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:
NEW!
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 PENSA@PENSA.ca
for more information.
(Software vendors may also
contact us to discuss how we can customize a
Service Pack for your application PENSA@PENSA.ca)
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 PENSA@PENSA.ca.
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