The cost of complexity: why mid-tier manufacturers need to rethink regulatory technology strategy (part II)

Mid-tier manufacturers can avoid over-engineering by questioning scale, users and integrations, then prioritising built-in GMP workflows, integrated platforms and industry expertise, freeing budget to invest in future capabilities

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Part I showed how oversized or poorly matched QMS and RIM platforms inflate costs, slow implementation and divert investment from what matters; the next step is making sure your own procurement avoids the same fate.

Finding the right fit

The best place to start right-sizing your technology is also where most organisations should finish: with a hard look in the mirror before staring at vendor contracts.

The cost of complexity: why mid-tier manufacturers need to rethink regulatory technology strategy (part II)

Here are some questions we recommend every manufacturer consider before initiating the procurement process.

How big are we really? Not “one day” or “as we grow into next year’s budget.” How many batches are we running annually? How many sites do we operate?

How many submissions will we realistically process each year? Solutions tailored to a company’s current volume — with transparent scaling options should needs change — consistently outperform those designed for companies ten times their size.

How many users really need access? Unlike named-seat licensing models, concurrent licensing only charges for users who are actively using the system at any given time. 

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