Edition 8, November 2004
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. Unsubscribe
in this issue:
What's New at PENSA , PENSA
on the Road , Links ,
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
process and lab equipment and manufacturing processes,
and now Sarbanes-Oxley
In addition, PENSA offers custom training for a variety
of Quality and Computer Validation subjects. Check the
website for complete course descriptions. Courses
new at PENSA? (Page Up)
November 2004- The Validation Manager v4.5 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.
November 2004- Company divisions
are well established.
Over the last year, PENSA has been expanding and dividing
into the PENSA Family of Companies. After working through
some growing pains, our satellite offices are becoming
firmly established in their respective locations:
November 2004- The Validation
Body of Knowledge ...ready
for industry review
PENSA, along with a handful of industry experts have
created what they are calling the 'Validation Body of
Knowledge'. This document is modeled after the SWEBOK,
'Software Engineer Body of Knowledge' and is intended
to define the qualifications, knowledge, experience,
training and certifications of validation practitioners
in the regulated industries, something that currently
does not exist.
Based on skills and experience it categorizes industry
experts under titles of General Validation Practitioner,
Computer Validation Specialist, Equipment Validation
Specialist, Cleaning Validation Specialist and Process
Ultimately, the hope is to use this document as a method
of scoring an individual's demonstration and knowledge
of certain skills thought to be important for each category.
The 'Stone Man' version is now available for industry
review. If you would like to download the Validation
Body of Knowledge (in pdf format) please send an email
request to PENSA@GMPs.com,
with 'Validation BOK' in the subject line.
on the Road (Page Up)
As a compliance business partner of Agile
Software Corporation, PENSA attended Agility 2004,
the annual Agile Users Conference held in Orlando, October
As always, Agile hosted an impressive show at the Disney
Swan Resort. While in sunny Florida, some new business
relationships were forged and older ones were refreshed.
Many thanks to our gracious hosts, Agile for another
Also this fall, in late September, PENSA packed up off
to Toronto to the annual one day CVG event (Calibration
and Validation Group
). At the booth PENSA ran a demonstration
of their software application
The Validation Manager v 4.5
, which has just become
available for commercial release. It was received with
enthusiasm in the validation community.
News (Page Up)
Petition Urges Elimination of FDA's Part 11 Rule.
An industry group has filed a citizen's petition urging
the FDA to do away with 21 CFR Part 11, saying laws
passed since the rule was introduced adequately address
issues surrounding the integrity of electronic records
The petition, submitted by the Industry Coalition on
21 CFR Part 11, essentially echoes the stance adopted
in comments made in July by PhRMA.
Others in the industry — most notably consultants who
offer guidance on how to conform to the regulation —
argue that the problems with Part 11 stem less from
the regulation itself and more from companies' desire
to lessen their regulatory burden and from ignorance
on the part of FDA officials.
Some industry organizations, however, have argued that
Part 11 is inhibiting the advancement of technology,
and those arguments appear to have resounded in the
ears of regulators, according to one consultant. (from
FDANews Drug Daily Bulletin, Vol. 1 No.189, Oct. 5,
Cornerstone of cGMP Initiative
is Quality Systems Approach.
Pharmaceutical firms need to start building quality
into their products and eschew the idea that testing
alone can be relied upon to ensure product quality —
that's the overarching philosophy of the FDA's draft
guidance on implementing a quality systems approach
to drug manufacturing.
Described by Center for Drug Evaluation and Research
official David Horowitz as the cornerstone of the FDA's
broad pharmaceutical manufacturing initiative, the quality
systems draft guidance lays out a comprehensive approach
that drugmakers can take to develop robust, modern quality
systems that are fully compliant with the agency's current
good manufacturing practice (cGMP) regulations.
Released as part of the FDA's massive cGMP information
package, the draft guidance is intended to serve as
a bridge between the agency's 1978 good manufacturing
regulations and its current understanding of quality
systems. In addition to spelling out the FDA's philosophy
on quality systems, the guidance is also intended to
further the agency's efforts to harmonize cGMPs with
other widely used quality management systems, such as
ISO 9000, non-U.S. pharmaceutical quality management
regulations and the FDA's medical device quality system
regulation. (from FDANews Drug Daily
Bulletin, Vol. 1, No. 190, Oct. 6, 2004)
Final Report on Drug Manufacturing
The FDA this fall will start using a risk-based approach
for prioritizing site inspections for certain pharmaceutical
products, the agency announced in a final report on
its current good manufacturing practice (cGMP) initiative.
The frequency and/or scope of manufacturing inspections
will be reduced for firms the FDA determines have succeeded
in implementing effective quality systems approaches,
according to the report, which caps the agency's "Pharmaceutical
cGMPs for the 21st Century: A Risk-Based Approach"
initiative launched in August 2002.
"We hope that this approach will create positive
incentives for other firms to implement effective quality
systems at their manufacturing sites," the report
said. (from FDA News, Drug Daily Bulletin,
Vol. 1 No.190, Oct. 6, 2004)
For more information on the initiative, go to the FDA's
website at http://www.fda.gov/cder/gmp/.
*Some content is taken from the following websites: www.fda.gov
or comments regarding this newsletter or about PENSA
can be directed to: the
If you prefer
not to be included in this free and informative newsletter
issued 2-4 times a year, you may unsubscribe