Pre-commercial biotech · Cambridge, UK
Vivien validated their first commercial system in 5 weeks
5 weeks
Time
−74%
Cost
0 days
Launch slip
The challenge
Small QA team validating the SAP S/4HANA upgrade required for commercial launch. Initial estimate from a Big-Four consultancy was 16 weeks and £640K.
The approach
Vivien Biotech ran a focused 4-week proof-of-value with cGen, starting from the GxP application inventory. By the end of week two, every system in scope was registered, categorised under GAMP 5, and assigned an owner. The validation projects that were in flight were migrated into the platform during week three. By week four, the team was running the new Inspector Mode against a simulated FDA scenario.
The outcome
Validation completed in 5 weeks at one-quarter of the consultancy estimate using cGen + a single contract validation engineer. Commercial launch hit on schedule.
"Without cGen we would have either missed our launch date or spent half a million pounds we did not have. We did neither."
What's next
Vivien Biotech is rolling cGen out across two additional sites in the next two quarters, and is one of the early-access programme's reference customers for the cGen three-stage rollout.
Could this be your story?
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