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Automation in Regulatory Affairs : 5 essential criteria for process selection

In the last month at least 3 clients (top 10 Pharma) that I spoke to brought up Automation in the context of Regulatory Affairs. While it is very common for everyone to get excited about some of the popular technology trends and jump on the bandwagon to adopt these within a business context, many such initiatives fail to find traction and success unless they are carefully managed with a strategy and plan.

Regulatory Affairs function is not immune to this temptation. However, the excitement is typically tampered by the implications of things not working out resulting in regulatory compliance issues and product approvals. However, many activities within Regulatory Operations are repetitive in nature and are very conducive to being considered for automation. In my opinion, the criteria that should be considered while assessing a business process for automation are:

  1. Process Type: Nature of the Business Process in terms of Strategic vs. Tactical
  2. Frequency: How frequently is the process invoked to deliver business value
  3. Manual Tasks: How many tasks within a process are manual in nature and are leading to process inefficiencies and errors
  4. Benefit: How much hard/soft benefit can be delivered by automating the tasks
  5. Performance: Can the steps be measured easily to assess the performance

Assessment & Prioritization:

To create a strategic plan for automation, each process in Regulatory Affairs ranging from Regulatory Strategy to Life Cycle Maintenance can be assessed based on these criteria. RA-Automation-Criteria

Prioritization of the processes and/or tasks within a process can be done by arriving at a balanced scorecard for automation. The weightages provided in the chart can be used as reference but can always be tailored based on any given organizations’ needs and inputs. The criteria can also be leveraged at the enterprise level to assess other functional areas like Clinical and Safety, in order to prioritize at the department level to assign and approve budgets. The key is a structured way of identifying opportunities, assessing them for automation ability and prioritizing based on balanced scorecard. RA-Balanced-Scorecard

The above score card does not cover all the processes of the Regulatory Affairs processes. However, it is used to illustrate how to create a balanced score card to prioritize the processes for automation.

While organizations are considering moving to a Regulatory Information Management platform of the future, they can still consider automation as a way to compliment process improvements achieved. In fact, I strongly recommend creating an ‘Automation’ workstream as part of the RIM initiative so that all the work done to harmonize the processes and transform the processes in preparation for new platform adoption can be harnessed to assess and prioritize the processes for automation with minimal impact to ongoing work.

In a subsequent post, I will look at the processes within Regulatory Affairs that can be prioritized over others, based on my experience. I will also look at potential use cases within each process.

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