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Labcompliance News, November 2002

November 30, 2002

IVT's awards Labcompliance Editor as 'Presenter of the Year'

The Institute of Validation and Technology (IVT) did award Dr. Ludwig Huber, Editor of Labcompliance, as the presenter of the year. The selection has been made by attendees of 225 IVT conferences out of 165 speakers. The award has been presented by Glenn Melvin, president of IVT, during a special awards banquet in the historical Rosegarden ball room of the Hyatt Hotel in Philadelphia. Throughout 2002, Ludwig Huber gave 14 presentations at IVT's conferences in North America, Europe and Japan. As Glenn Melvin said, "Ludwig Huber dominated the scores of all presentations he was presenting at". For more information and photos, clicke here. IVT is the leading global publisher and conference provider for validation and compliance.

November 9, 2002   

FDA's Part 11 Guidance on Electronic Copies for e-Records

The FDA has released the fifth draft guidance on part 11. The purpose of this draft guidance is to describe FDA’s current thinking regarding considerations in meeting the requirement on electronic copies of electronic records of Part 11. A couple of points from the guidance: Electronic copies of electronic records provided to FDA should be accurate and complete, but they do not necessarily have to be in the same file format and on the same media as the original electronic records. The process of making an electronic copy of an electronic record in a file format that differs from the original should be validated. Electronic copies should include an authentication value (hash value or equivalent). FDA should be able to process data. The guide can be downloaded from the FDA website.

November 9, 2002

FDA Draft Guidance for Industry: Handling and Retention of BA and BE Testing Samples

This guidance is intended to aid study sponsors and/or drug manufacturers, contract research organizations (CROs), site management organizations (SMOs), clinical investigators, and independent, third parties regarding the procedure for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies. The guidance highlights (1) how the test article and reference standard for BA and BE studies should be distributed to the testing facilities, (2) how testing facilities should randomly select reserve samples, and (3) how the reserve samples should be retained.

November 1, 2002

New Website for Qualification and Compliance of Networks

Networks are computer systems and should comply with regulations such as 21 CFR Part 11. Main requirements are for qualification and security. This site helps network and IT specialists to comply with regulations. It also helps to improve quality, security, integrity and reliability of applications running on a network with as little effort as possible. The site is organized in a similar way as Labcompliance. Currently there is lot's of free reference material that otherwise is used as conference handouts. The site also has links to tools that are useful for qualification of network infrastructure and validation of applications running on the network. Downloads include checklists, reference articles and presentation material. You may forward this info to your colleges from the IT department.

November 1, 2002

GAMP 4 CD ROM available

The electronic version of the GAMP Guide for Validation of Automated Systems, GAMP 4, is now available for purchase. For more information on GAMP 4 or Electronic or to purchase a copy , visit www.ispe.org