Prevention and Early Detection: Error-proofing with eDHR

See How Proactive Companies use eDHR as a Strategic Solution

Dan Matlis, Axendia
Jeff Russell, Camstar Systems, Inc.
Greg Robino, Camstar Systems, Inc.

In Medical Device Manufacturing, electronic Device History Records (eDHR) are no longer an option, but an imperative for improving product and process quality, reducing risk, and driving profitability.Request access to this on-demand webcast to learn how you can create a self-auditing eDHR that creates significant business value for your operations.In this webcast, you will learn how a true eDHR system employs a structured process model that defines and automates preventive controls to collect data and eliminate avoidable issues. These automated controls enforce your Device Master Record to ensure product is manufactured, tested and inspected per defined requirements. By focusing on product quality with eDHR, compliance becomes a natural by-product. Register to see a demonstration of Camstar’s Medical Device Suite™, the world’s most intuitive, easiest to use eDHR. You will see how proactive companies use eDHR/EBR as a strategic solution to error proof manufacturing; lean operations and reduce operational costs; and mitigate regulatory and brand risk. You will see how an eDHR system can:

  • Eliminate manufacturing errors through automated enforcement of the 5 Ms (man, material, method, machine, measurement)
  • Immediately detect product and process issues, and rapidly diagnose root cause to reduce adverse quality events (recalls, MDRs, CAPAs, complaints, etc.
  • Improve operational and QA throughput, efficiencies and cycle times by streamlining operations, removing non value added QA verifications, and replacing costly paper
  • Use timely production and quality KPIs to make fast and effective decisions
  • Accelerate scope analysis by capturing entire ‘as-built’ and ‘as-maintained’ eDHRs, including full product genealogy and traceability
  • Reduce cost of compliance and cost of poor quality.