Edition
9, November 2006
With the dynamic Life Sciences industry,
there's always information to bring to your attention through this
regular newsletter which is published 2-4 times a year. Subscribe here!
Included
in this issue:
What's New at PENSA
Links
Industry News
Launched
in 1994 with the vision to be the leading provider of a quality
standard within the Life Sciences marketplace that surpasses ISO 9000,
PENSA Technology Solutions Inc. strives to deliver innovative
information technology solutions that meet or exceed worldwide
regulated and quality standards using quality-engineering methods.
Remember
that PENSA's services and products, including The
Validation Manager software application are geared toward
meeting system compliance with:
Enterprise Resource Planning (ERP)
Laboratory Information Management Systems (LIMS)
Change Management Systems
Documentation Management Systems (DMS)
Manufacturing Execution Systems (MES)
Weigh Dispense Systems
CAPA Solutions
process and lab equipment and manufacturing processes, and now Sarbanes-Oxley compliance.
In addition, PENSA offers custom training for a variety of Quality and
Computer Validation subjects. Check the website for complete course
descriptions. Courses and Training
What's
new at PENSA? (Page Up)
November 2006 - New product: PENSAssure™
Building
on our success with The
Validation Manager™(TVM), our software
package for automating and managing computer system validation, PENSA
developers are working on an exciting new product, PENSAssure™.
Adding to the features and functionality provided by TVM, PENSAssure™ is
designed as a powerful tool for compliance, regulatory, quality and
other accountable company directors, managers and supervisors. PENSAssure™will
assist in not only providing a repository of the governing regulations,
be they GMP, SOX, ISO, etc., but will also be the mechanism for
managing and demonstrating a company's compliance with the applicable
specific rules. This will be of particular value during regulatory
body, corporate and other audits.
Look
out for the launch of the exciting new product PENSAssure™ in
early 2007.
November 2006- PENSA now offering
IT Support service options for local businesses
Businesses in the Rideau-St. Lawrence area of Ontario can now avail of
the skills and knowledge of PENSA's IT specialists to provide general
and project-related IT support.
June 2006- The Validation Manager
v4.6 is now available.
PENSA
has been working long and hard to get this newest and most versatile
version of their validation software commercially available. It
includes some new features that have been keenly sought by our clients.
They asked and we delivered features like work flow capability,
embedded objects (which might be images or policy/procedure documents),
live test capture. Take a look at the TVM
details on the website for complete information and then
contact us to arrange a web demo.
Links (Page
Up)
Industry
News (Page Up)
21
CFR Part 11 Electronic Records, Electronic
Signatures
FDA continue to review this contentious regulation. The promised date
for the rewrite has moved from 2005 to late 2006. There is still time
for FDA to meet the latter deadline, but don't be surprised if the new
version is not amongst your hoped for Christmas gifts!
In the interim, the August 2003 Guidance Document on Part 11 Scope and
Application with its emphasis on predicate rules continues to be the
benchmark. Tony Dunbar, PENSA Senior Compliance Specialist, recently
presented a webinar entitled Complying with 21 CFR -
Understanding the Role of Predicate Rules. A recording of the
webinar is available from ComplianceOnline
*Some
content is taken from the following websites: www.fda.gov,
www.fdanews.com
Any
questions or comments regarding this newsletter or about PENSA can be
directed to: the
Editor
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