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Camstar Systems Inc.

FDA Compliance

Free Web Cast On Prevention and Early Detection of Product Quality

Live demonstration of Camstar’s MedicalDeviceSuite

Published: Monday, April 12, 2010 - 15:20

(Camstar: Charlotte, NC) -- Medical device companies are operating in a challenging environment of continuously innovating and launching new products while reducing product and process variability and risk and simultaneously complying with stringent Food and Drug Administration (FDA) regulations. Based on public data, there is a strong correlation that as a medical device manufacturer’s revenue increases through product and process innovation, their rate of adverse quality events such as product recalls, medical device reports (MDR), etc. also increases. Many companies have made heavy investments in a traditional quality system, and have seen little to no improvement in addressing these challenges.

But not all medical device companies are experiencing this, as some proactive companies have take action to balance these competing challenges and reverse this disturbing adverse quality event trend. How are they achieving this? Through electronic device history records (eDHR).

The key is prevention and early detection through an electronic device history record (eDHR/EBR) system. The eDHR is not just taking your paper device history records and converting them into an electronic format; it’s modeling your process in a structured way so that there are automated preventive controls which enforce proper procedure, so that you manufacture, test, and inspect your product right the first time, every time. And FDA compliance becomes a by-product of this approach.

In this web cast session, to be held on May 6,at 1 p.m. EDT, “Prevention and Early Detection: The Science of Advancing Product Quality through eDHR,” you will see a live demonstration of Camstar’s MedicalDeviceSuite, with a focus of eDHR/EBR. You will hear how proactive companies are using eDHR to reverse the negative adverse event trend. And you will learn how an eDHR system can enable you to:

• Prevent avoidable issues through automated enforcement of the 5 Ms (man, material, method, machine, measurement)

• Reduce adverse quality events: recalls, MDRs, corrective action/preventive action (CAPA), complaints, etc.

• Automatically collect quality and manufacturing data throughout the supply chain to enable:

  • Real-time detection of deviations, nonconformance, negative trends, etc.
  • Rapid intelligent root cause analysis
  • Rapid identification and traceability
  • Real time feedback for product/process risk through visibility to failure mode occurrence metrics

• Improve operational efficiencies, cycle times, and inventory by streamlining operations (by removing nonvalue-added inspections/verifications, etc.) and detailed visibility to work in process (WIP) status

• Reduce new product introduction timelines and risk by feeding existing product information into development to optimize design, process, and controls

• Reduce cost of compliance and cost of poor quality

• Capture entire as-built and as-maintained device history record including full product genealogy/traceability

• Maintain complete audit trails to meet FDA requirements

• Reduce internal/external audit risk


Who should attend

Manufacturing, quality, operations, engineering, and IT professionals involved in life sciences.

Register here.


About The Author

Camstar Systems Inc.’s picture

Camstar Systems Inc.

Camstar is a global provider in providing scalable, enterprise software solutions that help manufacturers deliver the highest quality products on time, the first time, every time. Camstar is a privately owned company experiencing continued growth in key markets worldwide. Founded in 1984, Camstar has been a leader in enterprise manufacturing software and quality solutions for 25 years. Camstar is headquartered in Charlotte, North Carolina, and maintains offices worldwide to serve its global customers.