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42Q introduces Rapid eDHR cloud solution for medical device manufacturers

Published 09 May 2018

Cloud manufacturing software provider 42Q has launched Rapid eDHR, a solution that enables medical device manufacturers to rapidly 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:

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.

42Q CTO Srivats Ramaswami said: "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.”

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

Source: Company Press Release