Medical Device manufacturers are required by the Food and Drug Administration (FDA) to track certain types of devices from manufacture through the distribution chain to patients. The FDA released 21 CFR Part 821, which governs the requirements around the tracking process.
The Regulations…
This is an evolving space and we are writing a series of articles to you help you navigate through the regulation changes:
Rapidly Changing USA and Worldwide Regulatory Environment
Medical Device Tracking – The Next Generation
How Can We Help?
Portford Solutions provides software, services, consulting, and support to help make this process as painless as possible:
- 21 CFR Part 821 Compliant Workflow Solution
- Automated Correspondence Generation
- Automated E-mail/Faxing
- Web Based Portal for Clinics
- Document and Image Management
- 21 CFR Part 11 Electronic Signatures
- Patient Data Management (HIPAA/PIPEDA Compliant)
- Dashboard and Management Reporting
- Technology Transition
- Device Disposition Audits
- Managed Services
Compliant Workflow
DocuNECT provides a compliant and validated workflow that ensures all follow ups are completed. All DocuNECT activities are recorded in a 21 CFR Part 11 compliant, human readable audit trail.
Automated Correspondence
There are a variety of correspondence types that are generated in the follow up process. This can be very time consuming and DocuNECT will auto generate letters in an Adobe PDF format for your approval.
Automated E Mail/Faxing
Once you have approved the letter, it can automatically faxed or e mailed at the touch of a button.
Document and Image Management
All of these documents are kept in the central repository and are easily found with state of the art searching capabilities.
21 CFR Part 11 Electronic Signatures
Compliant, audited workflows, combined with built-in 21 CFR Part 11 electronic signature, provide a clear, accessible data set for regulatory needs.
Patient Data Management
Have the peace of mind that your patient data is secure, HIPAA/PIPEDA Compliant and that Patient Recall is easily processed.
Dashboard and Management Reporting
DocuNECT provides real time utilization reporting for Management and Operations.
Device Disposition Audits
We can create your existing audit procedures or use our standard ones to ensure that you achieve the highest level of compliance.
Technology Transition
If you have data and documents in an existing system and need help to migrate to DocuNECT, we are experts and provide full validation documentation.
Managed Services
Portford offers a complete managed service that combines the cloud model with our call-center of trained device tracking specialists that will manage the entire process for you.
