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
4) exclusive interviews with leading regulators, attorneys, consultants
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
Editor: Peter Riebling
For more information contact: FDAnews at 888-838-5578 or 703-538-7600 or
visit us at: http://www.fdanews.com/.
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