- Solution
Overview - IEC 62304
Compliance - FDA 21 CFR Part 820
Compliance - FDA 21 CFR Part 11
Compliance
FDA 21 CFR Part 11 Compliance
Electronic records and signatures – Trustworthy, reliable
and equivalent to paper records
- Need to meet FDA´s regulations for electronic records and electronic signatures
- Must achieve FDA 21 CFR Part 11 compliance quicker
- Workflow is not standardized, difficult to configure and doesn´t provide
the security level needed - Cycle time of tasks and artifacts in the workflow is too long
- No complete management oversight as reports take too long
and take too many resources
Substituting paper records and handwritten signatures by electronic records and electronic signatures for manufacturers of pharmaceuticals or medical devices means compliance to FDA 21 CFR Part 11 is a must. With Polarion ALM you not only achieve but exceed all requirements of this rule set - out-of-the-box.
A secure audit-trail and accurate traceability for all artifacts throughout the lifecycle are guaranteed. Industry-proven processes out-of-the-box including automated routing, approval and incorporated escalation for overdue tasks reducing cycle times of your tasks come as a bonus.
Key Benefits
- Achieve FDA 21 CFR Part 11 compliance quicker
- Accurate traceability for all artifacts throughout the entire lifecycle – including all electronic signatures for changes and approvals
- Provides industry-proven automated processes delivered out-of-the-box for reuse or customization
- Reduces cycle time of tasks with automated routing, approval and incorporated escalation for overdue tasks
- Secure, time-stamped audit trail for exceeding all requirements for FDA 21 CFR Part 11 compliance
- Increases Management Oversight through advanced analytics and reports
Download FREE Documents
Polarion FDA 21 CFR Part 820
Full Compliance
Polarion FDA 21 CFR Part 11
Full Compliance
Polarion Medical Device
Solution White Papers pack
"Polarion provides the complete Infrastructure. All important components like Configuration Management, Traceability, Process support, Documentation and Checklists are not only available they are all pre-configured and integrated.
Our Customers
Here are a few examples of our customers in the Medical Devices, Biotechnology and Pharmaceuticals sectors:
