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Labcompliance News, October 1999

Oct 25, 1999

  New edition of the USP published

The United States Phramacopeia published a new edition: USP 24. It is available in Paper and Electronic Format on CD ROM. For ordering see the USP Hommepage: www.usp.org

Oct 17, 1999

US Bill Would Validate Digital Signatures

INFOWORLD has published an article on a new bill, H1714, about using digital signatures. According to the article, the U.S. House Judiciary Committee has approved a bill designed to encourage electronic commerce by recognizing digital signatures as having the same legally binding status as a handwritten signature. If two parties agree to use digital signatures to seal their transaction, the signature cannot be ruled invalid by a state legislature or other lawmaking body. There are similarities to part 11 with respect to definitions and linkage of the signature to the record.

Oct 12, 1999

UK Attempt to Validate DNA Technology

The UK is starting to invest significant effort in relation to the validation of DNA technology. This rapidly developing area is having a revolutionary effect on a host of industrial and regulatory sectors, including healthcare, pharmaceuticals, diagnostics, food and agriculture, pollution abatement and forensic analysis techniques to increase confidence in, and allow inter-comparisons of, the results.

Currently the regulation of DNA test us through accepted practice rather than performance criteria, even in areas where the results are used to make critical judgments, such as healthcare or forensic science. Under the current VAM Program the use of reference materials, as well as proficiency testing schemes are being evaluated to meet the needs of inter-comparability and improved insurance of results. Good progress is being made on the development of a Polymerase Chain Reaction (PCR) reference standard and a patent application covering the design of the reference material has been filled.

Oct 9, 1999

 FDA ORA Guide to Inspections of Quality Systems

This document provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer's compliance with the Quality System Regulation and related regulations. The new inspectional process is known as the "Quality System Inspection Technique" or "QSIT". Field investigators may conduct an

August 99, 57 pages. The guide may be used to get an idea on FDAs approach to inspect quality systems in general

Oct 9,  1999

FDA 483's and Warning Letters Related to Computers

Computer systems and the data created and evaluated on them are subject to FDA inspections. This new site will give examples of 483 observations and warning letters related to computer systems and data.

Oct 9, 1999

New ISO Guide 25

The ISO Guide 25 is being updated. The article gives an overview on what's new and how it will impact analytical laboratories.

Oct 9, 1999

New Article on Internet Resources for Computer Validation

Pharmaceutical Technology, September 1999Rory Budihandojo, Sal Amato, Steve Baldwin, Jack Brinnier, Paul N. D’Eramo, Udo Gorsch, Grant Hodgkins, Ludwig Huber, and Graham Tinsley:
This new multi-author article is a compilation of Internet resources related to computer validation, excluding resources available from FDA. For a collection of resources from FDA, see an earlier article "Computer Validation: Available Document Resources from FDA" in the March 1999 issue of Pharmaceutical Technology. Both the FDA-related and non-FDA-related lists of resources are available on-line

Oct 9, 1999

New Book on Computer Validation from Teri Stokes

The Survive and Thrive Guide to Computer Validation
This is a CEO's or Lab Director's handbook for the practical steps to take for computer validation. Each chapter starts with a summary section for the System Sponsor and then goes to a full discussion aimed at the System Owner an System Validation Team.