Compassoft First to Complete PDA Software Audit for Microsoft Excel Spreadsheets, Databases and Reporting Applications

Business Wire, March 12, 2007

Audit Certification Will Help Pharmaceutical and Life-Sciences Companies Meet FDA Regulations by Giving Them Access to Automated Spreadsheet Controls

SCOTTS VALLEY, Calif. -- To help pharmaceutical and life-sciences companies ensure their spreadsheets and databases meet the Food and Drug Administration's (FDA's) stringent compliance regulations, Compassoft Inc, a software leader in the discovery, validation and control of End User Computing (EUC) applications such as spreadsheets, databases and reports, today announced that its entire compliance and auditing product line has successfully completed the SynTegra Software Supplier Process Audit as licensed by the Parenteral Drug Association (PDA). The PDA audit requires that software suppliers to the pharmaceutical and life-sciences industry meet pre-defined standards that also comply with FDA regulations.

The audit was initiated at the request of a major international pharmaceutical company, one of the more than 60 pharmaceutical and clinical research companies that rely on Compassoft to inventory their research data, provide security, real-time logging and audit trails for the thousands of Microsoft Excel spreadsheets and databases containing lab statistics and other research and findings that are stored on desktops and laptops companywide.

"When I first saw Compassoft locate different versions of the same spreadsheets in email and desktop files, identify inconsistencies, show hidden pages and 'a second set of books,' I was impressed," said Microsoft General Manager, Emerging Business Team Cliff Reeves. "Compassoft can analyze data from Excel spreadsheets, Access databases, and relational databases to map dependencies and identify an audit trail. I believe it has an important role to play in any spreadsheet compliance strategy."

Rigorous SynTegra/PDA audits meet requirements for all computer product and service providers within the highly regulated pharmaceutical market Compassoft participates in with its industry-leading Data Compliance System (DaCS[TM]) technology that ensures compliance with Compassoft Completes PDA Software Audit - computerized reporting requirements such as the US Food and Drug Administration's Electronic Records and Electronic Signatures Rule (21 CFR Part 11) and other government regulations. DaCS is now offered as part of Compassoft Enterprise Edition, a computing platform for managing business critical data stored in spreadsheets, databases and reports on servers, desktops and laptops.

With this audit, Compassoft Enterprise has streamlined the process for adoption by all pharmaceutical companies, clinical research and medical device organizations. Today, over 150 public corporations use Compassoft technology for General Auditing, Risk Control, Sarbanes-Oxley or US Electronic Document Regulation 21 CFR Part 11 compliance.

"Pharmaceutical and life-science companies can now use Compassoft's compliance and auditing software to easily discover, validate and control the hundreds -- often thousands -- of spreadsheets containing critical research scattered throughout their distributed computing systems," said Paul Bach, president and CEO of Compassoft. "Spreadsheets have been the Achilles heel of data management because they are not always well documented or tested. Compassoft applies the security, control and logging sophistication used in production databases to the management of spreadsheets."

Reducing Risk Exposure in the Pharmaceutical Industry

The audit was conducted by SynTegra's PDA certified auditor who examined documented evidence of Compassoft's internal processes and procedures for its governance and control software to assure that it is in compliance with the PDA's established Supplier Audit Process Model (TR-32). The audit focused on 10 key areas: Quality System, Project Management, Software Methodology, Testing, Configuration Management, Manufacturing, Documentation & Records Management, Security, Training & Education and Maintenance.

Information on obtaining the complete audit report will be available on SynTegra's Audit Resource Center (ARC) Web site. SynTegra, LLC is a pharmaceutical supply chain and patient safety solutions provider, located at www.syntegrallc.com. In 2005, the PDA selected SynTegra to conduct audits and manage the audit library as a PDA licensee. The ARC library is maintained for pharmaceutical company subscribers who may "check out" audits under circumstances that maintain all appropriate confidentiality.

"The audit will be readily available to ARC subscribers from SynTegra so our customers won't need to conduct costly and time-consuming audits of their own," said Libby Koehn, founder and executive vice president of customer services. "Pharmaceutical and life-sciences companies recognize the importance of audits for both interpreting and meeting FDA guidelines, and we are pleased to offer a product that provides detailed change history while discovering and eliminating errors and other irregularities in Microsoft Excel spreadsheets."