Editorial | Open Access | Published 15th June 2021
EDITORIAL - A Permanent Remote World?
I have just loved working from home. I live on my own and working from home gives me the time and space to focus on just one thing at a time. I can also listen to background music of my choice all day!
Two years ago, this didn’t work. There were always extra snacks or some cleaning or minor domestic chore that seemed to creep into my brain and take priority. Now with a full home office set up, it feels like the correct place to work. What has also changed are the VPN connections, the accessibility of work files, home printers/scanners and the use of laptops rather than desk top computers.
I did not realise how all the constant interruptions, facilitated by open office areas, mean that your brain starts everything from scratch after each interruption. Most of the interruptions are work related and valid. However, from a personal work perspective, they reduce my work output significantly.
The use of systems such as Teams, inside and outside the office, means that communication is continued, albeit remotely. And to be honest Teams focuses the conversation. Most of the coffee room chat is gone. I personally welcome this, miserable antisocial person that I am! Teams is good for managing uninterrupted time as well.
I still do two days a week in the office. I try to reserve this for the day-to-day work where 1:1 in the flesh interactions are needed.
I really hope for my personal reasons and business reasons, that working from home stays as a permanent feature of the office environment. This is not an option for laboratory or manufacturing based personnel. As a QP I need to spend time on site to be able to understand the process.
We recently had a remote MHRA inspection. It worked very well, in fact the document recovery process worked far better than on previous inspections. We still have a paper based QMS system and I dreaded the document recovery process before the audit. The process of sending electronic copies in advance worked well. The process of getting documents to support a request on the day also worked a treat. The inspection was done on teams as well and the only hitch was the IT connection for document sharing – this was only a short delay.
The site tours were by camera and this wasn’t perfect as we had a couple of “no signal” spots. I believe that the tours are needed and that this will be reinstated but hopefully there will be hybrid audits in the future in which both remote and in-site inspections will be part of the future.
The inspection took longer than an on-site inspection but this too worked well. It was never the full day and we had more time to prepare for the next day. The GMP certificates arrived 2 days after the inspection was finished. Hopefully, the yellow embossed paper is gone for good.
A recent MHRA Blog¹ talked of 750 inspections conducted remotely during the pandemic. The future will include a combination of remote and in-site inspections, whatever is appropriate for both the site level of compliance and the criticality of the medicines produced.
“I have found the consensus view across global regulators is that working remotely is a great ‘tool’ in our inspection toolkit, but will never replace what can be achieved in person – and there are many areas that are just not suitable for remote approaches, such as sterile facilities”
Hopefully remote working and remote inspections are here to stay. For me personally home working is significantly more productive. For the MHRA it seems to be accepted as a new tool to be used where deemed to be appropriate.
1. Paula Walker 26 March 21 Inspectors Grounded – a year of innovation