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Quality Management System

A Complete Quality Management Solution for Life Sciences

Life Sciences organizations use a variety of applications, databases and spreadsheets to record and track Corrective and Preventive Actions (CAPA) and complaints. These applications are often manual and do not provide tools for automating the required actions associated with CAPA and complaints management. Some examples include failure analysis, trend tracking or corrective action tracking.

Existing applications are often inadequate for maintaining the thorough and timely performance of quality objectives that require manual actions. Furthermore, U.S. Food and Drug Administration (FDA) and ISO requirements are continually changing and expanding, particularly in the areas of electronic signatures and electronic records.

Expanding Life Sciences companies face the challenge of adjusting to and managing periods of rapid growth. The need to adopt new business practices capable of meeting the demands of large organizations must be reconciled with regulatory requirements that mandate adherence to established procedures and the generation of documentation that proves this adherence.

For any Life Sciences organization, the quality management system is critical, both for regulatory compliance and for continuous improvement initiatives. However, quality practices and support systems that proved 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 users.

Open Text’s Livelink ECM – Quality Management System gives Life Sciences organizations, including pharmaceutical, medical device, biotechnology, and diagnostic companies, a flexible and expandable solution to manage quality issues and initiatives.

• Features

Click each of the following features to learn more about the key capabilities of Quality Management System:

• Comply with FDA regulations  
  Comply with the electronic records provisions of FDA 21 CFR Part 11, while addressing the needs for Pharmaceutical Best Practice (FDA 21 CFR 210 and 211), Biological Best Practice (FDA 21 CFR 600-680) and Medical Device Best Practice (FDA 21 CFR 820).
• Integrate CAPA processes  
  Use Quality Management System’s forms to capture, track and report on various quality issues (observations, complaints, adverse events, deviations, non-conformances and audit findings) under CAPA’s four main phases: Incident, Investigation, Planning and Execution. Quality Management System’s workflows integrate the phases, along with the other processes like Audit, Training and Regulated Document Management.  
• Provide comprehensive auditing  
  Quality Management System provides the ability to define custom audit templates and an audit workflow that includes steps such as audit initiation, planning, scheduling, execution, reporting, and follow-ups. Audits are initiated from Audit Templates and after all sections of the audit form are complete, it is closed and becomes an Audit Record, which can then be used to generate a CAPA.
• Manage regulated documents  
  Quality Management System is designed to work with Open Text's Livelink ECM - Regulated Documents. Regulated Documents is needed to provide the ability to comply with FDA 21 CFR Part 11's requirements for electronic signatures and the management of electronic records, such as policies, standard operating procedures, clinical trial data and documents, manufacturing records and specifications, validation reports, bills of materials, drug data sheets and regulatory submissions.
• Manage employee training  
  Quality Management System manages training content and programs and maintains auditable records of employee registration, licensing and training.

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