The Remote Audit–A Tongue-in-Cheek Memo

Pharmaceutical Technology, Pharmaceutical Technology, November 2021 Issue, Volume 45, Issue 11
Pages: 66

Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.

Because of the COVID-19 pandemic, many companies no longer permit on-site audits. This has many advantages for the audited company (the auditee). This article tells how a company could explore this opportunity to its maximum advantage.

Memo to all staff

In order to make customer audits as efficient and effective for us, we have decided to update the respective standard operating procedure. Here we summarize the key elements:

  • From now on, we will only allow virtual audits or questionnaire audits, but no on-site audits.
  • These audits are limited to normal office hours (i.e., between 9 am and 4.30 pm with a one-hour lunch break from noon to 1 pm). Extensions are not possible.
  • We will only participate in Microsoft TEAMS video conferencing sessions that we have set up.
  • We do not allow parallel sessions (e.g., for more than one auditor).
  • There will be only one person from our company (the moderator) participating in the audit.
  • Any questions from the auditors that the moderator cannot answer, will be forwarded to the relevant subject matter experts (SMEs). The audit will be paused while the moderator types the emails to the SMEs.
  • The moderator will relay answers from the SMEs to the auditors as and when these are received.
  • If the moderator has been in contact with a person infected with COVID-19, the audit will be cancelled. Cancellations should not be sent out more than 24 hours before the start of the audit.
  • Documents can be reviewed in a data room during audit hours only.
  • For data protection reasons, anything we put in the data room, like the company presentation, will be non-editable, non-printable, and the “print screen” function will be disabled.
  • Documents will only be shared with the auditors through the data room.
  • Auditors can either access the data room to look at the documents, or they can access the video conference with the moderator. Parallel sessions are disabled.
  • For privacy reasons, we cannot switch on video on our side.
  • Virtual site tours cannot be conducted live. We will prepare pictures that will serve as a site tour.
  • For privacy reasons, the pictures for this virtual site tour cannot show any personnel.
  • The pictures for this virtual site tour will be available in the data room. No other pictures can be provided.
  • Only questions received during the audit will be answered.

Summary

Audits can be so much more relaxed and enjoyable because virtual audits have become commonplace. If this memo seems familiar, then this is pure coincidence.

About the author

Siegfried Schmitt is vice president, Technical at Parexel.

Article Details

Pharmaceutical Technology
Volume 45, Number 11
November 2021
Page: 66

Citation

When referring to this article, please cite it as S. Schmitt, “The Remote Audit–A Tongue-in-Cheek Memo,” Pharmaceutical Technology 45 (11) 2021.