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Covid lessons for pharma manufacturers and why SaaS EBR is part of the answer

Do you want remote access to your batch records? Want to be able to review and release batches from home? See this article on what the Covid pandemic has taught us about the relevance of SaaS EBR.
The current Covid 19 crisis is teaching us many things about ourselves. We are learning what’s important to us as individuals and families and we’re also learning lots about our working lives, habits and preferences. Many things have changed in our personal lives. Who would have thought our relatives old and young would adapt so readily to video conferencing as a way of keeping in touch or how much we’ve enjoyed getting out for exercise in our local areas. The changes in our workplaces have arguably been more dramatic.

Lessons from Pharmaceutical Manufacturing
Those of us who work in pharmaceutical manufacturing can be at least grateful that our industry has largely kept going through the pandemic and it is in these challenging situations when we realise how vital our industry is. Even if we never really forgot this, it brings it home to us in stark reality.

So what have we learned about pharma manufacturing during these last few months?

Well the obvious one, is more people working from home with the perhaps surprising aspect that is, how much people enjoy this and many don’t want to go back to the office. It seems also that employers who may have been reluctant to allow this before the pandemic have seen how efficient this can be and how hardworking and committed people have been in a way we may not have expected.

Secondly, how much we can get done using ‘App’ technologies such as Microsoft Teams and Zoom. A company I know thought they would struggle to carry on with their business as it relies heavily on workshops to analyse complex manufacturing processes and collaborate over improvements and optimisation ideas. By adding a whiteboarding tool such as Miro to a Zoom call they have found that their fully remote workshops can be better than before!

It’s clearly a good thing that individuals and companies are adapting, because we all want to be safe and ensuring only the minimum number of people are on site will help to do this. So the challenge is ensuring we can keep manufacturing our vital products whilst protecting our colleagues. Understanding who needs to be on plant and who could work remotely is key to achieving this. Clearly people who physically operate plant and equipment will need to be in the production facilities but who could we enable to work remotely? What about supervisors, managers, QC, QA? There are tools available that can help with remote monitoring and participation in the management of Batches such as review and approval processes.

How can we support remote working in pharma manufacturing?
If we look at one aspect of GMP manufacturing, namely production records, it is possible to execute production, review exceptions, approve the batch record and release for sale by the QP with most of the people involved working remotely. Tools such as cloud based Software as a Service (SaaS) electronic batch recording (EBR) systems enable this. The operators will need to be on plant and will complete the batch record in the system rather than paper. This then allows the supervisors and quality assurance staff to logon to the same batch record in real time and see how it is progressing and even respond to exceptions and deviations in real-time. At the end of production the batch can be reviewed and the QP can release for sale remotely with accurate and timely information from the EBR.

Future systems and tools
Solutions such as SaaS EBR, together with the video conferencing and collaboration tools already mentioned will become essential for us to make sure we can keep medicines being manufactured in these challenging times. It’s not just the current crisis that we need to consider. We are learning that threats we once thought unlikely can hit us very rapidly. Covid will not be the final disruption, there will be others and we shouldn’t just prepare for another pandemic, it might be different next time. However, ensuring the tools we select are agile, available online and resilient with rapid time to value will at least mean we are as well prepared as we can be for the future.

​To all my friends and colleagues in pharma manufacturing, good luck in your endeavours to keep the supply chain going. If you need help just ask!

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