New Product Automates and Controls Compliance Processes Across All Industries
PLEASANTON, Calif. – March 8, 2004 – Documentum, the leading provider of enterprise content management (ECM), today announced the immediate availability of Documentum Compliance Manager, an easy-to-use, web-based application that enables companies to securely create, store, share, revise, approve and distribute information within an automated and audited environment. With Documentum Compliance Manager, organizations can also develop, maintain and monitor content-related processes, in accordance with regulatory requirements, industry standards and business best practices. The new product accelerates time-to-market and enables business users within organizations to easily create and distribute controlled, regulated content.
Until now, organizations seeking such a solution had to build proprietary applications or pull together products from multiple vendors, resulting in costly integrations, complex deployments, inconsistent support and inadequate functionality. Documentum Compliance Manager builds on the strengths of the Documentum DocControl Manager, which has been successfully used for more than 7 years by nearly 200 companies, across a wide range of industries and geographies for a variety of controlled content processes.
Leveraging the award-winning Documentum ECM platform, Compliance Manager helps global organizations address regulatory and business requirements, across the entire content lifecycle, from creation to archival and disposition. Documentum Compliance Manager delivers capabilities that satisfy a broad spectrum of common compliance requirements, such as access control, authentication, data archival and retrieval, audit trails, electronic signatures and encryption. The new product also supports compliance with existing and evolving regulations and standards, including the Food and Drug Administration’s prescribed regulatory requirements for electronic records and signatures (FDA 21 CFR Part 11), International Organization for Standardization (ISO) 9000 quality guidelines, Security and Exchange Commission (SEC) and Environmental Protection Agency (EPA) regulations.
Controlled content, such as standard operating procedures (SOPs), materials safety data sheets, product and packaging specifications and plant engineering drawings, define an organization’s business rules and procedures. Too often, organizations take a risk by manually managing controlled content, and the consequences can be severe, including poor operational performance, prolonged production cycle times, citations for non-compliance or even shutdown of operations. Documentum Compliance Manager automates content control by creating a Web-driven knowledge chain that links disconnected, manual processes for collecting, sharing and applying controlled content to meet stringent quality goals and compliance requirements.
“The pharmaceutical industry faces the challenge of complying with a number of complex external regulations and internal policies associated with the research, development and manufacturing of new products,” said Jeff Kouba, director of R&D; Scientific Information Services at Allergan, a technology-driven, global health care company that develops and commercializes specialty pharmaceutical products for the eye care, neuromodulator and skin care markets. “As a long-time customer of Documentum, we have benefited greatly by using the Documentum ECM platform and Documentum Compliance Manager to help provide better visibility into and control over our operational and compliance processes, while continuing to maintain high product and service quality standards.”
Additional features of Documentum Compliance Manager include:
• Highly configurable lifecycle model – Complex processes controlling critical policies and content approval and release, such as engineering change notices, SOPs, electronic signatures and verifiable audits, can be easily defined and modeled, implemented globally, applied to business applications and adapted to virtually any industry.
• Advanced security and access control – Policies and procedures for preparing, identifying and protecting business-critical documents and other content can be easily established, implemented and enforced, ensuring that only authorized individuals can view, use, change or manipulate content and that these actions are correct, accurate, properly controlled and audited, to meet regulatory and business requirements.
• Management of all types of controlled content – including product and packaging specifications, material safety data sheets, work instructions, engineering drawings, SOPs and test protocols.
“Documentum Compliance Manager provides the visibility and control that allows companies in a wide range of industries to more effectively manage content through controlled repositories, process automation, collaboration, communications, archival and business integration capabilities,” said Dave DeWalt, president of the Documentum software division of EMC. “Enterprises can now take a holistic approach to compliance, assessing and immediately implementing proven products.”
Documentum, a division of EMC Corporation (EMC) (NYSE: EMC), provides enterprise content management (ECM) solutions that enable organizations to unite teams, content and associated business processes. With a single platform, Documentum enables people to collaboratively create, manage, deliver and archive the content that drives business operations, from documents and discussions to email, Web pages, records and rich media. For more information, visit Documentum on the Web at www.documentum.com.
This release contains "forward-looking statements" as defined under the Federal Securities Laws. Actual results could differ materially from those projected in the forward-looking statements as a result of certain risk factors, including but not limited to: (i) adverse changes in general economic or market conditions; (ii) delays or reductions in information technology spending; (iii) the dependence on one or a few products, the transition to new products, the uncertainty of customer acceptance of new product offerings, and rapid technological and market change; (iv) competitive factors, including but not limited to pricing pressures; (v) the volume and mixture of product and services revenues and the use of indirect sales channels; (vi) war or acts of terrorism; (vii) the ability to attract and retain highly qualified employees; (viii) fluctuating currency exchange rates; (ix) risks associated with strategic investments and acquisitions; and (x) other one-time events and other important factors disclosed previously and from time to time in EMC`s filings with the U.S. Securities and Exchange Commission. EMC and Documentum disclaim any obligation to update any such forward-looking statements after the date of this release.