Travel has been restricted due to the Corona Virus and many companies have turned or will be turning to alternatives to complete their audit schedule.  Remote Auditing is one of the alternatives to re-scheduling an audit.

So what are the essentials for a good remote audit?

The FDA, as part of the Medical Device Single Audit Program (MDSAP), has provided some guidance (Document No. MDSAP AU P0036.001, Effective 13 Jan 2020) which is of course directly applicable to a Medical Device Audit, but the concepts are are also very adaptable to Pharmaceutical audits of API facilities, CMO’s, Supplier, and Vendor Audits.  Essential Concepts:

Preparation:

  • Request information from the auditee to be submitted prior to the start of the remote audit.  This includes Quality Manuals, SOP’s, Org. Charts etc.
  • Ensure the technology for the remote audit is agreed upon and tested  Examples of technology available are:  Webex, Zoom, Facetime for tours and other options for video conferencing.
  •  Ensure web meeting invitations are sent with ample time for each party to plan conferencing and conference room space.
  • Confirm the appropriate personnel are available and scheduled for the audit.
  • Request a virtual tour be set up for a facility tour or detailed facility presentation by the auditee.
  • Audit Plans and Agendas can be set up as normal.
  • Time normally scheduled for a facility tour should be used to view an online virtual tour or presentation provided by the auditee.
  • Confirm the documents pertaining to the audit are readily available.  Use websites such as box.com for providing access to documents.
  • Ensure at least one or two auditee personnel are dedicated to supporting the audit over the designated period.

Performing the Audit:

  • Conduct the audit as closely as possible to an onsite audit.
  • Hold opening meetings with appropriate personnel using the video conferencing tool agreed upon.
  • Request a virtual tour of the facility or a facility overview presentation be provided with pictures following the opening meeting.
  • If many of the documents and records are made available ahead of time or via a website service such as box.com then the auditor can proceed with document review.
  • Questions and requests can be made via chat, email, phone, or online web conferencing.
  • If the auditee does not make the documents available for the auditors review, then documents and records will need to be shown via the video conferencing tool being utilized.

Closing:  The closing meeting should be held as normal but via the video conferencing tool selected.  Ensure that this meeting has been planned and scheduled ahead of time with the proper invitees.

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