Paper on glass, all you need in the palm of your hand

Transferring the paper-based processes in an electronic environment requires minimum changes. It has minimum impacts on the organization, people and procedures and no impact on equipment. The advantages are many:

• Avoided paper long-term storage
• Guided procedures reduce the possibility of human errors (missing entries or incorrect information)
• Compliance with Data Integrity policies
• Less data to review for the Batch analysis (Review by Exception)
• Reduction of batch release times
• Digital storage of data for controlling and improving the process
• Automated processing of data for Deviations, Variations, Violations, Warnings, Alarms, Audit trails

A fully automated and integrated solution

Compared to the traditional manual paper data entry methods, a user-friendly and portable interface represents a big advantage for the operator. The integrated paperless solution allows to:

• Drive the operator through the production sequence and to record critical processes
• Create a base to prove that each batch is fully compliant with internal procedures
• Use a configurable workflow that gives consistent sequence in production, with clear instructions and safety information
• Allow recording information from the operator’s hands, directly into the system
• Eliminate the risk of incorrect or missing entries
• Make batch recording and analysis documentation instantly available

Features and compliance

The system is specifically designed for the pharmaceutical market, and it is compliant with the industry regulations, with user access regulated by FDA 21 CFR part 11 and annex 11. All events are registered by the software in an audit trail file to keep track of all the security-relevant activities.

The continuous Software development follows Gamp 5, to always improve products quality and consistency.