Northern VA Information Provider Launches 12th Publication For Pharmaceutical and Medical Device Industry Executives

Aug 10, 2001, 01:00 ET from FDAnews

    FALLS CHURCH, Va., Aug. 10 /PRNewswire/ -- FDAnews, a leading provider of
 compliance information for companies regulated by the U.S. Food and Drug
 Administration, today announced the launch of Part 11 Compliance Report, the
 first newsletter to focus solely on the critical issues surrounding FDA's
 regulation for electronic records and electronic signatures.  FDA has issued
 complex rules, known as Part 11, stipulating how regulated companies create,
 validate, store, access and change computerized records.
     "Part 11 affects nearly every computer system related to laboratory and
 clinical trials and manufacturing," explained Cynthia A. Carter, president.
 The value of all the systems that need to be brought into compliance with the
 rule runs well into the billions of dollars.
     Subscribers to Part 11 Compliance Report will get:
     1) in-depth reviews and interpretations of FDA's Part 11 rule and
 forthcoming guidance documents so you can avoid expensive changes to systems,
 procedures and documentation
     2) best practices in implementation and real examples of how individual
 companies are tackling specific compliance challenges: electronic submissions,
 user ID codes, data security, data management, audit trails
     3) detailed reports of enforcement activity to learn what FDA is cracking
 down on
     4) exclusive interviews with leading regulators, attorneys, consultants
 and practitioners
     Part 11 Compliance Report is produced by FDAnews, a division of Washington
 Business Information, Inc.  FDAnews also publishes Washington Drug Letter,
 Generic Line, Devices & Diagnostics Letter, Strategic Outsourcing Report, Drug
 Marketing, Europe Drug & Device Report, the FDAnews Daily Bulletin an
 electronic briefing, books, special reports and conferences, and many other
 information services to help pharmaceutical and medical device executives meet
 their regulatory challenges.
     Frequency: Biweekly (24 issues), with email alerts
     Format: Print and electronic
     Price: $627/year
     Editor: Peter Riebling
     For more information contact: FDAnews at 888-838-5578 or 703-538-7600 or
 visit us at:
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