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DID YOU KNOW...

That GMP training exams make an excellent proof of personnel competency?
Full Story


Especially for Pharmaceuticals

If you're looking to improve a single area in your FDA compliance program, look no further than your quality control unit. Full Story

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Especially for Pharmaceuticals



Especially for Medical Devices

Quality audit is one of the most common pitfalls for medical device firms during inspections. Full Story

Additional Articles:
Especially for Medical Devices



Especially for Blood / Biologics

What’s CAP accreditation got to do with FDA compliance? Considered one of the strictest standards today for clinical labs, CAP could serve as a shot in the arm for your FDA compliance initiatives.
Full Story

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Especially for Blood / Biologics



FDA 21 CFR Part 11 and Predicate Rules:
What You Need to Know
By David Ade

Ten years after the FDA issued 21 CFR Part 11, the agency is expected to issue a new guidance for compliance, even as it considers revising the regulation.

Hailed as a landmark rule back in 1997, FDA 21 CFR Part 11 (also commonly known as 21 CFR 11 or Part 11) made electronic records and signatures as valid as paper records and handwritten signatures. It allowed the use of electronic record-keeping systems in complying with predicate rules. However, it did not take long before the praises for 21 CFR 11 turned into criticisms. The regulation was causing so much confusion, especially on what it covered and how the FDA should enforce it.

After much discussion from all sides and endless speculation all these years, this much is certain: Part 11 is here to stay. “The regulation won’t go away. However, while we won’t rescind it, we may revise it,” said Janet Woodcock, FDA deputy commissioner for operations, in an interview with BIO-IT World. Read more.


How to Solve the Top Five Document Management Challenges

Document management is such a fundamental need in any FDA compliance effort, and it poses so many challenges, that we could easily discuss the “top 20” or more problems that plague life science companies. But in the interest of space, here are the top five document control issues that most companies complain about and some tips on solving them.

1. Inefficient Routing and Tracking. Sure, walking is healthy, but legwork as a means of routing and tracking documents critical to FDA compliance is simply inefficient. Imagine a sprawling manufacturing site with several buildings that house hundreds of people who work different shifts 24/7. Routing a document change request form, for example, would mean walking from one building to another in a race against the clock to catch a certain person during his or her shift. Tracking the form would require twice the effort. Granting that this form can be routed via e-mail, the possibility that it might get buried in someone’s “in” box remains. Read more.

Upcoming Events

Change Control
(Institute of Validation Technology Conference)

Jan. 23-25, 2007
Washington, D.C.
www.ivthome.com


Drug Delivery Partnerships
Jan. 22-24, 2007
Las Vegas, NV
www.iirusa.com



Lean Six Sigma
for Medical Device

Jan. 31-Feb. 2, 2007
Philadelphia, PA
www.marcusevans.com


20th Annual DIA Conference for Electronic Document Management
Feb. 6-9, 2007
Philadelphia, PA
www.diahome.org



Quality Systems for Pharmaceuticals / Biopharmaceuticals
Feb. 7-8, 2007
Jackson, FL
www.pharmaconference.com


MDM West
Feb. 12-15, 2007
Anaheim, CA
www.devicelink.com


MEDTEC Exhibition & Conference
Feb. 14-15, 2007
NEC, Birmingham, UK
www.devicelink.com

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Editorial Staff

GxP Lifeline
is published once a month by MasterControl Inc.
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Web site: www.mastercontrol.com

Publisher: Curt Porritt
Executive Editor: Jason Clegg
Editor: Cindy Fazzi
Design: Mike Hansen

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