Smart Manufacturing 08/26/2022

Three benefits of eDHR for Medical Device Manufacturers

Three benefits of eDHR

According to a widely held view among medical device manufacturers, eDHRs are just an electronic form of what used to be "device history records," paper records of the products produced. But eDHRs in manufacturing execution systems also offer three key benefits.

When manufacturing medical devices and diagnostics, manufacturers must keep records of the products produced. These 'Device History Records' or DHR include production receipts and other records that are documented with a final inventory. Collection and documentation through electronic DHR (eDHR) in MES systems like Opcenter Execution eliminates the inefficiencies, errors and compliance issues associated with paper records. But the key benefits go far beyond that:

1. eDHR prevent errors before they occure

Through an eDHR implementation as part of a modern MES for medical device manufacturing, users are guided through their daily activities. This ensures that plant guidance is provided with up-to-date work instructions, qualified equipment and required certifications for employees, as well as the correct materials and recipes, and that all data is captured and signatures are recorded. Data collection at each point in the manufacturing process - from test values or results as well as barcode scans of actual components used - can be used to issue alerts and stop processes before human or machine error causes damage.

2. eDHR assist in damage limitation

If quality events nevertheless occur, eDHR immediately leads to the identification of the affected batches and products. This means that risk products affected in production can be immediately moved to the restricted warehouse and field recalls can be limited to products that are actually affected.
The electronic information about each step of the manufacturing process makes quality trends visible in production and quality dashboards and contributes significantly to improving KPIs.

3. eDHR increase process reliability

Prior to each step in the manufacturing process, the MES uses an eDHR functionality to check whether all data is complete and complies with the specifications. This "self-checking" feature of paperless compliant production also forms the basis for automated eDHR and higher process reliability. Streamlined, error-free manufacturing and inspection processes and shorter cycle times lead to higher production output. This helps bringing products faster to the customer and increases production figures, sales growth and profitability.