6 Essential Capabilities of a Complete eDHR System

While many manufacturers in medical technology manufacturing think they have an electronic device history record (eDHR) system, often it is incomplete because it still relies at least in part on paper. Even when manufacturers have automated core parts of their manufacturing, critical production processes like the DHR are still paper based or disconnected

Examples of incomplete eDHR software systems include islands of automation or app-like manufacturing execution system (MES) tools, both of which require printing the digital portion from the systems and merging that paper with the paper-based records from the rest of the production process to create complete DHRs. A legacy MES can also be an incomplete eDHR system, because all production capacity that isn't automated using the MES often still has paper-based DHRs.

Whereas an incomplete eDHR system offers insufficient visibility, traceability, and data integrity, a complete eDHR solution enables smarter, faster manufacturing processes, so medtech manufacturers can make immediate performance gains at every step.

How to Tell If You Have a Complete eDHR System 

A modern MES solution is designed to provide a complete eDHR. For example, MasterControl's purpose-built electronic device history record software digitally connects every step of the manufacturing process rather than just a selection of steps. This allows manufacturers to easily create the entire, beginning-to-end eDHR in medical device manufacturing.

As I recently wrote for Medtech Innovation News, a complete eDHR system like MasterControl Manufacturing Excellence will digitize every step of production while also incorporating six elements critical to the manufacturing process.

1. Electronic documentation

A complete system provides a digital master template and a DHR, with system functionality that supports the need to review, approve, and execute a master template to create the eDHR templates and final documents.

2. Good documentation practice (GDP) process

A complete system serves as a GDP guidance system for better data integrity, with data-driven prompts to improve outcomes throughout production.

3. Quality review

An end-to-end system makes complete good manufacturing practice (GMP) document review by exception possible, with every step and human interaction digitized.

4. Product volume

A complete system not only automates a single DHR from beginning to end, but also allows medtech manufacturers to easily manage thousands of product variations.

5. Software validation

A complete system must be validated, and a modern MES solution simplifies software validation without compromising compliance.

6. Data visibility

A complete system digitizes, improves, puts into context, and maintains all production data in one place.

Conclusion

Relying on an incomplete eDHR system yields incomplete digitization, incomplete data, and incomplete visibility. With a complete, end-to-end eDHR system, manufacturers can capture and leverage all the data needed to optimize production while ensuring compliance with FDA 21 CFR Part 820 requirements.

For more info on this topic, see the Med-Tech Innovation News article "Why Having End-to-End DHR Is Crucial - and What It Looks Like."

References:

1. "Why Having End-to-End DHR Is Crucial - and What It Looks Like", Brian Curran, Med-Tech Innovation News, June 17, 2022.