Sartorius Cubis II Precision MCE Balances are a completely configurable, high-performance portfolio of both labs weighing hardware and software. The Cubis II will align with your unique demands and compliance requirements to help maximize your operational efficiency and experimental outcomes. The MCE Essential User Interface is a large, high-contrast touch display with factory-installed essential weighing applications for easy operation.
Avoid the burdensome process of preparing the balance for use with the Cubis II balance’s quick and easy, motorized, auto-leveling function. The gesture sensor recognizes four gestures and can be positioned near the balance, directly in the flow of motion at the workspace. It allows the user to open and close the automatic draft shield, start the ionizer, or send a document to the device (check your balances specifications for specific options included). The built-in ionizers remove balance stabilization frustrations caused by electrostatic effects. Electrostatic charges on samples and vessels are removed effectively, just by pressing one key or automatically when the draft shield door closes.
A climate sensor monitors influencing variable of the environment and ensures that temperature, pressure, and humidity do not negatively affect the results.
Complete Traceability: Back-Up and Data Transfer
All data generated by the Cubis II balance follows the key principles ALCOA (+), which defines data integrity standards and relates to GxPs. Therefore, the Cubis II balance ensures safe and accurate data storage and supports all requirements for FDA directive 21 CFR Part II and EU annex 11 Compliance.
Cubis II can automatically execute time-controlled actions for backup. The system is able to upload data on a file share or export the data to other systems. Archiving is easily possible and fully compliant. An electronic record should be protected against any manipulation. The Cubis II balances saves all files, together with a calculated MD5 check-sum which is stored in the audit trail files and additionally in a separate MD5 file.
Audit Trail, Alibi Memory & Time Synchronization,
The Cubis II balance’s audit trail is tamper-protected time-stamped electronic logfile, that allows reconstruction of events related to the creation, modification, and/or deletion of records. The data can be displayed, filtered, and exported in an easy way.
Additionally, the Cubis II balance contains an “Alibi Memory”. The system automatically stores weighing data in a ring buffer.
The Cubis II balance supports automatic time synchronization via Network Time Protocol (NTP). An accurate time stamp is elemental for trustable records
User Management & Electronic Signatures
The Cubis II balance provides two options for complete user management with access control. The local user management can be configured in accordance with the user’s password policy. The password rules for 21 CFR Part 11 compliance are easily implemented. Moreover, Cubis II can be integrated in the company’s domain to allow single sign-on. Int his case, the company defined password rules are implemented automatically.
In the balances, an electronic signature can be used to sign the final report for weighing processes. Based on a secure password, the combination of username and password is fully compliant with 21CFR.
Thousands of hardware and software configurations supporting personal preference
Seamless connectivity to diverse laboratory information systems without the need of additional software
Long-term flexibility guarantees adaptation of software and accessories to evolving regulatory and laboratory needs
Built-in applications guide the user through their workflow
Fast and easy leveling guaranteed with automatic, motorized leveling function
Innovative draft shield technology with gesture sensor and memory functions
Climate sensor for environmental monitoring
Built-in ionizer for automatic electrostatic elimination
Full data integrity following ACOLA+ principles
Complete traceability via advanced audit trail and reporting function for efficient reviews
Submission-ready data with remote data selection on web browser
User management including centralized password management support (?single-sign-on” via LDAP), high security password
Electronic signature in compliance with 21 CFR Part 11