Do you use audio-visual streaming during FDA inspection?
- Thread starter SGquality
- Start date
I've never used video camera for inspections/audits and I'm not sure it would be worthwhile.
Last inspections/audits were multi-inspector/auditor, with several scribes and evaluations being performed at the same time. We did have one scribe for each inspector/auditor, and we used a Google Hangout stream for requests and information sharing. Monitors in the War Room (and other places, in fact we noted that people were just so interested and delighted with this that they simply keep following what was going on during the whole time
) were on the Hangouts stream, and there's were already plenty of information. I think a video would only make things more confusing (we did have some eyes for when inspector/auditor went out of the room, but they simply sent updates thru Hangouts or WhatsApp).
Last inspections/audits were multi-inspector/auditor, with several scribes and evaluations being performed at the same time. We did have one scribe for each inspector/auditor, and we used a Google Hangout stream for requests and information sharing. Monitors in the War Room (and other places, in fact we noted that people were just so interested and delighted with this that they simply keep following what was going on during the whole time
) were on the Hangouts stream, and there's were already plenty of information. I think a video would only make things more confusing (we did have some eyes for when inspector/auditor went out of the room, but they simply sent updates thru Hangouts or WhatsApp).
The use of webcams or audio recording is mentioned in INVESTIGATIONS OPERATIONS MANUAL (see section 5.3.5, on page 37 of 123), and states the following:
Under normal circumstances recording devices will not be used while conducting inspections and investigations. However, some firms are now recording and/or videotaping, the inspection and/or the discussion with management portion of the inspection. These firms should be advised we do not object to this procedure, but we will also record the discussion to assure the accuracy of our records. Occasionally a firm's management may record the serving of an inspection warrant or, in a hostile situation, may want to record everything. In such cases, depending on the circumstances, you may prepare your own recording in parallel with the firm's recording. Do not depend on the firm to provide a duplicate of their recordings.
Under normal circumstances recording devices will not be used while conducting inspections and investigations. However, some firms are now recording and/or videotaping, the inspection and/or the discussion with management portion of the inspection. These firms should be advised we do not object to this procedure, but we will also record the discussion to assure the accuracy of our records. Occasionally a firm's management may record the serving of an inspection warrant or, in a hostile situation, may want to record everything. In such cases, depending on the circumstances, you may prepare your own recording in parallel with the firm's recording. Do not depend on the firm to provide a duplicate of their recordings.
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