Portford Solutions Introduces DocuNECT for Device Tracking
Medical Device manufacturers are required by the FDA to track certain types of devices from manufacture through the distribution chain. The FDA released 21 CFR Part 821, which governs the requirements around the tracking process.
In response, Portford has developed DocuNECT, a web-based Device Tracking solution that is available in two ways:
- On-Site: Software implemented behind your firewall
- Hosted: A SaaS model where you can pay monthly
In addition, Portford also offers a complete managed service that combines the SaaS model with our call-center of trained device tracking specialists that will manage the entire process. Our services begin with fully documented policies and procedures that aid with FDA compliance.
Each client is allowed to customize the workflow to meet the profile of your device or specific needs. The operations team then follows these policies and procedures and conduct regular audits to verify compliance. We have a wide variety of reports and reporting methods which employ industry standards and tools.
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What Devices Need Tracking
The FDA mandates organizations to track the following medical devices:
- Glenoid Fossa Prosthesis
- Mandibular Condyle prosthesis
- Temporomandibular Joint (TMJ) Prosthesis
- Abdominal Aortic Aneurysm Stent Grafts
- Automatic Implantable Cardioverter / Defibrillator
- Cardiovascular Permanent Implantable Pacemaker Electrode
- Implantable Pacemaker Pulse Generator
- Replacement Heart Valve (Mechanical only)
- Implanted Cerebellar Stimulator
- Implanted Diaphragmatic / Phrenic Nerve Stimulator
- Implantable Infusion Pumps
- Silicone Gel-Filled Breast Implants
- Cultured Epidermal Autografts
The FDA released 21 CFR Part 821, which governs the requirements around the tracking process. The regulations were released in August, 1993 which has allowed a number of companies to become familiar with the regulation of data that needs to be collected and the follow-up processes that are required to insure reasonable attempts to obtain the data.
In practical terms managing Device Tracking comes with its own set of challenges. They include:
FDA Regulatory / Compliance
- Risk Due to Lost Data
- Inconsistent Follow Up
Multiple Systems and Technologies
- Located in Many Locations
- Incompatible Formats
- Lack of Technical Resources
No Consistent Protocols and Processes
- Lack of Information Control
- Privacy Concerns
- Require Heavy Customization
Lack of Reporting Tools
- No Strategic Dashboard
- Obsolete Reports
- Lack of Audit Trail
- Overly Manual Intervention Required
- Lack of Facility Space
- Lack of Audit Trail to Focus on Core Competency
How do you feel your organization measures up when it comes to efficiencies gained through outsourcing your Device Tracking? Contact Portford today to discuss best practices in your industry and identify how your business processes can be improved.
DocuNECT is a robust and versatile option for your Device Tracking needs. Our services begin with fully documented policies and procedures that aid with FDA compliance!
Each client is allowed to customize the workflow to meet the profile of your device or specific needs. The operations team then follows these policies and procedures and conduct regular audits to verify compliance.
Benefits of DocuNECT for Device Tracking include:
- Facilitates FDA Compliance
- Proven Validated System
One Centralized System
- One Hosted Location
- On-line Access 24/7/365
- Dedicated Technical Staff
Validated System Designed Specifically for Medical Device Tracking
- Automated Workflow Ensures Consistent Patient Data Follow-Up Process
- Compliant Solution 21 CFR Part 11 Electronic Signatures Enabled
- Patient Data Management According to HIPAA Guidelines
Managed Tools Include
- Management Dashboard
- Real Time Reporting
- Audit and Reconciliation
Managed Workflow Include
- Automated Faxing In / Out
- Predetermined Review and Escalation
- Dedicated Scanning and Indexing Center
Contact firstname.lastname@example.org learn more about DocuNECT for Device Tracking.