Atlas replaced 6 spreadsheets and a broken eQMS module — and landed a 90-minute FDA walk-in

The challenge

Six tracked spreadsheets, two ageing point tools, and a half-broken eQMS module. Every periodic review took 11 days. The QA team had to build the inventory by hand the week before any audit.

The approach

Atlas Therapeutics 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

Inspection-ready inventory built in 4 weeks. Last FDA walk-in lasted 90 minutes with zero observations. Periodic review time fell from 11 days to 2.

"We replaced six spreadsheets, two point tools, and a half-broken eQMS module with cGen. Our last FDA walk-in took 90 minutes because the inspector found exactly what they needed in Inspector Mode."

What's next

Atlas Therapeutics 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.