Many organizations still operate paper based Quality Management Systems. While this may have been sustainable when the organization was in its infancy, the modern Life Sciences ecosystem requires interaction with many external partners CxO’s leading to a greater number of CAPA’s , Audits and Change Controls on an annual basis. As the scale of instances increase, the burden of a paper based system becomes unmanageable. A complete QMS contains capabilities ranging from Document control through Quality processes and Learning Management, in one centralised interface.
Listen to this webinar to see how an electronic QMS can assist your organization in:
- Establishing best practice SOP, Deviation, CAPA, Change Controls, Complaint and Audit processes
- Conducting Risk Assessment, Root Cause Analysis and Impact Assessment where appropriate.
- Creating Action Plans, and verifying their effectiveness.
- Improving efficiencies over the QMS tasks
- Reducing the risks of manual error
- Ensuring compliance to 21 CFR Part 11 and immutable audit trail.
- Avoid observations, 483 letters and fines
- Taking the resource burden out of creating dashboards/ periodic reports
Cyril Walsh, BIOVIA Senior Solutions Consultant
Duration: 57 minutes