Confident 21 CFR Part 11 Compliance – Complete Traceability

Sartorius’s Cubis® II is the first balance that supports all requirements to achieve 21 CFR part 11 and EU Annex 11 compliance without needing a single sheet of paper and eliminating the possibility to falsify process data and/or signatures.

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Audit Trail & Alibi Memory

The Cubis® II balance’s audit trail is a 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.

Safe Data Transfer

An electronic record should be protected against any manipulation. The Cubis® II balance saves all files, together with a calculated MD5 checksum which is stored in the audit trail files and additionally in a separate MD5 file.

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User Management

The Cubis® II balance provides two options for complete user management with access control. The local user management can be configured in accordance with your 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. In this case the company defined password rules are implemented automatically.

Electronic Signatures

In the Cubis® II balance, 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.

White Paper

Advanced Compliance For Use in Regulated Sectors

Sartorius’s Cubis® II is designed to follow US FDA data integrity principles that require data to be accurate, legible, contemporaneous, original, and attributable (ALCOA).

The Cubis® II balance, with the Pharma package, contains all the technical controls to support compliance with common regulations. Full compliance can be achieved with additional procedural controls and systems for long-term data storage.

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