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Automation: What RegulatoryTeam Needs to Know Before Investing
In recent years, Automaton has become more powerful and its applications to business have increased dramatically. As a result, companies and business functions, including Regulatory, that hadn’t seriously considered using Automation, are taking a fresh look. The appeal is obvious: different forms of automation can enhance performance and save costs while increasing the capacity of existing teams / investments.
Where Regulatory Organizations often struggle is in knowing where to invest in an Automation project that will really pay off. But if Automation hasn’t been a part of your company before, it can be hard to know where the real potential and risks lie.
If you are thinking about adopting, you should consider how it might create value, what good first projects might be, what tools/vendors to partner with, and whether you have the right talent on staff for your efforts to succeed in the long run. A first Automation project can be daunting, but knowing which factors to focus on will bring the project down to earth and clarify whether it’s worth the investment at all.
Will Automation create value for you?
“Why do we think this investment will be worth it?” is one of the first questions you’ll need to answer. That means knowing which source of operational pain (e.g., redundancy in particular tasks or freeing up teams time or bottlenecks in operational flow) you’re trying to address or where you’re aiming to improve efficiency. Automation projects should address processes that significantly impact cost or resource allocations, where the ultimate result can be a noteworthy impact to the bottom line.
Good candidates for Automation to provide value include:
- Activities that are very time consuming and labor intensive (e.g., Authoring, documents QC of documents/dossiers, Formatting, Submission readiness, and Reviews)
- Work flow activities that require data verification across systems (and sometimes verifying from documents)
- Regulatory impact assessments & change control (considering high volume requests coming in both from internal sources and external agencies)
- Processes that can be augmented with document/data analysis
- Data extraction from documents like CMC, Labeling
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