Just as hospital procedures and healthcare practices must be documented and audited to protect patients, the manufacture of medical devices requires stringent record-keeping to ensure quality, safety and regulatory compliance. Whether it be an X-ray machine, patient monitor or implanted medical device, ensuring that these devices are produced according to the latest specifications not only prevents costly recalls but also safeguards the health and safety of the patients who use them.
An electronic device history record (eDHR) allows manufacturers to collect and manage critical records required by the FDA to document the production of each device. By automating the data collection process for device history records, a device maker can more confidently achieve compliance with FDA current Good Manufacturing Practices (cGMP) requirements.
Bringing together all information about a device’s manufacturing and testing history, the eDHR tracks data to ensure the documented manufacturing process was followed. This includes the requirement that all components and materials approved for assembly into the product were the ones actually used, all tests passed, and that all workers involved in the manufacturing and testing processes were trained and certified on the required operations.
Traditional, manual device history record practices can be inefficient, leaving manufacturers vulnerable to error and at a disadvantage for being out of touch with changing technologies and increasing quality and traceability requirements. Until now, implementing eDHRs using on-premise software was also challenging and could take months, due to the complexity of integration.
Recent advances in cloud technology and software developed specifically for rapid eDHR deployment has significantly reduced the time and effort required to implement the collection of automated quality records. This new approach has high value during an FDA audit, for example, increasing the auditor’s confidence in the overall quality system at a medical device manufacturer.
Portrait of an FDA Audit
U.S. medical device manufacturers are intimately familiar with the requirements of FDA 21 CFR Parts 11, 210, 211, and 600. In particular, the focus on GMP, documenting and controlling processes, and testing for expected outcomes has become standard practice – though a burdensome one – for medical device manufacturers. When evaluating solutions for production environments, the challenge boils down to how manufacturers can credibly demonstrate they have a solid manufacturing quality system in place.
During an FDA audit, the ability to produce correct, clear and verifiable quality records in a timely manner is essential. Implemented properly, the right cloud manufacturing solution can provide the structure for, and ensure compliance with, key elements of the FDA QSR (Quality Systems Regulation). For example, a leading OEM of class 2 medical devices had outsourced production of its products to Sanmina, a well known contract manufacturer of medical products. The FDA was expecting to see device history records for production of high volume medical devices built within a certain date range, along with test and parametric data for specific products and training records. Typically, an auditor asks for these records and expects the manufacturer to retrieve paper records from offsite storage. This can take up to a day.
Using cloud manufacturing technology, electronic device history records from a specific date range were delivered to the auditor in minutes, since they were all online in an easily searchable database. The auditor had visibility into training records that were also electronic with linkages to Product Lifecycle Management software, and was able to confirm that the production operator was trained to the latest revision of the procedures. The speed at which the requested information was produced, along with the quality and consistency of the records, resulted in a successful audit.
Medical device manufacturers now have a solution that helps automate day-to-day compliance of medical device production and provides a complete electronic record of how a medical device was produced. These records become part of a searchable database that can be queried a month, a year or five years later. The benefits of eDHR and cloud-based manufacturing software for production environments are clear to companies who have adopted this technology over the past few years. This technology also helps prove that processes for medical device manufacturing meet the complex needs of manufacturers in highly regulated industries and ultimately benefits patient safety.
About the Author
Srivats Ramaswami, Chief Technology Officer at 42Q, has worked at both OEM’s and contract manufacturers, most recently as vice president of IT Operations. His expertise includes the architecture and implementation of IT solutions, making the global supply chain visible and more efficient. Srivats is now responsible for customer acquisition and engagement, technology development and deployment for 42Q.