Electronic Device History Record (eDHR)

What is an eDHR?

An electronic device history record (eDHR) is a digital version of the traditional paper-based record used to document the production history of medical devices. It includes detailed information about the manufacturing process, quality control, and compliance with regulatory standards. eDHR systems streamline data collection, storage, and retrieval, ensuring that all relevant information is accurately recorded and easily accessible for audits and inspections.

Why is an eDHR software important?

eDHRs are crucial for maintaining compliance with regulatory requirements, reducing the risk of errors, and improving traceability for medical device manufacturers. They provide a comprehensive and accurate record of each device’s production history, which is essential for quality assurance and regulatory audits. By digitizing these records, companies can enhance data integrity, reduce paperwork, and ensure faster access to critical information.

Business challenges of paper-based DHRs

Today, most regulated device manufacturers still rely on paper-driven processes to compile their DHRs. Compiling a DHR using paper-based processes presents significant challenges in the MedTech industry. Manual documentation is prone to human error, leading to inaccuracies that can compromise product quality and regulatory compliance. Paper records are difficult to track and retrieve, resulting in inefficiencies and delays during audits or inspections. Additionally, the physical storage of paper documents requires substantial space and resources, increasing operational costs.

Compliance Costs

The need for rigorous recordkeeping and compliance can lead to increased operational costs.

Time to Market

Challenges in managing DHRs can lead to delays in product development and market launch.

Loss of Business Opportunities

Inefficient management of DHRs can hinder the ability to respond to market changes quickly.

Penalties and Reputation

Noncompliance can result in penalties, and errors in DHRs can lead to product recalls, safety issues, and plant shutdowns.

What role do eDHRs play in the MedTech industry?

In the MedTech industry, eDHRs play a vital role in ensuring the safety and efficacy of medical devices. They help manufacturers comply with stringent regulatory standards, such as FDA, GMP, and ISO requirements, by providing a transparent and traceable record of the entire production process. This transparency is essential for addressing any issues that arise and for continuous improvement in manufacturing practices.

Benefits of an eDHR software

An eDHR enhances compliance by ensuring accurate, real-time documentation of the production process. It improves traceability and data integrity, reducing errors and facilitating quicker audits. By automating data collection, eDHRs increase efficiency and reduce manual paperwork. They also enable faster issue resolution and continuous improvement, ultimately leading to higher product quality and reduced costs.

<span style="background-color: #f3f3f3; color: #323b42;">An eDHR enhances compliance by ensuring accurate, real-time documentation of the production process. It improves traceability and data integrity, reducing errors and facilitating quicker audits. By automating data collection, eDHRs increase efficiency and reduce manual paperwork. They also enable faster issue resolution and continuous improvement, ultimately leading to higher product quality and reduced costs. </span>

Compliance and traceability

Ensure accurate, real-time documentation and easy audits.

Efficiency and automation

Reduce manual paperwork and speed up data collection.

Quality and cost reduction

Improve product quality and lower compliance costs.

The impact of eDHR systems on quality and efficiency

eDHR systems significantly enhance quality and efficiency by automating data collection and reducing manual entry errors. They enable real-time monitoring and analysis of production data, leading to quicker identification and resolution of issues. This automation not only improves product quality but also accelerates production timelines and reduces costs associated with compliance and audits.

eDHR on Connected Work Cell (CWC) application

The eDHR software solution seamlessly integrates step-by-step digital work instructions, configurable operator process flows, and real-time control characteristic evaluation. This ensures the DMR process is meticulously followed, with all necessary information collected, legible, and instantly accessible in a digital format. Every interaction and data entry in CWC is managed by configurable permissions and a certificate system, providing precise control over the authority to execute each step in the DMR process.

Key features

Parallel user execution: Enhance efficiency with multiple users executing tasks simultaneously.
Onscreen user feedback: Receive immediate feedback to streamline operations.
Server-to-server promotions: Ensure only approved instructions are used in production by seamlessly supporting separate development and production systems.
Performance data collection: Gain insights into operational efficiencies through time-based performance data.
Real-time visibility: Monitor the progress of in-process DHRs and access immediate eDHRs upon completion for quality review.

GXP readiness

The eDHR-CWC solution is designed to meet GxP (good practice) standards, ensuring compliance with the FDA’s 21 CFR Part 11. This regulation outlines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Key solution features that support GxP readiness include:

QA reporting per device/batch: Detailed quality assurance reports for each device or batch ensure that all products meet stringent quality standards.
Operator authentication: Secure authentication processes verify the identity of operators, ensuring that only authorized personnel can perform specific tasks.
Secondary sign-offs: Additional layers of verification for critical steps enhance accountability and compliance.
Mandatory step completion: Ensures that all necessary steps are completed before proceeding, preventing any omissions in the process.
Audit trails: Comprehensive audit trails track all changes and actions, providing a clear history of who did what and when.
Electronic signatures: Compliant with FDA requirements, electronic signatures are used to authenticate records and approvals, ensuring data integrity and nonrepudiation.

PTC provides CWC customers with a premade documentation bundle to accelerate adoption and GXP validation efforts. This documentation includes templates, guidelines, and best practices to help manufacturers quickly achieve compliance.

Built on the robust ThingWorx platform, the solution allows for seamless integration with existing systems. It can be enhanced with additional features to meet unique requirements. System endpoints are available for quick integration with ERPs, PLMs, LDAP, and certificate management systems.

Explore ThingWorx

Connected Work Cell eDHR key features

Key features of the CWC eDHR solution include:

Quality assurance report providing comprehensive data for every execution against the DMR.
Authenticated operator ensures operations are only performed by trained and authorized operators. Secondary sign-offs assure the four-eyes principle as needed per GMP.
Multiuser execution allows the execution of multiple tasks in parallel.
Feedback can actively be gathered, encouraging operators’ engagement in DMR authoring.
Server-to-server promotion supports the need for separating development and production systems, allowing that only tested and approved instructions are used in production.
Validation against GMP with a premade documentation bundle helps to accelerate adoption.

eDHR frequently asked questions

What’s included in an electronic device history record?

An electronic device history record (eDHR) includes comprehensive documentation of the entire production process of a medical device. This encompasses manufacturing data, quality control results, testing and inspection records, component and material traceability, and compliance with regulatory standards. It also includes operator and equipment information, environmental conditions during production, and any deviations or nonconformances encountered and their resolutions.

What’s the difference between a DMR and an eDHR?

A device master record (DMR) is a compilation of all instructions, drawings, and specifications required to produce a medical device. It serves as the blueprint for manufacturing. In contrast, an electronic device history record (eDHR) is a detailed log of the actual production of a specific device, documenting each step taken according to the DMR. While the DMR outlines the “how-to,” the eDHR records the “what was done” for each individual device.

What are some common challenges in the DHR process?

Common challenges that medical device companies experience in the device history record (DHR) process include ensuring data accuracy and completeness, managing vast amounts of documentation, and maintaining compliance with regulatory requirements. Manual data entry can lead to errors and inconsistencies, while paper-based records are prone to loss and damage. Additionally, integrating data from various sources and systems can be complex, and ensuring real-time updates and traceability can be difficult without a robust eDHR system.

Does CWC meet all the critical requirements for DHR?

eDHR-CWC offers a comprehensive solution that integrates seamlessly with existing manufacturing systems and processes, ensuring a GxP validation-ready execution and recordkeeping system compliant with the FDA’s 21 CFR Part 11. Key features include:

QA reporting per device/batch: Ensures detailed quality assurance for each product.
Operator authentication: Verifies the identity of operators to maintain security.
Secondary signoffs: Adds an extra layer of verification for critical steps.
Mandatory step completion: Guarantees that all necessary steps are completed for full compliance.

These features ensure complete compliance, accountability, and information recall. To accelerate adoption and GxP validation efforts, PTC provides CWC customers with a premade documentation bundle.