Graphic: PENSA Technology Solutions Inc.

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Graphic: PENSA Pipeline
Edition 4, April 2003

Welcome to the fourth edition of the PENSApipeline newsletter. With the ever-changing Life Sciences industry, there's always lots of information to bring to your attention through this regular newsletter which is published twice a year.

Included in this issue: PENSA's recent Award, Release of Version 4.0 of The Validation Manager software tool, PENSA at the J.D. Edwards Users Conference coming in June, a synopsis of the recent and ongoing industry trends.

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.


What's New at PENSA

Award Winning
November 2002. PENSA wins the Brockville Chamber of Commerce Bell Canada New Technology Award, in recognition of their innovative software; The Validation Manager, used by our FDA-regulated clients to simplify the arduous task of computer system validation- an FDA requirement. We'd like to thank the Brockville Chamber of Commerce for this recognition.

New Products to launch.
Version 3.9 of The Validation Manager is currently available. Installations of the tool on site at two industry giants planned for late April.

PENSA is preparing to launch version 4.0 of The Validation Manager and in-house testing of this software tool will begin in the near future. Version 4.0 of TVM will have enhancements including:

  • Familiar Microsoft Windows style navigation. Now there's drag and drop capability and Spell Check built right in.
  • The linking feature and the traceability report is strengthened so that users can have an 'error only' view and there's a generalized linking capability for non-validation applications.
  • We've added an area for test results. Schedule tests for execution, enter specs and even capture an image directly into the application.
  • Part 11 security has more flexibility with customizable features like sequencing of required signatures and overwriting. Data entry into fields will require signatures and TVM will log failed attempts at sign-on and object approval- all part of a solid audit defense.

If you aren't familiar with PENSA's revolutionary software application, The Validation Manager (TVM) designed to help automate and manage validation projects, please visit the website for more information...Click Here

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PENSA on the Road

Quest Global Conference, Denver, June 9-12 2003.
As the only Validation partner selected by J.D. Edwards for their OneWorld Life Science clients, PENSA is pleased to be delivering a seminar at the annual J.D. Edwards users conference Quest Global Conference (formerly, FOCUS) entitled "Competitive Compliance: Using Software Tools to Automate the Compliance Process". Please join us there. ( If you've never been to this users conference, it is worth attending. It's a very informative couple of days packed with perks and freebies in a beautiful city.)

Barnett International Conference on Electronic Signatures and Electronic Records, Philadelphia, June 26-27 2003.
The focus of the conference will be on the new FDA initiatives regarding Part 11. Some of the things to be covered will deal with defining a "risk-based" approach, identifying critical systems, and assessing the impact of the changes on existing Part 11 programs. PENSA will be delivering a presentation: "The Evolution of Automated Tools to Manage Competitive Risk-Based Compliance". (as yet, the Barnett website does not appear to have updated the conference calendar to include this, but keep checking the above link) 

Remember that PENSA's services and products including The Validation Manager are geared toward the validation of software for Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), Change Management Systems, Documentation Management Systems (DMS), Manufacturing Execution Systems (MES), Weigh Dispense Systems and CAPA Solutions. In addition, we offer on site or in-house training, on Quality and Computer Validation subjects as well as Training Tracking Software, and Electronic Logbook Software. 

PENSA consultants remain up to date with industry changes and trends and we pride ourselves on that. We are aware of the latest guidance documents, new policies and new interpretations. That kind of industry knowledge is valuable to our clients and also transferable to our clients through PENSA's products and services.

If you have doubt about the compliance of a system or piece of equipment in your regulated environment, contact PENSA for an audit, and we'll see how it measures up.

For a full description of products and services please have a look at the PENSA website www.GMPs.com or contact the general email PENSA@GMPs.com, and your inquiry will be promptly addressed by the correct people.

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FDA Facts

Summer 2002, the FDA altered the way it enforces GMP requirements by shifting responsibility for Part 11 enforcement from the Office of Regulatory Affairs to the Center for Drug Evaluation and Research (CDER). The FDA's new GMP program - part of a trend toward a risk-management approach - could take two years to implement fully, according to John Taylor, director of the agency's Office of Enforcement.

MEDICAL INDUSTRY E-MAIL NEWS SERVICE (TM) -- NOV. 12, 2002 -- In an eye-opening revelation, the highly-respected US Government Accounting Office (GAO) claims in a landmark study, that for 8 years, FDA officials chose to award annual pay increases to all FDA employees -- instead of fulfilling its requirements to inspect medical product manufacturing facilities. In addition, reviews of over-the-counter pharmaceuticals and generic products were sacrificed, in order to pay themselves more money. The entire study has been published in Biomedical Market Newsletter, which requires a subscription.

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Recent News from the Industry

October 2002, Pharmaceutical cGMPs for the 21st Century: A Risk Based Approach (paraphrased from "FDA Launches Major Review of cGMPs" in Pharmaceutical Technology, by Jill Wechsler). In August, FDA Deputy Commissioner Lester Crawford announced a high-profile initiative to reevaluate cGMP policies that have been in place for 25 years. The revision is based on long running comments (and complaints) from the industry and aims to get FDA policies up to speed with modern technology, encourage new manufacturing technologies, develop more consistency with FDA policies. The whole reappraisal process is expected to take two years.

November 14, 2002. FDA PLEDGES TOUGH CONSENT DECREE REINSPECTIONS
The FDA will rigorously investigate and prosecute violations of consent decree provisions to the full extent of the law, an agency attorney warned corporate lawyers at a Nov. 12 Food and Drug Law Institute conference on enforcement and litigation issues held in Washington, D.C. Disgorgement of profits from products made by companies in violation can cost millions of dollars. However, "money is the least of the problems" facing a company when consent decree errors or violations are in question, said Eric Blumberg, deputy chief for litigation in FDA's Office of the Chief Counsel. "When we get there for an inspection, you're already on the treadmill," he said. The agency also will not issue multiple warning letters when consent decree provisions are not being met, Blumberg said.

February 3, 2003. FDA WITHDRAWS ELECTRONIC COPIES GUIDANCE
The FDA will withdraw its November 2002 21 CFR Part 11 ecopies guidance because it no longer represents the agency's approach under its new good manufacturing practice (GMP) initiative. The FDA may decide to reissue the guidance after it has reviewed it under the initiative. For more information, follow this link.

February 21, 2003. FDA PLANS SWEEPING CHANGES TO GMP RULES
The FDA announced yet another set of initiatives to take the agency closer to its goal of creating a risk-based approach to good manufacturing practices (GMPs) for drug companies. The FDA plans to have a more detailed risk model in place by fiscal 2004 that will help the agency predict where its inspections would most likely have the greatest impact, Center for Drug Evaluation and Research Director Janet Woodcock said at a teleconference yesterday unveiling the plan. For more information, follow this link.

March 3, 2003. GMP INSPECTION TEAMS MAY INCLUDE MORE SPECIALISTS
As part of its initiative to update the rules on good manufacturing practices (GMPs), the FDA may beef up its drug plant inspection teams by adding more product and technical specialists to help it perform more thorough and consistent inspections. The specialists would have scientific expertise in research, technology and compliance, the FDA's Working Group on Product Specialists on Inspection Teams proposed in a new report. To see the report, follow this link.

March 7, 2003. FDA WILL INSPECT 'HIGH-RISK' DRUGMAKERS EVERY 2 YEARS
The FDA plans to inspect drug manufacturers it deems "high risk" at least every two years under its new risk-based approach to GMP enforcement, according to agency officials. The agency aims to examine 55 percent of the "high-risk" firms this fiscal year, said David Horowitz, director of the Office of Compliance for the Center for Drug Evaluation and Research. For the current fiscal year, the FDA has identified three types of firms as "high risk": nonmedical gas prescription drug manufacturers, sterile drug manufacturers and new registrants not previously inspected.

April 18, 2003. ISO 14971 TO BECOME WORLDWIDE RISK MANAGEMENT STANDARD. ISO 14971 is the best path toward worldwide compliance with risk management requirements, several industry experts said. By next April, ISO 14971 will be the only standard for devices to meet risk analysis and risk assessment benchmarks in the European Union (E.U.). ISO 14971 runs parallel to the Quality System Regulation (QSR) with regard to risk management and includes post-production review, according to Alfred Dolan, chairman of the Joint Working Group on Risk Management. He also said that ISO 14971 is being integrated into every technical standard for medical devices.

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Links

  • More as a matter of personal interest but somewhat related to the Life Sciences Industry, I came across a website that lists all American product recalls, not just drug products, called Safety Alerts. (interesting to browse)
  • FDA Warning Letters in a searchable database
  • The very informative 21 CFR Part 11 website keeps up to date with industry developments in this area

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News from Partners

Q1-2003, PENSA becomes the official compliance partner of Agile, a Document Management Solution Provider. Agile recognizes PENSA as a premier computer system compliance-consulting firm capable of ensuring that Agile's products are properly validated by employing its professional staff and extensive documentation library. PENSA plans to work hand-in-hand with Agile, its Sales Team and customers to provide FDA regulatory expertise and compliance services.

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Industry Feedback

February 2003. Withdrawal of the FDA Guidance document issued November 2002 concerning '21 CFR Part 11, Electronic Signatures and Electronic Records' for re-assessment. The FDA remains adamant that Part 11 is not going away, just that it will soon reflect a 'kinder and gentler approach'. The agency will accept comments on the withdrawal until April 28th, before issuing final guidance on its next steps. For more information, go to: http://www.fda.gov/cber/gdlns/prt11elect.pdf

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*Contents taken from the following websites: www.fda.gov, and www.fdanews.com, and the Biomedical News Online newsletter.

Any questions or comments regarding this newsletter or about PENSA can be directed to: Erica_Charlton@GMPs.com

If, for any reason you prefer not to be included in this informative newsletter issued twice yearly, you can unsubscribe here.

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