Quality Management Solution For Life Sciences Companies

Flexible Solution Manages Product Quality Issues and Compliance for Pharmaceutical, Medical Device Companies

Open Text™ Corporation (NASDAQ: OTEX, TSX: OTC), a global leader in enterprise content management (ECM), recently announced a new solution that helps pharmaceutical and medical device companies manage quality and quality compliance issues in the development and manufacture of new products. Open Text showcased the solution at the DIA Annual Meeting in Boston, June 22-26 at the Boston Convention and Exhibition Center.

In the life sciences industry, a quality management process is critical, for both regulatory compliance and continuous product improvement. However, quality management practices and support systems can quickly break down when the number of people and locations involved in the process is expanded beyond a single-site and a few dozen employees. Open Text's solution, called Livelink ECM – Quality Management System, gives pharmaceutical, medical device, biotechnology and diagnostic companies a flexible and expandable framework to manage quality issues and initiatives across a large, complex and distributed organization. The solution provides a single approach for managing all documentation and workflows, plus the ability to easily configure forms and information collection for new quality programs.

Livelink ECM – Quality Management System, which tightly integrates with an organization's controlled documents process, enterprise records, and document collaboration workspace, complies with the electronic records provisions of the U.S. Food and Drug Administration's (FDA) 21 CFR Part 11, while addressing the needs for Pharmaceutical Best Practice (21 CFR 210 and 211), Biological Best Practice (21 CFR 600-680) and Medical Device Best Practice (21 CFR 820).

"Product quality and safety are the top concerns for life sciences organizations," said Bill Forquer, EVP Marketing at Open Text. "Customers need to be able to adapt quickly to the ever-changing requirements associated with quality management, whether they are dealing with one or 10 locations. Livelink ECM – Quality Management System meets this critical need by giving customers a flexible, easily expandable solution that brings a consistent and compliant approach to quality management for the entire organization."

Livelink ECM – Quality Management System integrates the key processes required for life sciences organizations, including:

• Support for Corrective Action Preventive Action (CAPA) Process: CAPA is the industry's process standard for capturing, tracking and reporting quality issues, including observations, complaints, adverse events and audit findings. The Quality Management solution uses forms to capture and present data and information, while workflows are used to integrate the various phases of the CAPA process.
• Comprehensive Auditing: Auditing capabilities allow users to create audit templates that can then be used to prepare for specific audits, which flow through workflows for audit initiation, planning, scheduling, execution, reporting, and follow-ups.
• Employee Training Management: Training capabilities help to ensure that proper training is conducted by the appropriate staff and auditable training records are maintained. The solution manages training content and programs, stores employee training records and maintains detailed registration and licensing records for compliance management.
• Regulated Document Management: Provides lifecycle management of regulated documents. Documents that are needed for audits, CAPA requirements, training and or for other compliance issues can be created, reviewed, approved, edited and maintained within the Quality Management System repository in Livelink ECM. This functionality can be built into the workflows for both audits and CAPA.

Livelink ECM – Quality Management System is available now. For more information please visit: www.opentext.com/2/sol-products/sol-pro-compliance-governance/pro-quality-management-system.htm.

For more information on all of Open Text's Pharmaceutical and Life Sciences solutions, please visit: www.opentext.com/2/sol-industry/sol-ind-pharma.htm.

About Open Text
Open Text, an enterprise software company and leader in enterprise content management, helps organizations manage and gain the true value of their business content. Open Text brings two decades of expertise supporting 46,000 customers and millions of users in 114 countries. Working with our customers and partners, we bring together leading Content Experts™ to help organizations capture and preserve corporate memory, increase brand equity, automate processes, mitigate risk, manage compliance and improve competitiveness. For more information, visit http://www.opentext.com.