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Labcompliance News, September 2002

September 5, 2002

FDA's Part 11 Industry Guidance on Maintenance of Electronic Records

The FDA has released the fourth draft guidance on part 11. The purpose of this guidance is to describe the Food and Drug Administration's (FDA's) current thinking regarding principles and procedures for maintaining electronic records in electronic form. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. The guide can be downloaded from the FDA website. For long term archiving the recommendations in the guidance are based on moving electronic records from one computing environment to another. Electronic records might be migrated through several successive systems during a records retention period. This process must be validated. Labcompliance Userclub Members can download an article entitled: Implementing Electronic Records&Signatures Part 4: Data migration, long term archiving and ready retrieval. This article gives recommendations on how to implement the approach. .

September 1, 2002

FDA Warning on Laboratory Equipment, Records and Spreadsheet Applications

This warning letter from July 2002 went to an analytical laboratory of a college that performs testing for a drug manufacturing firm. Citations include missing or inadequate training documentation, missing validation of test methods, and inadequate calibration and maintenance of equipment. Towards the end of the Warning Letter the FDA also cited missing Part 11 functionality by design and missing functionlity like security, password control, integrity, back-up and audit trail. Labcompliance user club members can pre-study keywords and extracts and download warning letters (select W-081). To preview extracts and ordering users club membership, click here .