Medical, Pharma and Biotech industry

Digitised processes in compliance with Data Integrity

Data are an essential part of any life science process and a major concern for regulatory compliance. A key aspect of ensuring the quality of the final product and compliance with standards is to ensure the accuracy and consistency of the data, from the point where it is generated to its storage, keeping track of all actions performed and instrumental measurements made. With the Opera platform you can achieve:

  • connection with all production or laboratory devices via native protocols or standard APIs;
  • integration with enterprise management software (ERP, MES, DHF, IPC, DMR..);
  • uniquely identified electronic records with Raw Data and Metadata.

Our platform is validated according to GAMP 5 and meets the requirements of Cfr 21 Part 11. Due to its open and scalable architecture, it is able to connect to all instruments, machines and test benches ensuring compliance and increasing operational efficiency.


  • Centralized management of machines and systems in data integrity
  • Complete digitization of both automated and manual processes
  • Compliance with GxP regulatory guidance
  • Full compliance with ALCOA criteria
  • Automated reports, management of Nonconformities and complete Audit Log

Case Studies