Graphic: PENSA Technology Solutions Inc.

Graphic: PENSA Technology Solutions Inc.
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PENSA provides innovative software solutions for the regulated industry.

With many years of experience in the regulated industry, PENSA is aware of the challenges in meeting the ever-stringent regulations. The Compliance Tools offered by PENSA tackle many of the difficult issues in the industry.

Driven by the requirements identified by our knowledgable service consultants, the development team follows a system development methodology to ensure that our final products are of the high quality demanded by our industry.

PENSA Products include the following:

PENSA's Service Pack Compliance Document Kits

To get the most ROI from your licensed software investments, and to remain compliant with the FDA's "General Practices for Software Validation" you can now purchase PENSA's Service Pack Compliance Document Kit (SPCDK). Kits are available for PeopleSoft ERP (formerly JD Edwards ERP) and soon for Agile PLM systems.

The SPCDK is a low-priced way to meet FDA requirements without delaying the implementation of software updates due to validation concerns. The choice is yours: Apply the SPCDK validation yourself, or engage PENSA's experienced team (at additional cost).

SPCDKs are available for:

  • PeopleSoft Enterprise and EnterpriseOne ERP

  • JD Edwards' World and OneWorld ERP

  • Agile PLM

  • or a customized SPCDK for any application.

    Inquire to for more information.

    (Software vendors may also contact us to discuss how we can customize a Service Pack for your application

The Validation Manager (TVM)
PENSA's compliance software designed to create and maintain validation projects electronically. Version 4.6 is now available... (more info)

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.

Vendor Qualification Auditing (VQA)
PENSA's Vendor Qualification Audit (VQA) Program is a product for software vendors working in the Life Sciences sector (pharmaceutical, medical device, biotech). The VQA program allows software vendors to ensure that their development process meets the strict requirements of the industry. (more info)

To request more detailed information, please e-mail

Artificial knee joint image © Zimmer Inc. Used by permission only.

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