Data Integrity and CFR Part 11 Compliance
All data generated by the Cubis® II balance follow 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 11 and EU Annex 11 compliance.
The Cubis® II balance, with 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.
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.
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.
The Cubis® II balance supports automatic time synchronization via Network Time Protocol (NTP). An accurate time stamp is elemental for trustable records.
Audit Trail & Alibi Memory
The Cubis® II balance’s audit trail is a tamper-protected time-stamped electronic log file, 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.
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 in other systems. Archiving is easily possible and fully compliant.
Save 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.
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.