Compassoft and Pharmaceutical Services Team Up - Offer 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 between Pharmaceutical Services Corporation (PSC) and Compassoft, Inc. The partnership will help these companies manage operational risk and meet worldwide regulatory mandates from the Food and Drug Administration (FDA) 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 (EUC) 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™, EXChecker™ and DaCS™ 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, CEO 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 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 Part 11) and Section 404 of the US Security and Exchange Commission’s (SEC’s) Sarbanes-Oxley Act 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 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.
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