Remote audit software for the medical device manufacturing industry

Medical device manufacturers can now conduct remote audits using CloudVisit Remote Inspection software. The FDA’s Medical Device Single Audit Program (MDSAP) includes a pilot for remote audits. CloudVisit Remote Inspection software meets the requirements of the Medical Device Single Audit Pilot Program.

CloudVisit Remote Inspection software meets the MDSAP pilot program requirements in the following ways:

  • Simplifying the planning of a remote audit by:
    • Providing the method and technology for conducting the Remote Audit
    • Creating automated email communication notifying responsible auditors, and auditees that the audit will be conducted remotely prior to the remote audit
    • Onboarding, identifying and informing the appropriate team members from the medical device organization who will participate in the remote portion of the audit
    • Identifying the remote auditor, utilizing user roles in the remote audit session’s details
    • Diagnostic speed test functionality, ensuring that a facility is a good candidate for a remote audit and guaranteeing uninterrupted access to CloudVisit Remote Inspection software
  • Providing robust scheduling functionality that can specify the duration of the audit, and adjusts to user’s time zones automatically
  • Providing dedicated permission levels and user roles within the software so that designated auditors, auditees, customers and governmental regulators have appropriate system and file access
  • Providing a secure communication channel between the manufacturing facility and auditor to conduct a remote video audit
  • Providing a HD real time audio/video conference user experience that allows auditors to inspect a site remotely, while emulating being at the production facility as realistically as possible
  • Providing screen sharing functionality within the video conference experience
  • Providing software with the sole purpose of conducting remote audits utilizing a checklist-based audit plan
  • Providing a means to capture documentation of any non-conformity uncovered during the remote audit, using defined status values in the audit plan checklist. CloudVisit Remote Inspection software also enables you to track and document any corrective actions that were undertaken after the initial remote audit was conducted
  • Providing storage of documentation related to an audit plan for as long as required by regulatory agencies. You can easily share or restrict access to documentation within a Remote Audit’s file folder
Remote audits by medical device manufacturers using CloudVisit Remote Inspection software

CloudVisit Remote Inspection Software provides dedicated functionality that far surpasses what is available in WebEx or Adobe Connect, which are listed as suggested example video conference platforms in the pilot program document MDSAP AU P0036.001.

For example, within CloudVisit Remote Inspection Software you can:

  • Import an auditing plan as a checklist to ensure that the site is fully reviewed in accordance with the plan
  • Record the entire remote audit for storage in the cloud or immediate download
  • Generate hyperlinked time codes within the recording so that you can immediately jump to appropriate inspection evidence upon recording playback. This is a real time saver for audit review
  • Track any deficiencies or non-conforming items within the audit’s documentation
  • Assign roles and responsibilities for system users within the audit
  • Easily export and download consolidated audit reports for distribution
  • Directly onboard, and manage user account permission levels within the software

Conduct remote audits using CloudVisit Remote Inspection software

Schedule a demo or get started with your first remote audit today.