Remote Auditing versus On Site Auditing: For the last 16 months the pharmaceutical world has had to get used to remote auditing as opposed to auditing in person.
Remote auditing meaning that you contact the auditees through a webinar tool online and usually there is a shared folder for access to documentation for review. For auditing both GMP and GDP facilities, there is often a short video or sometimes the auditees walk around with a camera on their company iPad.
I believe remote auditing brings up more negative issues than positive issues.
Some of the positives of remote auditing are:
Not having to travel and having longer in your jim-jams or being able to make an early class at the gym.
Not being subjected to a terrible breakfast in a mediocre hotel.
You can request information/documentation upfront and spend longer reviewing it if you require.
Some of the negatives of not being able to audit on site:
Not being about to travel (I miss flying! – the shopping at the airport, the wine on the plane).
Keeping your dog from barking at the postman and disrupting the audit.
Overloading the wi-fi during school holidays or remote learning and having to politely yell at the children to give up their share.
On a more serious note, I think it does make a big difference not being able to see people in person and not being able to audit the site with your own eyes.
It can take a long time to get the documentation you request during an audit uploaded and for you to download it.
Some shared folder platforms are much easier to orientate than others – Sharepoint is very user friendly.
Some companies will not let you review documentation beforehand and expect you to read documents on the screen whilst they move the document up and down during the audit – this is exceptionally time consuming and frustrating.
The short video of the facility offered is often from several months ago and could bear no resemblance to the facility at the time of the audit.
Delaying tactics are easier to use via the screen than in real time on site.
It is much easier to see what is missing and gauge people’s reactions in person. You are not able to get the same rapport through a screen. Part of auditing is giving confidence to nervous auditees and ensuring they stay on your side – I find this easier when I’m sat with someone in person rather than through a webinar tool.
Some top tips:
Ask to do a dummy run beforehand to check the link works.
Ensure your computer is fully charged and you have all the correct connection instruments.
Have two screens – you can keep an eye on the auditees on one whilst reviewing incoming documentation on the other. Ensure the NDA / confidentiality documentation is signed beforehand to save time.
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