SAN JOSE, CALIF.— May 8, 2018 — 42Q, a leading provider of cloud manufacturing software, today announced the release of Rapid eDHR, a solution that enables medical device manufacturers to quickly implement all electronic device history records (eDHR) in as little as three weeks. Leveraging 42Q’s secure cloud MES (Manufacturing Execution System) platform, medical executives using Rapid eDHR have instant online access to hyperlinked component traceability data and other quality records, enabling them to quickly respond to potential issues and optimize processes for improved compliance.
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:
“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.”
The Rapid eDHR functionality includes:
The 42Q Rapid eDHR solution is available immediately. For more information, please visit https://www.42-q.com/starter-kit/rapid-edhr-solution/
42Q is a leading provider of cloud MES solutions, implemented in over 50 manufacturing facilities. 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 on 42Q, please visit https://www.42-q.com/ and follow the company on LinkedIn.
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