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Cubis® II Pharma Compliant by Design

Cubis® II Pharma Compliant by Design
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Cubis® II Pharma Compliant by Design - 1

White Paper March 6, 2019 Keywords or phrases: Lab Balances, 21 CFR Part 11 Compliance, Pharma Compliant, Audit Trail & Alibi Memory, Backup, Safe Data Transfer, User Management, E-Signatures, Time Synchronization Cubis II Pharma Compliant by Design ® Dr. Georg Schwarz gempex GmbH, Besselstrasse 6, 68219 Mannheim, Germany 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 (Figure 1). QApp Pharma Package Fully Compliant Figure 1 Find out more: www.sartorius.

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Cubis® II Pharma Compliant by Design - 2

User Management 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...

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Electronic Signatures Report Functionality Electronic signatures are expected to have the same impact as hand-written signatures, so that, based on a secure password, the combination of username and password is accepted in all regulatory instances. In the Cubis® II environment, an electronic signature (ES), based on a secured user name and password, can be used to sign the final report for a weighing process. If your company policy equates the ES and a handwritten signature, a paperless weighing protocol can be produced and integrated, for instance, in the entire batch protocol review...

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Time Synchronization An accurate time, traceable to UTC, is necessary for trustworthy records. Therefore, the Cubis® II balance supports automatic time synchronization via Network Time Protocol (NTP). In most companies, time servers are available and can be provided by the customer’s IT department. If a time server is unavailable, a standard time server service can be implemented. All changes to the configuration of the time synchronization are restricted to authorized persons and logged in the audit trail. The Cubis® II balance provides nearly all common configurable interfaces through its...

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Tasks, Profiles & Connectors Save Weighing Protocols A weighing process is built by the combination of tasks and profiles. Standardize your work by configuring tasks to carry out a certain protocol. For instance, a task can be linked to two different print profiles, so executing this task exports a PDF to a file server for data archiving and also prints out the weighing protocol to a default printer (Figure 6). For the execution of weighing tasks, the internal balance adjustment can be set to mandatory to avoid recording weight without proper adjustment of the balance. The result of the...

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Cubis® II Pharma Compliant by Design - 6

Sales and Service Contacts For further contacts, visit www.sartorius.com Germany Sartorius Lab Instruments GmbH & Co. KG Otto-Brenner-Strasse 20 37079 Goettingen Phone +49 551 308 0 Specifications subject to change without notice. Copyright Sartorius Lab Instruments GmbH & Co. KG. All Rights Reserved. Printed in the EU or US on paper bleached without chlorine. Version 2020 | 04

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Cubis® II Pharma Compliant by Design
6Pages