A complete solution for life science organizations to ensure quality regulatory compliance in their products and services.
For any life sciences organization, a quality management process is critical, for both regulatory compliance and continuous improvement initiatives. However, quality management practices and support systems that prove adequate to a single-site organization with a few dozen employees quickly break down if they are not adjusted to meet the increased demands posed by expansion to additional locations and a large number of new users.
A Complete Quality Management Solution for Life Sciences
Open Text’s Livelink ECM – Quality Management System gives life science organizations, including pharmaceutical, medical device, biotechnology, and diagnostic companies, a flexible and expandable solution to manage quality issues and initiatives. Quality Management System provides a fully integrated solution that 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 Good Manufacturing Practice (21 CFR 210 and 211), Biological Good Manufacturing Practice (21 CFR 600-680) and Medical Device Quality System Regulations (21 CFR 820).
Quality Management System integrates the key processes required for life science organizations, including Corrective and Preventive Actions (CAPA), Audits, Training and Regulated Document Management into an enterprise-level solution.
Support for CAPA
Life science organizations are required to capture, track and report on event discrepancies of various types. CAPA allows the capturing, tracking and reporting of various quality issues, including observations, complaints, adverse events, deviations, non-conformances and audit findings. There are four main phases within CAPA: Incident Phase, Investigation Phase, Planning Phase and Execution Phase.
Configurable forms are used to capture and present data and information throughout the process, and configurable workflows are used to integrate the various CAPA phases, along with the other processes, such as Audit, Training, and Regulated Document Management. CAPA allows the unique identification of incoming sources of product and quality data. It facilitates investigation and analysis to allow comprehensive corrective and preventative action plans to be put in place and tracked to conclusion. Verification and validation of the specific actions or remedies are also specified and tracked in CAPA.
Comprehensive Auditing
Audits are a key tool used for life science organizations to assure that quality initiatives are in compliance with established quality requirements and to determine the effectiveness of the overall quality system. Audits can be applied to various entities, including external suppliers, vendors, internal departments, individual processes and systems.
The Quality Management System audit capability allows users to create audit templates that can then be used to prepare for specific audits. Audits flow through a typical workflow, including audit initiation, planning, scheduling, execution, reporting, and follow-ups. When an Auditor generates an Audit from an Audit Template, the Audit becomes available for execution. As the Audit is executed, the Auditor completes each section of the audit form until all areas are completed. Once the Audit is completed, it is closed, at which point the Audit becomes an Audit Record. Audit findings or observations can then be used to generate a CAPA. Follow-up activities are scheduled and tracked as needed.