Cumartesi, Ekim 23, 2021

CUBIS® II: Pharma Compliant by Design

The CUBIS ® II balance is designed for customizable modularity. This means that users can choose from several software and hardware options with thousands of different configurations.

With 45 different weighing modules, seven draft shield, 2 control units and 5 software packages, users can choose from more than 60 software applications as desired.

This new CUBIS ® II balance meets all the requirements of the pharmaceutical industry with the MCA 7 inc display feature and the QApp pharmaceutical software package that provides all features needed for full pharma- compliant lab balances system.

The configuration of this package is state-of-the art for the pharmaceutical industry, with optimal connectivity, data integrity, and data handling:
• Advanced user management.
• Full traceability with advanced Audit Trail.
• Automatic Backup/Archiving functionality to ensure data safety.
• Electronic signatures.

Data generated by the CUBIS® II follow the key principles defining data integrity standards for accurate and reliable paper and electronic records as defined by ALCOA (+).

The CUBIS® II with pharma package contains all the technical controls to support compliance with the FDA directive 21 CFR Part 11 and EU Annex 11

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.

User management includes predefined, non-editable roles (e.g. Administrator, Operator), but allows addition of individual roles and configuration of role rights.

Passwords can be configured according to your company’s password policy, for instance, by defining password length,complexity, and validity period. In addition, user management allows configuration for exclusion of already used passwords.

Also, an auto logout after a specified period of inactivity, and the rules after maximum failed login attempts can be configured.

Increase operational efficiency through use of available password rules in the active directory. The CUBIS ® II system can be integrated into the company’s domain to allow use of SSO (single sign on). In this case, global defined password rules are implemented automatically.

Groups can be defined andmaintained centrally, so the whole user management process can be integrated into the company environment. User review can be easily performed by the IT department, without direct accessto the balance, and adding or removing a user will follow the already implemented processes.

Electronic Signatures

Electronic signatures are expected to have the same impact as hand-written signatures. In the CUBIS® II scale, the electronic signature can be used to sign the final report for the weighing process depending on the user name and encryption.

If your company policy equals the electronic signature and the handwritten signature, you can create and integrate a paperless weighing protocol.

Audit Trail

An audit trail is a computer-generated, tamper-protected, timestamped electronic data file that allows reconstruction of events related to the creation, modification, and/or deletion of records. The system configured in industries such as pharmaceuticals should be delivered in an easily understandable and readable format.

In the pharmaceutical software package, audit trail data can be filtered according to the category and transferred to another location.

Additionally, the CUBIS® II balance contains an alibi memory; the system automatically stores weighing data in a ring buffer that can hold up to 150,000 datasets. These records cannot be deleted or manipulated; however, the list is accessible via the web browser and can be used for additional analyses.

Report Functionality

To create a compliant weighing protocol, additional metadata must be added. Data, such as sample date and time, software version, balance ID, user ID, batch number, and so on, can beconfigured to include all required metadata for reliable records.

Finally, the whole data set can be included in a GxPcompliant weighing report. In the print process, such values are included in the report and can be printed or exported as an electronic, signed PDF.

In case of a mistake, a user is able to mark an incorrect dataset as invalid. This data is not deleted or hidden. But, it is displayed in a crossed-out text with valid data. The CUBIS® II balance can automatically backup.

This includes backup, audit trial data, printouts, log files, alibi memory, and configurations. All GxP compliant recordings are stored securely and can be archived by the IT department. All data are in a readable format without the need for specific software.

Electronic Records

Electronic records must be protected against any manipulation. The CUBIS® II system allows you to determine by MD5 whether all files are manipulated. The MD5 algorithm is used to find the digital fingerprint.

IT systems, such as LIMS, can provide documentation and compare with original checksum of CUBIS®II. If the result is the same, it means that no manipulation has been done on these files.

Interfaces

CUBIS ® II balance provides nearly all configurable interfaces. Hardware such as barcode scanner, printer or storage device can be connected to the balance via Ethernet, USB-A, -B, -C and RS232. Connectors can be used to transfer data to the file server via Windows file server (SMB) or secure file transfer protocol (FTPS).

As a result, CUBIS ® II balances are fully compatible with data integrity from start to finish. Furthermore, it includes a variety of features such as different sample holders, motorized automatic levelling, integrated ionizer and electrostatic charge eliminator.

The balance also contains information such as environmental conditions, warnings or errors. All of the equipment has been developed to increase the efficiency of the weighing and get accurate results.

The QApp pharma package was developed considering GAMP 5 guidance and fulfills all 21CFR Part 11 demands through an integrated audit trail.

 

Mustafa Yetim
Sales Responsible
Sartonet Seperasyon
Teknolojileri A.Ş.

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