Pharma-Compatible Design: CUBIS® II

The CUBIS® II balance is designed as a modular system tailored to the user's needs. Users can choose from thousands of different configurations and numerous software and hardware options. With 45 different weighing modules, seven different weighing cabinets, 2 control units and 5 software packages, users can select from more than 60 weighing applications as required. This new CUBIS® II balance meets all pharmaceutical industry requirements with its MCA 7-inch display and QApp pharmaceutical software package that fully complies with pharmaceutical weighing requirements. This pharmaceutical software package is state-of-the-art for the pharmaceutical industry with data integrity, data processing and connectivity features. These include: • Advanced user management capabilities. • Full traceability with advanced Audit Trail features. • Automatic backup or archiving features to ensure data security. • Electronic signature. Data generated by CUBIS® II is created according to electronic records and data integrity standards established by ALCOA (+) for correct and secure output. The CUBIS® II pharmaceutical package includes all technical controls ensuring compliance with FDA 21 CFR Part 11 and EU Annex 11.

User Management

The CUBIS® II balance offers 2 options for complete user management by providing access control. Local user management can be configured to suit your password management. User management includes defined or non-editable roles (administrator, operator). However, it allows for configuration of these roles and assignment of individual roles. Passwords can be configured according to your company's encryption policy. For example, password length, whether the password contains letters or numbers, or validity period. Additionally, user management can be configured to change the password you have used. Also, automatic password inactivity after a certain period and maximum incorrect entry time can be configured. With active management, operational efficiency can be increased through the use of appropriate encryption rules. The CUBIS® II system can be integrated with the company's domain, allowing the use of SSO (single sign-on). Therefore, globally created encryption rules can be applied automatically. Groups can be defined and protected centrally. Thus, the entire user management process can be integrated into the company. User evaluation can be easily performed by the IT department without direct connection to the balance and without adding or removing users previously added to the process.

Electronic Signature

Electronic signatures are expected to have the same effect as handwritten signatures. In the CUBIS® II balance, electronic signature can be used to sign the final report for the weighing process based on user name and encryption. If your company policy treats electronic signatures and handwritten signatures equally, you can create and integrate a paperless weighing protocol.

Audit Trail

Audit trail is an electronic data file generated on a computer, protected against changes, allowing deletion, modification or creation of records and designated by time. In industries such as pharmaceuticals, the configured system must be delivered in an easily understood and readable format. In the pharmaceutical software package, audit trail data can be filtered by category and transferred elsewhere. Additionally, the CUBIS® II balance contains alibi memory that can automatically store weighing results to contain 150,000 data sets. These records cannot be deleted or modified; however, you can access them via web browser and use them for further analysis.

Reporting Function

Additional metadata must be added to create a pharmaceutical-compliant weighing protocol. Data such as example date and time, software version, balance ID, batch number etc. can be configured to contain the metadata required for secure recording. As a result, all data will be GxP-compliant. In the output, these values can be exported as electronically signed PDF or obtained in print form. In case of error, the user can provide the necessary explanation and cross out the incorrect data to mark it as invalid. This data is not deleted or hidden. However, it is displayed crossed out along with the valid data. The CUBIS® II balance can automatically create backups. These backups include audit trail data, outputs, log files, alibi memory and configurations. All GxP-compliant records are stored securely and can be archived by the IT department. All data is in a readable format without requiring special software.

Electronic Records

Electronic records must be protected against any manipulation. The CUBIS® II system allows MD5 to determine whether there has been manipulation in all files. The MD5 algorithm is used in finding digital fingerprints. IT systems such as LIMS can verify documents and compare them with the original checksum of CUBIS® II. If the result is the same, this indicates that no manipulation has been performed on these files. Connections The CUBIS® II balance provides almost all configurable connections. Hardware such as barcode scanners, printers or storage devices can be connected to the balance via Ethernet, USB-A, -B, -C and RS232. Connection devices can be used for data transfer to file servers via Windows file server (SMB) or secure file transfer protocol (FTPS). As a result, CUBIS® II balances are fully compliant with data integrity from start to finish. Moreover, it also includes many features such as different sample holders, automatic water balance, integrated ionizer and electrostatic discharge eliminator. The balance also contains information such as environmental conditions, warnings or errors. All hardware is developed to increase weighing efficiency and obtain error-free results. The pharmaceutical-compliant CUBIS® II QApp pharmaceutical package has been developed in full compliance with GAMP 5 and 21 CFR Part 11 requirements. Mustafa Yetim Sales Manager Sartonet Separation Technologies A.Ş.