In this podcast we focus on virtual audits as we speak to Dave Schumacher who oversees the Alturas Analytics Quality Assurance Program (ID, USA). Dave discusses his experience of virtual audits particularly as Alturas Analytics conducted one of the first virtual audits that included an FDA inspection.
About Dave Schumacher, RQAP-GLP
With over 20 years in Quality Assurance, David Schumacher, RQAP-GLP since 2004, oversees the Alturas Analytics Quality Assurance Program. David is an experienced Quality Assurance Professional in FDA regulated environments and auditor in numerous analytical techniques. His emphasis is in bioanalytical (LC−MS/MS and ligand binding) and formulation assays.
With a strong laboratory background, David is known for his GLP auditor skills specializing in analytical sciences. His attention to detail and contributions to the Alturas QA Team add significant value to Alturas Analytics. He is considered by his colleagues to be a mentor and a source of regulatory insights. In the community on a volunteer basis, David provides safety communications for a number of special events as a licensed Ham radio operator to prepare for actual disasters where other forms of communication may not be available.
Questions discussed include:
Q) How have remote audits been accepted by sponsors?
I think sponsors have adapted. They have been forced to adapt in some ways. So, it has been an interesting time-period to get these remote audits figured out, figure out platforms, figure out systems that work, that don’t work and technology can be wonderful or it can be a bane as well too trying to get things setup and working. You know, occasionally, we have come into last minute glitches and so we just figure it out and we move forward. For the most part the industry has accepted remote audits at least in our environment. We recognize that remote audits don’t solve everything for all the scenarios and companies out there, but short of not doing anything at all, companies are trying to make this work.
Q) Is preparing for a remote audit any different than an on-site inspection?
Well, the way we run our remote audits, there is a lot more prep work I think. It takes more time and more effort to get the system setup. You know, it is going to depend on each company, what tools they have available. Some companies may have an auditor to log directly into their quality management system and have all their documents and everything like that there. We don’t quite have that. We save all our key documents, our SOPs, training files whatever into a PDF format and then we upload them to a secure site and then give access to the secure site to the auditor. Well, you know, that sounds fairly easy, but if you have a 100 or 200 SOPs where you had to make sure you had the right version number there, you know, if there are any changes to SOPs, a new version of the SOP or document coming out, during the audit you need to upload that at that time and inform the auditor.
With remote audits, one of the challenges that you have too is, what time zone are people in? Basically, here in my company we are a 8-to-5 shop like most companies are, but if you are in the east coast or overseas, well, now you have some challenges. We don’t have many overseas customers, so our audits have been in the US. But if we are in pacific time zone here and we are dealing with east coast time, well, starting at 11 o’clock their time is not helpful. So, we try to find half medium, setup a time where it facilitates both of us and deal with the time zone issues the best we can. It’s important just to communicate upfront when you are setting up the audit – how is the audit going to transpire when we are first contacted by the auditor, “Hey, we need to do an inspection” and my response back to the individual, I go into pretty good detail as to how the audit is going to lay out, so they can plan in their mind how this is going to play out because this is not a standardized process by any means yet.
It’s important for the auditor to understand how this is going to work so they can plan their schedule accordingly. So, something what we have done here is actually prior to the audit, we will give the auditor access to the secure website with all our documents about 5 days before the actual audit. It gives them the chance to go and review processes, SOPs and some training files. So, when we actually do have the online audits, using Zoom or WebEx or whatever platform we are using, the auditor can come in with questions right away and we make it efficient.
Q) Are there any limitations to a remote audit?
Well, one of the areas that we find a little bit limiting is the ability to actually look at raw data, to look at say an LC−MS/MS, chromatogram files, the data acquisition, the LIMS system and we cannot upload that. So, we will generally do a shared screen at that point and scientists on our end will bring up any files that the auditor wishes to see. We can show the electronic files right on screen. You can ask questions. Obviously, it slows things down a little bit, but for the most part, our customers have been understanding and they are thankful and acknowledge those limitations. So, the primary limitation is just to be able to look at some of the electronic data in the live format. For the most part, it works well on our side.
You mentioned that we hosted the FDA. You know, we were one of the first companies in the US and actually internationally almost too to be inspected remotely by the FDA and we shared a number of files with them online remotely. They actually controlled the platform WebEx, but they would give control of the screen to us and then we would navigate through all the data with them. So, that process went on for multiple days and I am sure most people out there are glad to know now that the FDA actually doesn’t do remote inspections anymore, at least not officially. They are called remote regulatory assessments. They are not official inspections but go through all the functions that they normally would, except that there is no 42 or 43 as part of that process. But if they do have questions it is best to address them because when they do get around to a live inspection, they will be coming and following up on those.
Q) What tools have been helpful in conducting a video tour?
We do our tours using just a cellphone. It’s handy. You can hold it in your hand or actually what works better is a handheld gimbal device that helps stabilize the camera. The gimbal also allows you to go from landscape to portrait mode or use it to pan. It takes out a lot of the vibration that you might normally get from just holding it by hand. Another tool that we have just recently implemented, is that we do our tours with two people. We like to put the senior scientists, the individual who actually is leading the tour out in front of the camera. So, the senior scientist does the narrative. We try to make our tour as interactive as possible, so the auditor can ask questions.
We have a Bluetooth speaker device that senior scientists carry. Actually, it’s a speaker phone design for our conference room. It’s just a flat device, maybe 5 inches in diameter, but we mounted it to a platform and then put a handle on the bottom end. So, now the senior scientist is holding it like a speaker, then he or she can easily hear any questions the auditor maybe asking. The handheld gimbal and the speaker phone, they cost each about a 100 bucks or something like that but they are well worth the investment.
Q) Are remote audits here to stay?
I think remote audits will be around now for quite a while. They obviously are not the ideal tool sometimes, but companies have figured out how to use them and understand what the limitations are. A good auditor is going to use all of their senses when they go into a facility, not just visual. The on-site audits are still going to be important moving forward. But perhaps, we will have an on-site visit every 2 years or so or maybe they will do an on-site every other year or skip a year, then do a remote audit in between. If they are comfortable with the facility and they are confident that there is no huge questions or issues, they may decide to do a remote inspection instead. So, yes, I think they are going to be a tool that auditors will continue to use even once this pandemic is over.