Protecting Data Integrity – Evaluating Instruments in the Lab
From audit trails to secure data transfer—compliance starts at the bench.
As laboratories digitalise operations, regulatory agencies are raising the bar on data integrity. Sartorius’ latest compliance guide offers a practical, instrument-level checklist aligned with FDA 21 CFR Part 11 and EU Annex 11. This white paper helps labs ensure their data-handling instruments—including balances—meet all technical control requirements, without relying solely on external middleware.
What you’ll learn:
- Why data integrity matters for accuracy, reproducibility, and regulatory approvals.
- How violations occur—with 79% of FDA 21 CFR Part 11 breaches tied to access control, audit trails, and data handling gaps.
- What compliance-ready instruments look like, using the Sartorius Cubis® II as a reference model.
- How native features such as electronic signatures, audit trail retention, user traceability, and encrypted backups simplify validation and streamline compliance.
- How to assess your instruments with a comprehensive CFR Part 11 checklist included in the guide.
Key compliance features covered:
- Secure user authentication and role-based access control
- Real-time audit trails and “Alibi” memory for raw data integrity
- Metadata-rich, timestamped data for full traceability
- Safe file transfer protocols (FTPS, SMB, USB, LDAP)
- Built-in backup scheduling and long-term archiving support
- Integration-ready with LIMS, ELN, and central IT systems
Digitally compliant. Lab proven. Ready for your next audit.
From fine chemicals to pharma QA/QC, Sartorius instruments like the Cubis® II help reduce compliance risk and improve process control. With this white paper and checklist, your lab can implement a top-down integrity strategy that leaves no device behind.
Download the white paper and start your data integrity assessment today.
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