Outsourced Device Tracking – 21 CFR Part 821

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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.

Click here to save the January 27, 2011 WebEx meeting in your Outlook Calendar or contact: info@portfordsolutions.com for more information about new product features or join us for a WebEx demonstration on January 27, 2011 at 10:15 am PST.

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

Customer Challenges
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

Labor Intensive

  • 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 Features
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 info@portfordsolutions.comto learn more about DocuNECT for Device Tracking.

Panasonic’s KVS5055C Scanner Delivers Superior Value

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Customers have made Panasonic’s KVS5055C hands down the best selling scanner since it was released this past summer. Whether you are looking to replace older scanner hardware or adding document scanning capacity boost your business efficiency with an A3-size, High Speed document scanner. The fast 90 ppm* scan speed and 200-page Automatic Document Feeder of the KV-S5055C make it ideal for both large-volume and distributed scanning environments. Panasonic’s unique paper feed mechanism also minimizes the possibility of damaging important documents and ensures precise feeding to make your office work even more efficient.

  • Stapled Document Detection: Multiple sensors are used to detect various types of stapled documents, and to immediately stop the scanner when a stapled document is detected. This minimizes damage to both the document and the optical glass
  • Ultrasonic Double Feed Detection: The KV-S5055C is equipped with an ultrasonic double feed detection sensor, which accurately detects double feeding even when scanning documents of various thicknesses
  • Ionizer: The ion-filled breeze created by the ionizer neutralizes the electrical charge on the documents to be scanned, and reduces the amount of paper dust that clings to their surface. This ion-filled breeze also flows through the paper path and removes paper dust from the scanning glass to reduce the need for the user to clean the glass
  • Scanning Glass Cleaning Brush: This brush directly cleans the scan glass to help reduce the amount of paper dust accumulation. This process, along with the Ionizer, helps to reduce the amount of maintenance necessary

Contact info@portfordsolutions.com or visit Panasonic’s web site at www.panasonic.com.

Creating the Ultimate Web Experience

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Customers have high expectations of websites: interactivity, personalization, relevant content, and more. Join us Tuesday November 16th 8am PST as EMC presents a Live Webcast on the best practices for creating, managing, and delivering dynamic web experiences.

With a solution from EMC and Portford, you can meet these demands and improve the entire web publishing process—delivering the most compelling experience to your customers

Attend this event to:

  • Learn about the best practices to use the Web to its fullest potential as a tool for marketing, branding, and business growth
  • Gain a comprehensive understanding of the powerful technologies EMC has to offer to optimize your web publishing process-from content creation to multi-channel web delivery to web analytics.
  • See how organizations have successfully built persuasive online experiences that leverage social media, personalization, realtime tracking, optimization, and rich media

Click here to register for this free EMC Live Event. Click here to see all upcoming EMC Live events.

Contact info@portfordsolutions.comto learn more about best practices for creating, managing, and delivering dynamic web experiences for your customers.