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:
- Process Type: Nature of the Business Process in terms of Strategic vs. Tactical
- Frequency: How frequently is the process invoked to deliver business value
- Manual Tasks: How many tasks within a process are manual in nature and are leading to process inefficiencies and errors
- Benefit: How much hard/soft benefit can be delivered by automating the tasks
- 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.
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.
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.
Over the last 6 months I have spent a lot of time talking to various clients about transforming their Regulatory Affairs organization in terms of Processes, Data and Systems. Many organizations are looking for a holistic approach to transformation, across all the three aspects and additionally assure better user experience. The following are the themes that are emerging, with regards to challenges faced by Regulatory Affairs organizations:
- Functional, Geographical and Departmental silos creating hurdles for x-functional collaboration
- Fragmented systems and tools, a situation that is a result of efforts to build best-of-the-breed platforms combined with legacy systems that leave the burden of end-to-end integration to the pharma companies
- Need for continuous upgrade / enhancements of various tools to keep up with regulatory and technology changes which create a need for projects all the time disrupting business and IT teams
- Inefficient business processes and data governance that is either a result of trying to make up for lack of features in the chosen systems & tools or due to #1 above
- Finally, lack of human centered design of systems leading to lower of adoption, process inefficiencies, compliance issues etc.
In order to overcome these challenges, many organizations have prioritized programs to find a platform that can become their Regulatory Affairs Management platform of the future. Having spent time working with various pharma companies, tool vendors and industry experts in Regulatory Affairs, I have come to the conclusion that the following five platforms are leading the pack in terms of becoming the platform of choice for end-to-end Regulatory Information Management. Also, I know of at least one Top 20 Pharma, Biotech, Med Devices customer that has selected one of these platforms to invest in and make it their platform of the future.
- AMPLEXOR LS Suite
- ArisGlobal LifeSphere Regulatory
- OpenText Documentum D2 LS Suite
- PAREXEL Regulatory Cloud and
- Veeva Vault RIM
Some of the other notable names that are either being considered by smaller pharma, generics companies etc.:
- DXC Regulatory Suite
- Mission 3
If the challenges I have listed in this post resonate with you then I strongly recommend considering one of the top 5 platforms listed above as a means to address these challenges. While platform is not a silver bullet that can solve all the challenges listed, it is definitely a good starting point. Along with the platform, “Business Process Transformation” and “Innovation” should be high on the agenda to make a difference to your Regulatory Affairs staff and help them improve their cycle times and in turn faster approvals to your products. In a subsequent post, I will look at the criteria to be used in evaluating the right platform for your needs as well as elaborate on the need for Business Process Transformation and opportunities for innovation in Regulatory Affairs.