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Labcompliance News, January 2001

Jan 2, 2001

LabCompliance UsersClub with 50% more documents

More and more compliance experts take advantage of the information on the Labcompliance usersclub sites. Registered users can access the sites with personal ID and can view, print and/or download documents. Now the site has been updated with more than 30 new documents. These include standard operating procedures, checklists, publications, FDA warning letters, and slide presentations and interviews with FDA representatives. The warning letters are dedicated to validation and compliance and the new site also includes keywords and extracted text to get information more quickly prior to the download. For more information and links to a preview and registration click here

Jan 2, 2001

New Internet Seminar Series on 21 CFR Part 11


Agilent Technologies will run a series of on-line seminars on how to implement 21 CFR Part 11 in Analytical Laboratories. Contents will include basics of the rule as well advanced topics such as the role of instrument control, biometric devices and data migration strategies for long term archiving and ready retrieval. One seminar will be dedicated to a case study using the Agilent ChemStation as an example. The seminars are free. For exact titles, dates and registrations please visit the Agilent on-line seminar website.

Jan 28, 2001

NARA Releases Guidance for Records Management

The United States National Archives and Records Administration (NARA) has developed this guidance for agencies implementing electronic signature technologies. This was done in response to the Government Paperwork Elimination Act (GPEA). This act requires that, when practicable, Federal agencies use electronic forms, electronic filing, and electronic signatures to conduct official business with the public by 2003. In doing this, agencies will create records with business, legal and, in some cases, historical value. This guidance focuses on records management issues involving records that have been created using electronic signature technology. The guidance uses similar vocabulary as 21 CFR Part 11and addresses some of the same points. Therefore it is a good document to read for part 11 implementation.