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Compassoft and Pharmaceutical Services Corporation Team to Offer Regulatory Compliance and Auditing Software to the Life Sciences Industry.


SCOTTS VALLEY, Calif. & PASADENA, Calif. -- Companies in the highly regulated biotech and pharmaceutical industries will benefit from a new alliance announced today between Pharmaceutical Services Corporation (PSC (Public Service Commission) Same as PUC. ) and Compassoft, Inc. The partnership will help these companies manage operational risk and meet worldwide regulatory mandates from the Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) to Sarbanes-Oxley requirements in the US and Asia. Under the terms of the agreement, PSC, a recognized leader in the implementation and validation of enterprise IT solutions in the regulated environments of the life sciences industry, will team with Compassoft, a software leader in the discovery, validation and control of End User Computing Using a desktop or laptop computer.  (EUC EUC Extended Unix Code
EUC Emergency Unemployment Compensation
EUC End User Computing
EUC End User Council
EUC International Conference on Embedded and Ubiquitous Computing (IFIP International Conference)
EUC European Union Center
) applications such as spreadsheets, databases and reports, to distribute, implement, validate and support Compassoft's regulatory compliance and auditing software, including the award-winning Enterprise[TM], EXChecker[TM] and DaCS[TM] product lines.

"This alliance will give more companies around the world access to critical software applications that ensure financial and data accuracy in spreadsheets, databases and reports," said John Clapham Sir John Harold Clapham CBE, LittD, FBA (September 13 1873- March 29 1946) was a British economic historian.

He was educated at The Leys School, Cambridge and was the first Professor of Economic History at Cambridge University from 1928 to 1938, and Vice-Provost of King's
, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Pharmaceutical Services Corporation. "As international compliance consultants offering validation, auditing and technical management services to the life sciences industry it would be impossible to overstate the importance of reducing risk by automating reporting processes for information and data in regulated environments."

Today, financial and IT departments at pharmaceutical companies, large banking establishments, professional services (job) professional services - A department of a supplier providing consultancy and programming manpower for the supplier's products.  firms and other companies across a wide range of industries in the US and overseas are successfully using Compassoft's regulatory and auditing software to discover, audit and control EUC applications to minimize operational risk and to ensure compliance with computerized reporting requirements such as the US FDA's Electronic Records and Electronic Signatures Rule (21 CFR CFR

See: Cost and Freight
 Part 11) and Section 404 of the US Security and Exchange Commission's (SEC's) Sarbanes-Oxley Act See SOX.  mandating internal controls.

"PSC is a growing IT consulting firm with new offices in Asia and a deep expertise in databases and spreadsheets for the biotech and pharmaceutical industries so it is an ideal partner for Compassoft," said Compassoft CEO Paul Bach. "The life sciences industry requires the integrity of data and record-keeping through air tight auditing and documentation practices, which is what Compassoft delivers with its unique software solutions. Today over 60 major pharmaceutical and life science firms use Compassoft software to meet stringent regulatory requirements."

PSC will distribute, implement, validate and support the following Compassoft products:

* Compassoft Enterprise: A server-based application that automatically discovers EUC applications across distributed computers in the enterprise, maps dependencies to primary databases, compares iterations of data sources and reports on critical changes (whether intentional and valid or caused by error or fraud) that could lead to financial misstatements or non-compliance. Compassoft Enterprise includes server-based versions of DaCS and ExChecker capabilities.

* ExChecker: An auditing application designed to assist Excel users in the analysis, development and auditing of spreadsheet models. EXChecker's advanced filtering, grouping, and exporting procedures simplify auditing and can be used to dramatically reduce formula and calculation errors within spreadsheets.

* DaCS: The data compliance system that adds security, real-time cell-level audit trails, electronic signature control over changes, and electronic authorization and tamper detection to Excel spreadsheets. DaCS is the undisputed market leader for compliance with FDA 21 CFR Part 11 in the life science sector and is seeing high demand for Sarbanes-Oxley Section 404 internal control requirements based on its proven compliance track record.

Earlier this month, Compassoft announced that its compliance and auditing product line had successfully completed the SynTegra Software Supplier Process Audit as licensed by the Parenteral parenteral /pa·ren·ter·al/ (pah-ren´ter-al) not through the alimentary canal, but rather by injection through some other route, as subcutaneous, intramuscular, etc.

par·en·ter·al
adj.
1.
 Drug Association (PDA (Personal Digital Assistant) A handheld computer for managing contacts, appointments and tasks. It typically includes a name and address database, calendar, to-do list and note taker, which are the functions in a personal information manager (see PIM). ). The PDA audit requires that software suppliers to the pharmaceutical and life-sciences industry meet pre-defined standards that also comply with FDA regulations.

About Compassoft

Today, more than 150 major corporations worldwide -- across a broad range of vertical markets -- use Compassoft, Inc. for the discovery, validation and control of end-user applications. Compassoft, a venture backed software firm based in Scotts Valley CA, has won numerous awards for its technology and holds several US and international patents on its technology. Representative customers include ABN AMRO, Allergan, Allied Irish Bank, Alpharma, AstraZeneca, Bayer, CitiGroup, Echostar, Eli Lilly, Immunex, Pfizer Prudential and Schering-Plough. For more information, please visit www.compassoft.com.

About PSC

Pharmaceutical Services Corporation (PSC) is an international consulting organization for the life sciences industries with offices in North America and Asia. PSC specializes in compliance consulting relating to FDA and SOX, EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. , JP, KFDA KFDA Korea Food & Drug Administration
KFDA Kansas Funeral Directors and Embalmers Association
, SFDA SFDA State Food and Drug Administration (China)
SFDA Saudi Food & Drug Authority
 and other world regulatory bodies. PSC's core expertise is in the implementation and validation of enterprise IT solutions in regulated environments. For more information on Pharmaceutical Services Corporation, please see http://www.biotech.com.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Mar 19, 2007
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