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Cubis® II Pharma Compliant by Design

Cubis® II Pharma Compliant by Design

 

Cubis® II Pharma Compliant by Design

21 CFR Part 11. EU Annex 11. ALCOA+. Fully covered.

Sartorius’ Cubis® II balance series goes beyond precision—it’s engineered for compliance in regulated pharmaceutical environments. With the MCA high-end display and QApp pharma package, Cubis® II delivers all the technical controls needed for GxP operations, data integrity, and paperless workflows—right out of the box.

What makes it pharma-ready:

  • Integrated audit trail & alibi memory for tamper-proof, time-stamped logs of every action.
  • Electronic signatures (ES) compliant with FDA expectations, enabling paperless batch records.
  • Customisable user management including Single Sign-On (SSO) and Active Directory support.
  • Auto-backups & archiving of all audit trails, log files, and weighing reports as encrypted PDFs.
  • Real-time time synchronisation via NTP for UTC-traceable records.
  • MD5 checksums for tamper detection of digital files—ensuring trust in every exported record.

System advantages:

  • Easy connection to LIMS, printers, and file servers via Ethernet, USB-A/B/C, RS232, FTPS and SMB protocols.
  • Web-based access for audit review and remote configuration (see Figure 5, page 4).
  • Intelligent task workflows, automatic levelling, and error tracking for higher productivity (see Figure 6, page 5).
  • Complies with GAMP 5 and supports validation-ready implementation into GxP labs.

Digitally secure. Operationally efficient. Audit-ready by design.

With Cubis® II, Sartorius provides a scalable balance platform that ensures data integrity and regulatory compliance—whether for routine QA/QC or complex R&D environments. Simplify your compliance burden while improving lab performance.

Download the white paper to explore how Cubis® II safeguards your weighing process from bench to batch record.

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