How do companies effectively share documents during a remote audit? What are some of the challenges that need to be overcome?
These questions were addressed during the May 18, Redica Systems webinar, Remote Audits, which featured a virtual panel discussion that included two of our Industry Experts, Senior GMP Quality Expert Jerry Chapman and Senior GMP Expert Barbara W. Unger. Pharmatech Associates, Inc. Executive Director of Regulatory Compliance Stephanie Gaulding was also a featured panelist.
Redica Systems Senior GXP Specialist Jason Kerr moderated the panel.
The following is a select Q&A examining documentation issues during remote audits. Part I looked at the current state of remote inspections and audits and Part II explored new technologies for remote audits and virtual inspections.
[Related: To download the full recording of the panel discussion, click here.]
When to Share Documentation for Remote Audits
Jason Kerr: If a supplier refuses to provide documentation ahead of time or limited documentation, and is only willing to show documents via screen share, how would you best utilize your time with these documents?
Barbara W. Unger: I can explain what I have done the couple of times that has happened—I have totally changed my plan. I do not read SOPs at that point. I drive them to go through the SOP and then show me the text.
Stephanie Gaulding: I would say I have actually seen situations where the person who was in charge of scrolling the document did not know where to find certain information, which is usually a little embarrassing on their part. Often in those situations, I have found out it was somebody who was assigned the job who actually was not super familiar with it.
I would say I tend to gravitate toward a very similar methodology where if you are going to control it that much from an auditee perspective, then as an auditor, I am just going to revert to asking a lot of questions. I just go in and ask them all the questions that I would want to know about that particular process and have them show me where in the various documentation it lives, or have somebody talk me through those processes.
Logbooks and Remote Audits
Jason Kerr: What about logbooks in terms of sharing? How do you review them remotely? And also for calibration records? Is it also using the same tool or have you seen or experienced other auditees sharing in a different platform?
Stephanie Gaulding: I think it depends on the nature of the records. There are companies out there that have a lot of that information in an electronic format. In that case, more traditional screen-sharing methodology works. In other cases, there are some devices that I have seen companies deploy that are basically similar to a traditional backlit overhead projector. You put a document on it, and it takes a live video feed of the document, we flipped through it and I could actually see them turning the pages.
Jerry Chapman: Actually, this is a little peripheral to what we are talking about, but I still think it is important if you are a company that decides you want to keep everything close to you, i.e., you are not going to share a document, instead, you are going to put it on the screen when they ask for that particular document.
You need to remember that that is a double-edged sword. Think of the traditional type of inspections and the way that you would host an inspection. There is a front room and a backroom. The front room is where the investigator is. The backroom is where your people are and the requests go through that backroom. They go to the backroom and say, ‘okay, they want to see this particular validation protocol.’ So, then the person in the backroom goes and gets it and the investigator reads it, and they look through it and they may have a question about it. Of course, you have to be prepared to answer their question.
(Editor’s Note: For more on what happens in the front room versus the backroom during an FDA inspection, read “The FDA Inspection Has Begun: Now What?”.)
But if you’re putting a document up live on the screen and the investigator says, ‘I want to see this validation protocol for selection,’ then there is the big potential for an issue as you have not gone through it yet. You are just putting that up there, almost like doing it live. It is really a double-edged sword that puts the company doing that at some risk. And I just think that is an important piece that we have not really touched on yet.
Use of Voice Transcription?
Jason Kerr: Does anyone use voice transcription tools to capture audit notes while reviewing SOPs and documents?
Barbara W. Unger: I have not. I have a couple of good friends who do use them and like them, but I think that becomes a real challenge because the auditee can then hear you. So you have to be very careful when you mute and do not mute. And if you mute it and your lips are moving, it raises the question of, are you asking them a question versus dictating to your phone?
Stephanie Gaulding: I am in the same boat that Barbara is. I personally have not explored that kind of technology. And I am going to be very transparent with everybody, part of it is, I have a hard enough time with voice to text on my phone and the accuracy of what it captures. I am not sure I want to trust that kind of technology with capturing my audit notes. I still take paper notes and keep things in a much more traditional way than maybe kind of investing in that technology.
[Editor’s Note: Part IV looks at the future of remote audits and inspections.]
[Related: To download the full recording of the panel discussion, click here.]
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