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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 here!

Included in this issue:

What's New at PENSA , PENSA on the Road , 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 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:

  • PENSA Technology Solutions Inc. North American Head Office, Brockville, Ontario.
  • PENSA Validation Services Inc. Brockville, Ontario
  • Meachar Toronto, Ontario
  • PENSA Technology Solutions USA, virtual offices in TX and CT
  • PENSA Technology Solutions Ltd. based in the United Kingdom.

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 Validation Specialist.

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, with 'Validation BOK' in the subject line.

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PENSA on the Road (Page Up)

October 2004

As a compliance business partner of Agile Software Corporation, PENSA attended Agility 2004, the annual Agile Users Conference held in Orlando, October 10-13.

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 successful event.

September 2004
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.

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Links (Page Up)

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Industry News (Page Up)

Citizen's 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 and data.

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, 2004)

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 Regulations Issued.
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
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