It seems to be a common experience. You have identified a situation to be remedied, you just started a change, or you are right in the middle of it. You notice something is missing: someone to focus on what is ahead to take it through, a sparring partner to vet ideas, a subject matter expert, you name it…
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Evolving regulations, mergers, changing business, international harmonization and other factors may require you to optimize your process landscape. Make this an opportunity to leverage synergies, simplify, and increase the robustness of your process framework.
Ensure that your systems support your processes and that your systems interact flawlessly. Also ensure that your system landscape is easily maintanable and that you have adequate control, even if you subscribe to service models.
Data is your most valuable asset. Just as your processes and systems need care, so does your data. Data entry conventions change over time and that may have deep impacts on the reportability of your data. Regularly revise key data to minimize the “garbage in – garbage out” effect. Just as software vendors refactor their code, maintain your data. Make review and cleansing part of any data migration effort.
For computerized systems, validation is not just software verification, it also looks at whether the design of all components (including infrastucture and interfaces) is adequate, it ensures relevant documentation, also of guiding processes, and it ensures sufficient training of the stakeholders, not just the primary users.
AI is becoming ubiquitous, but 2 points must always be considered: