In today’s fast-paced and ever-evolving life sciences industry, digitalisation has become an essential aspect of manufacturing operations. One of the key digital tools that can help life science manufacturers improve their operations is the electronic Device History Record or eDHR. 

In this blog post, we’ll explore the importance of eDHR and eDHR software for life science manufacturing and how it streamlines their day-to-day processes.

What is eDHR?

An eDHR (or alternatively Electronic Device Records, EDR) is a digital record that captures all the information and documentation related to the production of a medical device or biotech product. It replaces the traditional paper-based system with an electronic system. 

The eDHR contains information about the materials used, production processes, test results, and any other relevant information related to the device. This record provides a complete audit trail that is easy to access and review, which reduces the risk of compliance issues and improves overall data integrity.

Advantages of eDHR over Traditional Paper-Based Systems

eDHR systems offer several advantages over traditional paper-based systems. 

  • They reduce the need for manual data entry and paper-based documentation. This not only saves time but also reduces the risk of errors and inaccuracies.
  • They provide real-time access to production data, enabling manufacturers to monitor and analyse production processes as they happen. This allows manufacturers to quickly identify potential issues and take corrective actions before they become major problems.
  • They improve product traceability and quality control. By capturing all relevant production data and documentation in a single, electronic system, manufacturers can more easily trace the production history of a product and identify the source of any issues.

Compliance with Regulatory Requirements

One of the biggest advantages of eDHRs for life sciences manufacturing is their ability to ensure compliance with regulations. The EMA and other regulatory bodies require manufacturers to maintain complete and accurate records of their production processes. 

EDHR solution diagnostics manufacturers enable life science companies to digitise their documentation and data collection processes helping them become compliant with legal requirements.

In addition, eDHRs can provide real-time alerts and notifications of potential compliance issues. For example, if a production process deviates from established procedures, the eDHR system can alert the appropriate personnel and prompt them to take corrective action.

Improving Quality Control and Product Traceability

When it comes to maintaining quality, traceability can help you discover any problem areas within your production process. Traceability is necessary for manufacturing because it tracks or documents the movement of products and materials throughout the supply chain. If the company has no system in place to make this tracing easier, audits will become a nightmare.

Traditional paper-based systems can make it difficult to maintain and access these records, leading to potential compliance issues. eDHR or EDR manufacturing solutions solve this problem by providing a centralised database for all manufacturing information. This makes it easy for manufacturers to access historical data and documentation.

Enhancing Efficiency and Reducing Costs

Implementing an eDHR solution for medical devices can significantly enhance efficiency and reduce costs in several ways:

  • Improved Data Accuracy: Medical device manufacturing involves the production of large amounts of products and it’s easy to lose track of item turnout. An eDHR solution eliminates the need for manual data entry and human error, leading to improved data accuracy and reducing the likelihood of errors that could be costly if not addressed. 
  • Faster and More Efficient Processes: EDR manufacturing solutions streamline the production process, reducing cycle times and minimising the risk of bottlenecks. By automating data capture, product testing, and quality control processes, medical device manufacturers can significantly reduce the time and effort required to produce and put their products on the market.
  • Enhanced Regulatory Compliance: With an eDHR solution, medical device manufacturers can ensure that they are meeting all regulatory requirements related to device history records. An eDHR system provides a complete audit trail that is easy to access and review, which reduces the risk of compliance issues.
  • Reduced Costs: The elimination of paper-based records helps companies save on operating costs.

Best Practices for Implementing an eDHR System in Life Sciences Manufacturing

Implementing an eDHR system is a huge undertaking and it requires immense planning and execution. There are best practices that you can follow to make the implementation less cumbersome. Here are some:

1. Develop a comprehensive implementation plan that outlines each step involved in the process. 

2. Work with the right eDHR system and provider. A system that works for you helps you scale quickly. 

3. Clearly define the roles and responsibilities of all stakeholders in the business involved in this implementation. 

4. Ensure that all persons involved have the proper training in the use of the new system and are constantly updating their knowledge each time the system actualises. 

5. Test and validate if the eDHR system you use meets all regulatory requirements in your industry. This requires the assistance of your legal team and individuals involved in meeting regulatory requirements.

6. Utilise change management process as you adopt a new system for your business to make sure that everything is documented, evaluated and approved.

Interested in learning more about Seabrook’s GxP-Compliant eDHR solution? Contact us today to Schedule A Demo and see how our current solutions can help streamline your device manufacturing process.