How to Achieve Pharma Compliance with Lab Balances

Introduction

The Cubis^® II balance series was designed for customizable modularity, which means the user can choose from many hardware and software options for thousands of different configurations. Choose from among 45 weighing modules, seven draft shields, two display and control units, and five software packages, including more than 60 software Apps.

Meet the requirements of the pharmaceutical industry with a combination of the MCA high-end 7” display and specific QApp pharma package, providing all features needed for a full pharma-compliant lab balance system.

The configuration of this package is state-of-the art for the pharmaceutical industry, with a focus on optimal connectivity, data integrity, and data handling by design:

• Comprehensive User Management with an option for “Single Sign-on” centralized user management across the organization
• Full traceability with advanced Audit Trail and a reporting function for efficient reviews
• Requires less effort to go paperless with new print process and electronic signatures
• Automatic Backup/Archiving functionality to ensure data safety

Data generated by the Cubis^® II follow the key principles defining data integrity standards for accurate and reliable paper and electronic records as defined by ALCOA (+). Modern data handling enables safe storage in various ways.

The Cubis^® II with pharma package contains all the technical controls to support compliance with the FDA directive 21 CFR Part 11 and EU Annex 11. Full compliance can be achieved with additional procedural controls and systems for long-term data storage.

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