Injectables & Sterile
Parenterals, lyophilised products and ophthalmics
The most heavily scrutinised category. Environmental monitoring, media fill records and aseptic process simulation have to be part of the batch record, not a separate file the inspector asks for.
What this configuration adds
- Environmental monitoring bound to the batch, area and time window
- Media fill and aseptic process simulation records
- Sterilisation and depyrogenation cycle records with load patterns
- Lyophilisation cycle data captured against the batch
- Personnel gowning qualification enforced at the batch record
The same core underneath
Every industry configuration is the same fifteen modules, the same audit trail and the same validation approach. What changes is the masters, the batch record structure and the records that segment is inspected against.
That means you are not buying a bespoke system. You are buying a proven one with your segment's requirements already built into it — which is why a rollout takes months rather than years.
Core modules in this configuration
All fifteen are available. These are the ones a injectables & sterile operation usually starts with.
See it on your own floor.
Two hours with your production and QA leads. We walk one product end to end and show you where it lands in the system — then you decide whether a gap study is worth it.