What you need to know about eDHR

Although it is one of the final steps, a device history record (DHR) is still very important. The DHR becomes a part of the manufacturer's quality system and ensures that the products manufactured meet all specifications as well as being able to identify each batch, lot or unit.

Device history records were, at one point in time, largely compiled by hand using paper-based systems. However, these antiquated systems are quickly becoming a thing of the past. They’re being replaced by electronic device history records (eDHRs).

Let's dive into the details on why electronic device history records (eDHRs) are taking the place of paper-based device histories. Furthermore, let's look at the key differences between eDHRs and their traditional counterpart.

1. What is an eDHR?
2. Why are eDHRs Important?
3. What information should be included in eDHR?
4. Why use an eDHR instead of paper?
5. Benefits
6. Regulatory Compliance

What is an eDHR?

It's crucial to understand what a traditional DHR is before learning about electronic device history records. Typically, Quality Management Systems house the DHR, and its purpose is to confirm that every manufactured batch adheres to the specifications in a Device Master Record. This way, manufacturers can be certain that each product meets safety requirements.

While the term "eDHR" may give off the impression that it is simply a digital version of a standard DHR, that isn't always accurate. Many organizations use electronic tools, such as Excel, to manage their device history records but still need to print them as part of their paper-based quality management system.

An eDHR is a paperless, electronic system that captures all information associated with the production of equipment and facilitates productive processes. And furthermore, it often lives within a larger system—like an eQMS—that guarantees its connection to other quality processes; therefore data cannot be siloed.

Additionally, the eDHR records any modifications made to the device, including firmware and software updates, as well as data collected during the operation of the device. This data can be used to track the performance of a device over its life cycle, and provide insights into how it is being used.

The eDHR also provides a secure audit trail for regulatory compliance purposes. By creating an electronic device history record, organizations can ensure that their devices are safe, secure and up to date. This in turn helps to protect the organization from any potential liability from faulty equipment or data loss due to outdated software. With an eDHR in place, organizations can rest assured that their devices are running safely and securely.

Why are eDHRs Important?

eDHRs offer a number of benefits over traditional paper-based DHRs. For one, they improve accuracy and completeness by reducing errors and omissions that can occur during the manual documentation process.

eDHRs also offer increased efficiency by enabling real-time tracking and updates, making it easier to identify issues and resolve them quickly. In addition, eDHRs reduce costs by eliminating the need for paper-based records and the associated costs of storage, maintenance, and retrieval.

Finally, eDHRs provide an increased level of security and data protection by ensuring that all records are stored in a secure electronic system. This eliminates the risk of data loss or theft due to paper record mismanagement or lack of access control.

What information should be included in eDHR?

The type and amount of information included in an eDHR is dependent upon the product, but some standard pieces of data that should always be included are:

• Bill of Materials (BOM)
• Device Master Record Reference
• Serialization and Lot Traceability Metadata
• Process Parameters Settings
• Calibration/Verification/Validation Documents
• Testing Results
• Nonconformance Records
• Quality System Documentation (e.g., procedures, training records, etc.)
• Maintenance Records
• Rework/Repair Records
• Audit Trail Metadata

An eDHR should also have the capability to collect additional information. This can include customer complaints and surveys, warranty return analysis, and defect trend data. The main purpose is to ensure that all relevant product data is documented in an organized manner, making it easy to access when needed.

Why use an eDHR instead of paper?

While an eDHR's ability to be displayed on a laptop instead of in a binder is certainly convenient, its true value lies in its connection to the rest of a QMS. This provides numerous benefits that cannot be replicated with a paper DHR, such as:

Everything in one place.

DHRs that are paper-based tend to be disconnected from other systems, and data can be difficult to locate. This also makes it complicated to determine how different types of data—such as complaints, nonconformities, and production information—relate to each other. When DHRs are electronic, they are integrated with the QMS which allows for sharing of crucial data and provides a more comprehensive view of what goes into a DHR.

Streamlined processes.

If you have used a paper DHR in the past, then you know that the process of compiling all of the necessary information can be slow and often results in errors. However, an eDHR can streamline processes by automating tasks like data collection and review. Additionally, it offers increased visibility into an entire DHR process so that manufacturers can identify any potential bottlenecks and address them accordingly.

Fewer quality and compliance risks.

The harsh truth is that paper DHRs leave you less prepared for quality inspections. The last thing manufacturers want during one of these already high-stress events is to be frantically looking through a list of PDFs, spreadsheets, or even filing cabinets to find the records needed. An eDHR ensures that not only can manufacturers easily find the documents they need, but also know they'll always be the most up-to-date version available - giving peace of mind.

Benefits

An Electronic Device History Record (eDHR) is a great tool for organizations to track the life cycle of their devices and maintain compliance with applicable regulations. The eDHR can provide valuable insights into how a device is performing over its lifetime, as well as help organizations identify potential risks or liabilities related to their equipment. By keeping an accurate record of an electronic device’s history, organizations can minimize any chances of problems down the road.

Benefits of eDHR include:

• Improved accountability and traceability of electronic devices
• Increased safety
• Better compliance with industry regulations
• Reduced risk of data loss or theft
• Improved service delivery

In addition, the eDHR canbe used to improve customer service by providing greater visibility into the performance and use of electronic devices.

Regulatory Compliance

In the medical device manufacturing industry, regulatory compliance is of utmost importance to maintain patient safety and quality control. The use of Electronic Device History Records (eDHRs) is becoming increasingly popular as a way to improve accuracy, efficiency, and traceability of the production process while ensuring regulatory compliance. This article will discuss the significance of regulatory compliance with eDHRs, FDA guidance, requirements, and benefits.

The FDA has issued guidance on the use of eDHRs in medical device manufacturing, outlining the requirements for electronic records to be considered equivalent to paper records. According to the FDA, eDHRs must be secure, traceable, and capable of being audited to meet the same regulatory standards as paper-based DHRs. The FDA has also emphasized the importance of proper documentation practices and record-keeping to ensure regulatory compliance and patient safety.

By implementing eDHRs, organizations can ensure that their records are compliant with the latest regulatory guidelines, reduce the risk of compliance issues, and improve patient safety and quality control.

Organizations are now integrating eDHRs with other systems to improve operational efficiency.  For example: The integration of eDHRs with LIMS. Integrating eDHR with LIMS allows laboratory personnel to access electronic device history records directly from the LIMS system. This provides a more comprehensive view of the manufacturing process, allowing laboratory personnel to quickly identify any issues that arise. It also reduces the need for manual data entry, improving accuracy and reducing errors.

Guidance for Better Manufacturing Operations

Direct connectivity to machines using a single solution to handle different data formats, protocols, and structures is the key to unlocking the power of Industry 4.0 and IoT for your business. Machine integration is the first step toward taking full advantage of these technologies.

Intraratio can help you discover the power of MES and yield management systems for your manufacturing process. Arrange now to speak with an MES expert who can guide you through the ins and outs of the right advanced solution for your manufacturing operation.

References:

1. FDA Guidance on Electronic Records; https://www.fda.gov/media/76449/download
2. Benefits of Implementing eDHRs in Medical Device Manufacturing; https://www.medgadget.com/2019/02/benefits-of-implementing-edhr-in-medical-device-manufacturing.html
3. eDHRs: A Practical Guide for Medical Device Manufacturers; https://www.mddionline.com/regulatory-quality/edhrs-practical-guide-medical-device-manufacturers

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