CIMdata PLM Industry Summary Online Archive

11 October 2005

Product News

AssurX Announces Immediate Availability of CATSWeb Process for Document Control

AssurX, Inc., a supplier of Enterprise Quality and Compliance Systems, announced the immediate availability of CATSWeb Process for Document Control, allowing built-in, easy and effective management of the controlled content life cycle from change orders through release approval, dissemination and training. With recent high profile corporate compliance scandals being thrust into the spotlight, the ability to provide rapid access to current and accurate documents has become a critical issue with new and updated industry and government regulations at all levels. CATSWeb Process for Document Control allows firms to improve enterprise-wide visibility of process changes, reduce risk and labor costs associated with use of erroneous and outdated procedures, and demonstrate regulatory compliance.

CATSWeb Process for Document Control provides an intuitive workflow environment for managing the entire lifecycle of content (procedures, specifications, drawings, etc.) via integrated change orders, version control and training tasks.

"The training component of CATSWeb is especially valuable because federal inspectors often examine an organization's training programs, and evidence that the training actually occurred, to get a feel for the level of control and discipline," said Sal Lucido, VP of Enterprise Solutions. Just as a Corrective and Preventive Action (CAPA) program is often cited as a bellwether with FDA inspectors for other operations, a strong and well-documented training program is also an important early indicator for all inspectors. CATSWeb Process for Document Control makes it easy to quickly demonstrate that the training program is thorough and reliable.

Key benefits for all users include:

•  Managing and distributing content, including SOPs, procedures, drawings and datasheets.

•  Facilitating compliance with regulatory requirements and standards including cGMP, ISO 9000, 21 CFR Part 11, SOX, and HIPAA.

•  Making relevant content easy to locate, view, print, e-mail and download.

•  Providing full text search across the entire content repository.

•  Automatic notification regarding new, updated and recalled documents.

•  For supervisors to manage employees, assign new hire document training and training for new roles, and efficiently document monthly activity.

•  Content managers to define a document's affected areas, automatically set training tasks and access rights and also receive automatic notifications of document change request status.

Unveiled at the recent AssurX Summit User Conference, CATSWeb Process for Document Control was enthusiastically received. Users commented that CATSWeb Process for Document Control includes needed functionality that is missing in many competitive solutions, is much easier to configure and use, lends itself to rapid implementation, and delivers faster ROI.

Annette Schaps, Director of Quality and Regulatory Compliance at Thermage, Inc. states that, "After looking at various PLM systems, we found many of the solutions required major workflow changes, lacked flexibility and were high cost. CATSWeb Process for Document Control is currently being used for electronic routing and approval of Engineering Change Orders. In addition to being able to review the status or the changes and view the document itself, we really like the ability to have the training requests automatically launched after the document is released."

"An August 2005 FDA guidance document states that companies can significantly enhance their manufacturing decisions with effective, intelligent risk management policies," notes Tamar June, VP of Strategic Marketing. The International Conference on Harmonization (ICH) concurs.

Bottom-line: By leveraging sound policies and tools including CATSWeb Process for Document Control, companies have an unprecedented opportunity today to seize the compliance initiative, satisfy regulators, and significantly improve their operational efficiencies.

AssurX, Inc. provides companies with best-of-breed enterprise-wide global solutions for their quality and compliance system needs. CATSWeb is the proven leader as the industry's system of choice-used at FDA-regulated and ISO/QS 9000 certified companies around the world. CATSWeb is a zero client application that can be accessed from any computer, running any operating system, with any Web browser, anywhere and anytime that an Internet or intranet connection is available. AssurX is headquartered in Morgan Hill, CA with satellite offices throughout North America and Europe. More information about CATSWeb and AssurX can be found at http://www.assurx.com .

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