Contract manufacturer · Frankfurt, DE
NovaCDMO migrated 240 validation records from a legacy platform in 11 days
11 days
Migration time
100%
Records preserved
14
Sponsor portals
The challenge
Multi-sponsor CDMO with 240 validation records spread across a legacy CSV platform whose vendor announced end-of-life. Each sponsor demanded their own inspection portal.
The approach
NovaCDMO 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
Full migration in 11 days using the cGen wizard. Each sponsor now has a dedicated Inspector Mode portal with their records only. Two sponsor audits passed in the first quarter post-migration.
"The wizard ran our staging migration on Friday. By Tuesday we were live, by Friday again we had passed our first sponsor audit on the new platform."
What's next
NovaCDMO 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?
Join the early signup queue and be first to access cGen when we launch.