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Labcompliance News, March 2001

March 21, 2001

Update on FDA's Part 11 compliance policy guides

The FDA has established a website with information on part 11 compliance
Currently you can find topics for guidance documents which are: archiving,
audit trails, electronic copies for FDA, glossary, time stamps and
validation. The contents may be reviewed at FDA's Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061,
Rockville, MD 20852. The office is open to the public between 9 a.m. and 4
p.m., Monday through Friday.

March 05, 2001

New article: Electronic Signatures and Records in Practice

From L.Huber. The paper gives on overview on requirements of FDA's 21 CFR Part 11 and provides high level information for implementation. Topics are validation, secure retention and retrieval of accurate and complete copies, limited access to systems and data and binding handwritten and e-signatures to records. The article has been published in Pharmaceutical Canada, Vol 1, Number 1, 18/22.

March 05, 2001

FDA releases program for device manufacturer inspections

The FDA has released the final compliance program CP 7382.845 for Inspection of Medical Device Manufacturers. The program includes guidance for determining compliance with the Quality System/Good manufacturing Practices Regulation (QS/GMP) regulation, Medical Device Reporting (MDR) regulation, Medical Device Tracking regulation, Corrective and Removal regulation, and the Registration and Listing regulation. The document includes a model warning letter with examples of deficiency.