2019 - Effective Records Management and Document Control for Medical Devices

The document management system for medical device industry should help companies have control over critical activities such as:
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