TCO).