Prior to COVID-19, the Medical Device Coordination Group (MDCG) required all audits to be performed onsite. Then MDCG approved the use of remote auditing in specific cases to help the industry continue supplying medical devices during the pandemic. With approval to conduct audits remotely, it’s quickly becoming commonplace.
In the short-term, limited ability to conduct traditional onsite audits by manufacturers, notified bodies, and health authorities has introduced an additional layer of complexity and made remote auditing a necessity for companies and quality consultants. Longer-term, remote auditing is a significant opportunity for industry to further streamline quality processes and supply chain continuity.
Companies with modern quality management systems have been in a much better position to make the switch to remote auditing. These organizations have minimized supply chain disruptions while ensuring safe and effective products are available to healthcare professionals and patients.
But a modern, cloud-based system is only one piece of the puzzle. For audit groups looking to make a fast shift to remote auditing, here are tips to prepare and what to expect.
Put the Foundation in Place for Remote Auditing
There are several foundational components required before an audit group can make the switch to remote auditing. With the necessary digital tools and processes in place, medical device companies can be ready to conduct a complete and effective remote audit.
Standardize on the right remote meeting technology: A high-quality collaboration platform is key to conducting a successful live virtual meeting. The right remote meeting technology should provide a secure and seamless user-friendly experience. Consider the preferences of your auditors—the more familiar individuals are with the collaboration tool, the more successful the digital meeting will be. If teams aren’t experienced with the platform, make sure there is proper training. In addition to the virtual meeting platform, be prepared to support live file sharing and provide real-time video tours of manufacturing or production areas, if required.
Get a stable, secure connection: A high-bandwidth internet connection is critical, especially now that many people are working from home. Confirm all participants are connected through a stable and strong wired or wireless network. A large file transfer has the potential to knock every party off the network, causing delays and frustration throughout the remote auditing process. Additionally, ensure the network is secure to prevent any unauthorized access to your remote audit meeting and files.
Have a support team ready to help: Staff members should be available and ready to support auditors virtually as they would in-person, onsite. Plan and discuss the remote audit plan well in advance and assign specific tasks and responsibilities such as filming a virtual manufacturing tour or scanning documents. Remote auditors could be based in different time zones, so the support staff’s working hours may require some flexibility. Once the plan is in place, rehearse the audit to identify potential glitches and swift resolutions. Prepare a contingency plan for communication failures, including direct phone numbers for all participants and an IT expert who can troubleshoot issues quickly, if necessary.
Implement a content management system for seamless information access: A modern content and data management system is key to giving internal teams and external auditors simple connectivity and digital access that can help ensure the long-term success of remote auditing. User-friendliness is a primary consideration—the system should be easy to navigate with little or no training required. Strong encryption and proper security certifications are also important to ensure the data integrity, privacy, and confidentiality of a remote audit, as well as give auditors the proper level of access. A cloud-based solution provides a centralized location for documents, leveraging “binders” organized by specific need or use case instead of a conventional folder structure approach that makes it difficult to maintain and find the right content. This allows you to organize the in-scope content needed for the audit while providing access to only that binder, which helps both auditors and auditees collaborate more efficiently. Exchanging documents for management review, internal audit reporting, and findings is easier and seamless with a modern system.
Looking Ahead: Streamline Quality with Remote Auditing
Remote auditing accelerated significantly this year and, moving forward, it will become a more important component to quality processes, even when travel and onsite restrictions are lifted. As medical device companies implement the technologies and processes mentioned in this article to foster digital and remote working, remote auditing will take hold in the medical device industry.
Virtual meetings are now commonplace and much more seamless. People rely on videoconferencing to get work done. This reliance and familiarity will be useful when training audit staff members digitally and significantly ease the transition to remote auditing as the new normal.
As teams get used to these new ways of working, not only will they become more skilled at interacting in real time with auditors, they’ll also turn into experts using different, modern digital tools to share information. The lack of face-to-face, in-person interactions will no longer be a hindrance.
Remote audits will ultimately drive greater efficiency versus traditional paper-based processes, which require manually digitizing and transferring of records. Not only will auditors be able to access required files more easily, collaboration with internal teams will improve. Teams can more easily oversee suppliers and work together across multiple disciplines such as regulatory, quality, and clinical.
When content and data are stored and accessed in one central digital application, information sharing is simplified and the need to find and update multiple files in different systems for audits is eliminated. A digital system like QMS, for example, also makes it easier to revise existing procedures to include remote auditing.
Looking ahead, remote auditing will continue to gain momentum and more organizations will embed it as a new way of working. The traditional onsite audit will become less frequent. Now is the time for manufacturers and suppliers to explore their capabilities to conduct remote audits. This will not only address short-term needs during COVID-19, but also create a much more efficient and sustainable model well into the future.
Seth Goldenberg is responsible for Veeva Vault strategy in the medical device and diagnostics industry, including customer engagement, market adoption, and product development. Goldenberg has nearly 20 years of experience supporting medical device and diagnostic companies to navigate complex regulations and improve market access. Before joining Veeva, Goldenberg was director of product development strategy at North American Science Associates (NAMSA), where he supported medical device companies from inception through commercialization and post-market activities. Outside of Veeva, Goldenberg is an active member of the Regulatory Affairs Professionals Society (RAPS) and is the “entrepreneur in residence” at the Pennsylvania Pediatric Device Consortium. He holds a doctorate in pharmacology from the University of Washington and a master’s degree from the school of biomedical engineering at Drexel University. He can be reached at firstname.lastname@example.org.