That GMP training exams make an excellent proof of personnel competency?
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.
Especially for Blood / Biologics
FDA 21 CFR Part 11 and Predicate Rules:
What You Need to Know
By David Ade
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
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
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.
(Institute of Validation Technology Conference)
Jan. 23-25, 2007
Drug Delivery Partnerships
Jan. 22-24, 2007
Las Vegas, NV
Lean Six Sigma
for Medical Device
Jan. 31-Feb. 2, 2007
20th Annual DIA Conference for Electronic Document Management
Feb. 6-9, 2007
Quality Systems for Pharmaceuticals / Biopharmaceuticals
Feb. 7-8, 2007
Feb. 12-15, 2007
MEDTEC Exhibition & Conference
Feb. 14-15, 2007
NEC, Birmingham, UK
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