The virtual inspection software created by CloudVisit is well suited for conducting quality audits of manufacturing facilities for a variety of industries. Similar collaborative technology has been widely adopted by the energy and telecom industry for years to improve their business and quality control processes. This new technology has finally also caught the Food and Drug Administration’s (FDA) attention. As a result, the FDA established a pilot program on January 10, 2020. Given the current health and safety issues associated with travel during the Covid-19 pandemic, the timing really could not be better. Medical device manufacturers can now revisit the way they conduct site inspections of their facilities. Navigating governmental regulations can sometimes be difficult. Fortunately, CloudVisit Remote Inspection software is the perfect solution for medical device manufacturers to work within the Medical Device Single Audit (MDSAP) remote audit pilot program.
About the FDA’s Medical Device Single Audit Program
The MDSAP remote audit Pilot Program was initially slated to last eighteen months. However, the FDA left room for the pilot program to be extended beyond this initial trial period. Given the state of the global pandemic, there is a high probability that the pilot program will be extended. The pilot program is completely voluntary, and it allows Medical Device Manufacturers to utilize new collaborative technology such as CloudVisit Remote Inspection software for remote audits. To take part in the Pilot Program, companies are required to conduct a survey to evaluate the pilot program. Due to Covid-19, the FDA has expedited the use of remote audits for medical device manufacturers.
What qualifies for a remote audit?
The FDA has deemed that there are certain cases when remote audits can be used. For example, facilities with a good record of conformity may have their surveillance or recertification audits substituted with a remote audit. Remote audits can also be used to address transfers between audit organizations if a facility also has a long history of conformity.
Medical Device Manufacturers are eligible to use remote audits to address changes or transfer between Audit Organizations when they meet any of the following criteria:
- The audit represents the addition of an activity and the activity can be successfully audited remotely
- The audit is to review the addition of a medical device and the device represents a similar risk profile to the previous existing device’s in the scope, and the new device uses existing production technologies and facilities
- The audit is required due to an additional regulation
- The audit covers the expansion of an existing production facility if the expansion is within the existing production environment and technology and does not involve an additional site or facility
- The audit is the result of a change in ownership
- The audit is for a change in critical supplier, and the new supplier does not require an audit
How CloudVisit Remote Inspection Software meets the policies and procedures required by the MDSAP remote audit pilot program
Audit organizations are permitted to use remote audits after establishing that policies and procedures meet a predetermined list of requirements defined by the MDSAP. The good news is that CloudVisit Remote Inspection software meets these requirements with a long list of features specifically designed for remote audits and inspections.
The MDSAP’s remote audit pilot program requires the ability to schedule the remote audit. CloudVisit’s software is flexible enough to track the duration of a scheduled audit. In addition, the platform’s scheduling functionality allows you to define the roles of the auditors, auditees and regulators. Robust user roles and permissions also help to ensure that only appropriate people can gain access to data regarding the remote audit.
CloudVisit Remote Inspection provides a secure connection for a facility and an auditor to conduct a remote video inspection, as required by the pilot program. The software provides a high definition audio/video user experience with excellent video quality. This allows offsite auditors to be fully emersed within the remote audit, providing an experience that is as close to being onsite as reasonably possible. The software further meets the remote audit pilot program’s requirements by being specifically designed to perform remote audits. Aside from features available in most video conferencing systems like screen sharing, CloudVisit also includes checklist functionality so that the auditor can follow a well-defined audit plan.
What good is a quality management system if it does not provide the ability to securely store relevant documentation related to an audit plan? The FDA recognizes this necessity and therefore, the remote pilot program also requires secure document storage. CloudVisit’s platform, allows you to document, store and track audit status values for things like non-conformity, as required by regulatory agencies. CloudVisit Remote Inspection software allows Medical Device Manufacturing companies to store important documents in a session file folder. For example, you can store a F0019.2: Nonconformity Grading and Exchange Form along with any other standard documentation in the file folder. You can also store the completed Audit Reports to be directly linked to a Device Marketing Authorization Facility Registration (DMAFR) report. It can then be easily, retrieved, and shared with a regulator, a customer, or a facility manager.
The MDSAP remote audit pilot program requires guaranteed uninterrupted access to the connecting software system. To assure this, CloudVisit Remote Inspection provides diagnostic speed test functionality directly to native servers for both desktop computers and mobile devices. These tests determine the amount of available bandwidth and level of latency between the client device and the cloud hosting environment. The speed tests aid in identifying medical device manufacturing facilities that are good candidates for remote audits. The FDA requires test sessions prior to the remote audit. CloudVisit recommends running the speed test function during the required test session. This helps to ensure that your remote audit is a total success.
Final thoughts on the FDA’s remote audit pilot program
The FDA has finally begun to explore the cost and time saving opportunities for utilizing remote audits. This may be a new concept to the FDA, but it is old hat to CloudVisit. When we were first tasked with creating Remote Inspection, it was because CloudVisit already had an established telemedicine platform. There is a direct correlation between a virtual inspection and a virtual doctor’s appointment, if you think about. Therefore, the fact that medical device manufacturers are finally beginning to see the value of remote auditing, is completely unsurprising. The healthcare industry has been using remote audits in a more individualized format for the past ten years.