Tag Archive | Automation

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.


Problems with Automation without feedback

It was a gloomy, soggy and chilly day. I went down to our pantry to get some coffee…My office is right next to the famed “Durham Bulls Athletic Park”. I was looking out the window and found the green grass on the outfield particularly green and shiny.

Then I noticed, despite the rain, the sprinklers were ON. I heard on the news that we are short of rainfall for the month, which means, come summer, restricted watering of lawns.

Anyway, the picture triggered off another thought i.e. Advantages & Disadvantages of Automation. The incident I just explained is a perfect example. By automating the watering of the outfield, the park maintenance team has done a good job of not only reducing the effort required but also ensured that it is done on a timely manner. However, what they forgot is to include a “Feedback” mechanism. This can be either automated or manually provided so that the sprinkler system is shutdown during the rains. If they have not built an automated feedback mechanism, then they should think of one. This could be either through a local news channel or national weather service, whatever is the easier way. Alternatively they can have personnel to check on the sprinkler system during the rains.

We can extend this analogy to organizations. This can be in terms of mission critical systems that are automated or even personnel related operations like “Annual Appraisals”. I have seen and experienced many organizations going through a very elaborate process to design and build a smart system or process. However, when it comes to obtaining feedback and improvising the system or process, they utterly fail. This could be either lack of a mechanism to collate and analyze feedback or gross negligence.

Moral of the story is, however smart the systems or processes are, unless until you build a good feedback mechanism to continuously improve, the systems will fail or will become outdated and costly over a period of time.

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