Medical device manufacturing is a modern marvel essential to delivering numerous health care services. However, FDA regulations and classifications can keep manufacturers on their toes. Having the proper documentation and visibility into production is vital to get your product from the shop floor to sales. Enter the electronic device history record (eDHR).

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Paper-based and hybrid systems are on the out, with eDHRs gaining popularity in the last few years. In this article, we’ll spell out precisely what an eDHR is, how it can help your business and why it’s an essential part of an MES solution.

Table of Contents

• What Is a DHR?
• What Is an eDHR?
• Key Benefits
• Importance of EDHR in MES
• eDHR Requirements

What Is a DHR?

A device history record is a tool used to maintain and establish procedures to verify whether manufactured products follow the device master record. It contains the part requirements and the how, what and when of manufacturing medical devices.

Think of a device history record as the journal of an explorer. You can find the map and the directions to get to new locations, but you’ll also discover exactly how the explorer travailed through various paths and terrains. The FDA has specific details about what a device history record should contain:

• Date or dates of manufacture
• Manufacturing quantity
• Quantity of products distributed
• Acceptance records
• Primary identification label and labeling used for each product unit
• Unique device identifier (UDI) or universal product code (UPC)

What Is an eDHR?

An electronic device history record (eDHR) is a digital management tool that stores the information needed in a device history record. It provides the blueprint for ingredients and processes and the details of what happened during each manufacturing step.

Like the similarities of the Targaryens in House of the Dragon and Game of Thrones, eDHRs may resemble device history records. Still, their medium of use offers up additional capabilities. For example, traceability is quicker and more reliable, and the ability to integrate with other digital systems like MES or ERP software.

What Information Does an eDHR Contain?

Manufacturers often follow a unique set of processes. Due to that, each eDHR doesn’t contain the same information. It can vary based on device, factory size and production methods. In addition to mandated information a device history record must have, an eDHR needs:

• Workforce tracking
• Document revisions
• Electronic signatures
• Order information
• Device master record compliance records

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Primary Benefits

Implementing eDHR into your manufacturing processes can be daunting. Turning paper into digital is time-consuming, but no pain, no gain. Let’s look at some of the improvements you’ll make with eDHR.

Added Compliance

Compliance is king in a world of FDA rules, quality service regulations and medical device reporting. Scrambling for paper copies, rummaging through batch reports and looking through spreadsheets isn’t a recipe for success, especially during an FDA inspection.

Besides making it easier to extract data, digital entries and prompts neutralize human errors like illegible handwriting, blank sections and double entry.

Better Visibility

Getting from A to B isn’t enough for medical device manufacturing. You’ve also got to see exactly how you got there. The ability to track each part of the production process in real time allows you to access data and information that can help streamline operations.

Fewer Errors

To err is human, but standardization and real-time tracking can minimize exceptions. Easy access to historical data and logs help pinpoint where mistakes occur, allowing you to prevent issues in the future.

Containment Management

Despite work instructions, stringent checks and quality control, sometimes a product that’s not up to the mark is distributed. In these situations, time is of the essence. eDHRs allow you to track down and recall products that have been affected.

Optimized Production

An end-to-end eDHR system allows you to collect and collate data during each manufacturing process step. Having this information handy in a digital format will enable you to analyze and optimize cycle times, yields and capacity.

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eDHR and MES

In Industry 4.0, the popularity of MES solutions has risen. An MES solution with eDHR capabilities is no doubt attractive.

However, it’s crucial to understand that MES doesn’t automatically translate to a complete eDHR solution. A legacy MES system or specific apps may provide consolidated data, but you’ll have an incomplete eDHR. You may need to convert device history records into digital form by scanning paper copies or resorting to manual data entry.

Key Requirements

An incomplete eDHR system is akin to buying an iPhone with none of the accessories. Does it do the job? Yes. But will you still need to upload data or compile reports manually? Perhaps.

We’ve discussed the importance of having a complete eDHR system, but what does that entail? You need to meet five requirements to qualify.

1. Electronic Documentation

It’s in the name, so it stands to reason that electronic requirements are front and center of any eDHR. For starters, you’ll need a digital master template and device history record, allowing you to review, approve and complete a master template to create eDHR templates and documents.

Template requirements include:

• Approval routing
• Watermarks
• Signature manifest
• Version and revision control

2. Good Documentation Practice (GDP) Process

According to the FDA, GDPs are guidelines followed to record raw data entries in a legible, traceable and reproducible format. Update training, navigate corrections and ensure data integrity with a GDP system, complete with work instructions for operators.

3. Quality Review

An end-to-end eDHR system makes review-by-exception a reality. Instead of muddling through stacks of documents, you benefit from fully-digitized steps and human interactions to identify where things went wrong and flag abnormalities.

4. Product Volume

Variety is the spice of life. Product variations in the world of medical device manufacturing aren’t uncommon, and being able to automate and manage multiple records is fundamental.

5. Data Visibility

Seeing is believing — or in the case of manufacturing — validating. Centralized data gives you real-time visibility into production performance and traceability of each step of operations. You’ll be able to glean analysis on productivity and exceptions that can be avoided.

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Conclusion

Keeping track of manual systems can be equivalent to scaling Everest with one hand tied behind your back. eDHRs can help with compliance, visibility and quality management. All the while, it provides a centralized source of information for every step of the manufacturing process.

So how can you integrate an eDHR solution into your operations? Check out our free MES software requirements template to find the best fit for your company.

Do you have any questions about eDHRs we may have missed? Let us know in the comments below.