T&T Enterprise Serialization Software
AMACENA is an enterprise level, integrated, comprehensive soft¬ware suite to manage serialization / Track & Trace data from the production lines up to corporate level where interfaces allow data exchange with governmental servers.
The software is designed to fulfil highest quality standards as mandated by law in the phar¬maceutical industry. AMACENA is fully validated according to US regulation CFR21 Part 11 and GAMP5. Customers around the globe use the software, achieving highest OEE values at lowest reject rates. The use of AMACENA can be offered on subscription base as cloud service or as on-premise client-server solution.
AMACENA combines all ISA-95 levels from Level 1 to 4 into a single system. By doing so, no interfaces between the ISA-levels are re¬quired and only one data repository ensures a single source of truth.
The software is designed to fulfil highest quality standards as mandated by law in the phar¬maceutical industry. AMACENA is fully validated according to US regulation CFR21 Part 11 and GAMP5. Customers around the globe use the software, achieving highest OEE values at lowest reject rates. The use of AMACENA can be offered on subscription base as cloud service or as on-premise client-server solution.
AMACENA combines all ISA-95 levels from Level 1 to 4 into a single system. By doing so, no interfaces between the ISA-levels are re¬quired and only one data repository ensures a single source of truth.
The unique selling propositions of AMACENA
- One single Master Data Management repository for product and county specific data is fully compliant to GMP regula¬tions regarding data change (4 eye principle) and eliminate the manual data synchronisation between several linked systems and its manual documentation.
- AMACENA is fully validated and all software updates for the Cloud version are free of charge.
- Central creation and management of all print and camera artworks across all machines and logistics printers in the web-based Label Creator (see next page).
- AMACENA features a easy structure and uniform user inter¬faces for convenient operation.