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New Cubis® II Balances Paperlessly Support Requirements of CFR Part 11 and EU Annex 11


Sartorius have launched the Cubis® II portfolio of balances for R&D and analytical laboratories.

  • Fully customizable enabling thousands of configurations optimized for the user’s workflow
  • Supports 21 CFR part 11 and EU Annex 11 compliance with complete traceability
  • Easy, seamless integration with existing lab software and LIMS

The balances offer best-in-class performance including high capacity, excellent readability and robust stability and accuracy for all sample types. Configurable hardware and software are fully customizable to maximize operational efficiency and experimental outcomes. The Cubis® II portfolio offers modern user interfaces, pharmaceutical and GxP compliance including data handling, data integrity and connectivity, ergonomic sample handling, easy process integration and unlimited communication at the highest level of accuracy and precision.

The balances were designed for intuitive operation, which is further aided by intelligent diagnostic systems. This guarantees a higher degree of repeatability of workflows, while lowering the possibility of human error during the measurement steps. Standard operating procedures can be configured as an approved workflow.

“Building upon the success of our Cubis® line of laboratory balances, the Cubis® II portfolio delivers exceptional performance and unmatched flexibility to meet the diverse needs of users in regulated environments,” said Gerry Mackay, member of the executive board, Sartorius Lab Products and Services division. “The Cubis® II integrates seamlessly into existing workflows unlike universal balances which may require a lab’s standard operating procedures to be adapted to the functionality of the balance.”

Key features and benefits of the Cubis® II portfolio include:
Customized Modularity
A modular design and broad selection of capacity and readability options, draft shield types, weighing pans and displays enables 6,000 possible hardware configurations for optimized workflows. The initial hardware configuration can be enhanced over time with additional accessories. New software applications will be available ensuring long-term flexibility and adaptation to the evolving needs of the laboratory.

Powerful, Adaptable and Future Proof Software
QApp software is adaptable to specific user requirements. A unique onboard QApp Center allows direct download of protocols and creation of customized applications to meet the needs of individual labs and users. Customers opting for a QApp package will receive all updates and new applications for that package, ensuring a future proof solution.

Seamless Connectivity
Cubis® II balances are easily integrated with laboratory software and LIMS systems, eliminating the need for separate software islands. LIMS/data collection software connectivity ensures data accuracy and readiness for regulatory agency submission.

Confident Compliance
Cubis® II balances fulfill all requirements for use in fully compliant processes for regulated markets such as pharmaceutical and biotechnology and applied markets including environmental, food and beverage, medical, chemical and automotive.

The Cubis® II is the first balance to support all the requirements to achieve CFR part 11 and EU annex 11 compliance in a paperless manner, eliminating the possibility of process data or signature falsification. The balances ensure an authenticated electronic record from data acquisition to analysis. Control over user access levels and protocols, including the ability to pull logins directly from the user’s LIMS system, ensures traceability and limits potential errors.

 

 


    

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Date Published: 19th March 2019

Source article link: Sartorius AG


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