Electronic Device History Records

Challenges of Medical Device Manufacturing

To succeed in a highly competitive global market, every manufacturing organization has to strive to simultaneously improve their product quality, reduce production costs and minimize lead times. Medical device manufacturers often face additional challenges on top of these related to the management of paper Device History Records (DHR), which are required by regulatory agencies to record production details for each product manufactured. Effort related to creating, maintaining, printing, tracking, reviewing and storing DHRs poses a significant cost and effort for most medical device manufacturers.

Electronic Device History Record (eDHR) Management

Electronic Device History Record (eDHR) systems are designed to streamline DHR operations and provide several additional benefits related to electronic management of manufacturing execution. This is achievable because eDHR is one critical subset of functionality provided by a broader solution called a Manufacturing Execution System (MES). An MES is a control system for managing and monitoring work-in-process (WIP) on a factory floor. An MES keeps track of all manufacturing information in real time, receiving up-to-the-minute data from robots, machine monitors and employees.

Functionalities of Electronic Device History Record (eDHR) Systems

When leveraged together, MES and eDHR systems can provide a wide array of benefits to regulated manufacturers including:

• Reduced data entry errors and associated NCRs/deviations via real-time electronic data validation
• Automatic equipment status checks and status logging
• Automatic alerts for exceptions
• Real-time material genealogy, tracking and visibility
• Increased transparency of manufacturing process via system dashboards and reports
• Enforcement of quality standards and electronic capture of inspection points/Laboratory Information Management Systems (LIMS) results
• Faster and improved equipment/tool calibration checks
• Automated operator training record checks and management in real time
• Full integration with supporting systems (e.g. ERP, Automation, LIMS, DMS, etc.)
• Reduced time and costs associated with quality reviews due to decreased errors and possibility to “review by exception” (i.e. only reviewing alerts raised by the system, since all eDHR inputs are automatically checked and controlled)

Engineering’s Expertise: MES and eDHR

The goal of a Manufacturing Execution System (MES) is to improve productivity and reduce cycle times while still enabling manufacturers to produce quality products. Medical device manufacturing customers who have partnered with Engineering for their MES and eDHR initiatives have seen the following benefits:

• Reduced scrap and waste
• Increased up-time
• Elimination of just-in-case inventory
• Reduced “fire drill costs”
• Faster reactions and flexibility to production issues and to changing market demands
• More informed, data-driven decisions about production
• Improved quality and more consistent quality compliance
• Improved throughput

Interested in speaking to one of our experts? Contact us at info@indx.com.