Quality management for life sciences

Open Text has announced a new offering designed to help pharmaceutical and medical device firms manage quality and quality-compliance issues in the development and manufacture of new products.

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).

Open Text's Quality Management System integrates the key processes required for life sciences organizations, including:

• support for the industry standard corrective action/preventive action (CAPA) process,
• comprehensive auditing,
• employee training management, and
• regulated document management.