Complex medical instruments including diagnostic imaging equipment and blood analyzers, along with high-risk medical devices like implanted pacemakers and defibrillators, are manufactured with comprehensive quality systems compliant with CGMP (current good manufacturing practices) requirements, found in 21 CFR part 820 of the FDA’s quality system regulation. The FDA audits manufacturing facilities that produce finished medical devices. During an FDA audit, the ability to produce correct, clear and verifiable quality records in a timely manner is essential. Rapid eDHR provides instant online access to medical device history records. This capability can be implemented quickly and is an important first step to rolling out an MES solution that provides the structure for, and ensures compliance with key elements of the FDA QSR (Quality Systems Regulation).
The 42Q Rapid eDHR cloud solution can electronically track and maintain extensive documentation and quality records pertaining to the production of finished medical devices. To date, some medical device manufacturers have been reluctant to transition from paper-based DHR processes to the electronic acquisition and storage of records, due to the complexity and time required to roll out on-premise eDHR systems.
Key benefits of the 42Q Rapid eDHR solution include:
- Fast, simplified implementation. Because it is cloud based, Rapid eDHR can be rolled out in as little as three weeks and isn’t dependent on complicated integration with legacy software platforms
- Instant visibility for improved compliance. Manufacturing executives and other personnel can instantly retrieve production data including component traceability data, test data and other quality records – from mobile or desktop computers at any location
- Built-in certifications and regulatory compliance. Rapid eDHR digitally records quality records in accordance with Good Manufacturing Practice (GAMP5) guidelines set forth by the International Society for Pharmaceutical Engineering (ISPE). 42Q and Rapid eDHR are also used today in facilities producing class 2 and class 3 medical devices with UDI (universal device identifier) labeling
“The simplicity of deploying Rapid eDHR is a radical departure from the complicated, on premise manufacturing execution systems of the past. It can help medical manufacturers transform compliance management,” said Srivats Ramaswami, CTO at 42Q. “Our medical customers say that having real time access to critical quality records during FDA and notified body audits also inspires a sense of confidence from auditors in a company’s overall quality system.”
Rapid eDHR functionality includes:
- Material verification and tracking, including traceability functions
- Employee verification and tracking
- Forced process routings
- Online work instructions
- Complete device history and genealogy
- 42Q Live and real-time operations dashboard
The 42Q Rapid eDHR solution is available immediately.
42Q is a leading provider of Cloud manufacturing solutions, implemented in over 60 manufacturing facilities globally. Our mission is to deliver scalable, flexible and easy to implement manufacturing solutions to our customers. Our management team has extensive experience with the architecture, development and implementation of advanced MES and manufacturing automation systems deployed across a broad range of vertical markets. 42Q is a business unit of Sanmina Corporation. For more information visit 42Q's Website.