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Roadmap For Covid-19 Management

How to Handle the Digital Push in Times of Crisis

Is your team alternating between home office and local premises – or is it already managing most of your production, quality and risk management activities from home? Either way, COVID-19 is putting companies’ digitalization to the test.

Those who had already turned themselves into digitalization champions in recent years may have had an easier time switching over to a remote-centered organization. No matter if the transition was easy or difficult – companies now need to take a closer look where room for improvement becomes visible through the remote way of working and where that potential may lie. Not only is that necessary for a successful restart, but also in order to prepare for a world in which global value chains have been disturbed. Annex 11 of the EudraLex states short and sweet, “provisions should be made to ensure continuity of support for those [critical] processes”. But: where to start when uncertainty becomes a constant factor? In our current projects we see the challenges but also our client’s progress, which can be summarized into three phases of “lessons learned” during the Corona crisis:

Phase 1: Address current pain points

First of all you need to tackle the challenges of today. The idea is to make quickly the right decisions when it comes to organization, communication and technology and concurrently to keep your business up and running. Particularly important in this case:

• Enjoy the firefighting: Keep an eye on all areas where work processes are struggling – until the problem has been solved. We also recommend keeping all business processes running in remote operation, not just core processes!
• Be smart: Potential flaws in workflows can be overcome often with simple technological solutions. For example, a mobile app that allows employees to quickly scan and securely send documents. In this case, the compliance owner should verify whether such applications are allowed, at least to secure a temporary workaround without putting data integrity at danger
• Be smarter: The transition to remote operations and teamwork via home office will reveal weak spots. Perhaps some of them were already known, but for those the company may have become blind to because “we have always done things that way” and “changing it would be too much work”. Going forward, an electronic document management or CAQ (computer-aided quality) system can help in areas where paperbased workflows are still being used that can no longer be dealt with by sending paper from office to office. It is important to make sure that new solutions are sustainable and based on the lessons learned from Corona, even after the crisis has passed.

Phase 2: Develop resilience for future crises

Companies that are successfully managing phase 1 can use their insights and best practice solutions in order to assess how beneficial those solutions will be during the next phase: Is the current solution helpful and/or valuable in other divisions? E.g. how can they contribute to a coordinated and more productive approach to document management or CAQ at the company in the future?

In contrast to previous crises or game-changing situations, we do not know how much time we have for this approach. The only thing that is certain is that COVID-19 is redefining the rules in the globalization game. Consequently, a variety of different scenarios should be considered for planning where at least one of them is based on alternating periods of a lockdown and relaxation thereof. With this kind of “drill” using different scenarios, it is important to reassess as many different stations of the value chain as possible to identify digitalization potential, especially in regard to the following aspects:

• Be ready to switch: How will the “stop & go” from normal to remote operation and back to normal affect business? Are the planning and validation processes used in compliance management prepared to handle these changes?
• Switch fast: Which technologies and organizational structures can be used to simplify and accelerate these transitions? Either way it is important to take a deeper look at the potential to digitalize former analog processes using document management or other software solutions.
• Switch safe: What is crucial for the success of remote (quality) operations? As a qualified person - Do I have all the information readily available and can probably prepare my manufacturing sign-off from home (following data integrity best principles)? It can help to know the opinion in regard of this topic of your local inspector. After all, not all measures are technical measures by a long shot.

Phase 3: Expand horizons

The third phase is to transition the organization to digital business processes, e.g., by successively increasing the number of digital services in production or for customers and partners. During this phase, drug manufacturers must also review and modify their supply chain strategy as well as a result of their supply warranties to customers/patients. Within that context, they should run through the different options of Europeanization: would it be worthwhile to re-establish regional delivery chains in case there are recurring pandemics or shutdowns?

There already seems to be a trend in that direction nowadays. In addition, production is benefiting from automation and even robotics, since even highly automated production systems in Germany still have room for development. The long-term idea here is to harmonize automation and digitalization so that processes always run smoothly in times of crisis. I am certain that the improvements you make as a result will not just have a positive impact on your company in times of crisis, but in general as well.