What is eDHR?
An electronic Device History Record (eDHR) is digital documentation of the manufacturing process of a medical device. An eDHR contains detailed information about the persons carrying out the work, the work steps involved, the production process and quality checks, as well as serving as proof of compliance with regulatory requirements.
Traditionally, this documentation has been created as a DHR in paper or document-based form.
As opposed to the paper-based process, digitized device history records make a decisive contribution to compliance with legal regulations, reduce the risk of errors and improve traceability. And they provide a comprehensive, accurate record of each product's production history, which is essential for quality assurance and regulatory audits.
eDHRs help to document the safety and efficacy of medical products. By providing a transparent and traceable record of the entire production process in real time, they support manufacturers in complying with strict regulatory standards such as FDA, GMP and ISO requirements. This transparency also provides the basis for identifying and solving emerging problems and continuously improving manufacturing processes.
Key disadvantages of paper-based DHRs
Most manufacturers in regulated industries such as medical technology still use paper or document-based processes to create their DHRs. Working with paper poses significant challenges:
- Compliance costs:The need for strict verification and compliance with rules and regulations often leads to high operating costs.
- Time to market:The time-consuming administration of DHRs can delay the market launch of new products.
- Penalties and image:Manual documentation is prone to human error and inaccuracies. This can have a negative impact on product quality and compliance with legal regulations.
- Possible consequences include penalties due to incorrect compliance with regulations, product recalls, safety issues or plant shutdowns.
- High operating costs:The storage and management of paper archives requires space and resources, which increases operating costs.
- Lengthy audits:Searching for information in paper documents is time-consuming, leading to inefficiencies and delays in audits and inspections.
What does eDHR software do?
eDHR solutions automate the collection, storage and retrieval of relevant data. By accurately documenting the production process in real time, eDHR solutions improve regulatory compliance, traceability and data integrity. By monitoring and analyzing production data in real time, they enable faster problem solving and continuous improvement - resulting in higher product quality and lower costs.
eDHR solutions ensure that all relevant information is accurately recorded and easily and quickly accessible for audits and inspections. Costs associated with compliance and audits are reduced.
Manual input errors are minimized while quality and efficiency increase significantly. Automation not only improves product quality but also shortens production time.
Key advantages of eDHR:
- Compliance and traceability: Accurate real-time documentation and simpler, faster audits
- Efficiency and speed: less paperwork, more speed in data collection, storage and retrieval
- Quality and cost reduction: higher product quality, lower costs for compliance with regulations
eDHR with ThingWorx
ThingWorx offers eDHR software as an extension of its Connected Work Cell (CWC) application. The comprehensive solution can be seamlessly integrated into existing manufacturing systems and processes.
The software complies with GxP (Good Practice) standards. It ensures compliance with the requirements of 21 CFR Part 11 of the FDA - i.e. the criteria according to which electronic records and signatures are considered trustworthy, reliable and equivalent to paper records.
eDHR and IoT, IIoT and xIoT
The ThingWorx platform helps medical technology companies make full use of the Internet of Things (IoT), the Industrial IoT (IIoT) and the extended IoT (xIoT) as well as modern technologies such as augmented reality and artificial intelligence. This enables users to achieve measurable benefits in many areas.
This is particularly true for medical technology manufacturers, as they struggle to comply with legal requirements and regulations, while under constant pressure to innovate, surpass competitors, elevate sustainability and remain profitable. At the same time, they must always maintain high product quality and ensure patient safety.
Renowned companies use ThingWorx to tackle these challenges.
- Pfizer improved its product yield, reduced energy costs and optimized the use of its facilities.
- Thermo Fisher increased its efficiency by 17 percent, thanks to digitized power control and the elimination of manual data entry.
Some medical technology companies have used ThingWorx to improve the performance of their devices or the associated service.
- Sysmex America integrated ThingWorx into a hematology analyzer for rapid on-site blood test results and faster diagnosis times.
- Elekta has connected thousands of devices worldwide using ThingWorx and can now monitor product performance in real time, improve device uptime for clinicians and increase treatment capacity for patients.
Download the white paper
Download the white paper to find out how your company can benefit from ThingWorx.
Download Now