Data integrity within mission critical industries is extremely important, as correctly recorded information is the basis for ensuring product identity, strength, completeness and security. From Remorides R&D comes the Opera platform validated according to Cfr 21 Part 11 – GAMP 5 to help manage and optimise operational processes, support production lifecycle phases but also critical GxP data, in compliance with applicable regulations and Data Integrity.

Validated according to Cfr 21 Part 11 - GAMP 5

Opera Industry

The solution that connects to ALL Enterprise tools that historizes and organises data and processes that require Data Integrity compliance

Gestione paperless di processi (sia automatici che manuali mediante dispositivi mobili) in ambiti GxP
Gestione utenti e dispositivi aziendali/personali integrata
Reportistica automatica, Non Conformità, Audit Trail integrato
Connessione con tutti i dispositivi di produzione o di laboratorio mediante protocolli nativi o API standard
Integrazione con software di gestione aziendali (ERP, MES, ..)
Record Elettronici con Metadati in ogni processo
Report di Validazione di TUTTA la Soluzione

Ensure data integrity compliance through a digital quality
management system

OPERA Data Integrity allows to collect, store and organise data and processes that require Data Integrity compliance.

Opera is validated according to Cfr 21 Part 11 – GAMP 5 so all data is traceable and protected, and can be easily retrieved at any time. It is also a platform that can connect to all corporate tools and manage them in Data Integrity.

Some of the main features are:

Integrated management of users and corporate/personal devices

Paperless management of processes in GxP environments

Automated reports, Audit Trail and management of production or laboratory non-conformities via native protocols or standard APIs

Integration with enterprise management software (ERP, MES, …)

The creation of Electronic Records with Metadata in each process

 

With Opera Industry, processes comply with regulatory requirements (CFR 21 Part 11, EN 13485 MHR..)
and fulfil with ALCOA criteria.