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Strengthen Lab Compliance—Start with Data Integrity at the Source
In today’s regulated lab environments, data integrity is critical—not just for compliance, but for trust and efficiency. This white paper from Sartorius outlines how laboratories can meet the stringent requirements of FDA 21 CFR Part 11 and EU Annex 11 by embedding data integrity at the instrument level. Using the Cubis® II balance as a benchmark, the guide introduces a practical, checklist-driven approach to evaluate compliance, focusing on built-in features like secure access controls, electronic signatures, audit trails, and seamless system integration.
Often underestimated in digital compliance, lab balances are actually central to generating audit-ready, traceable data. With native support for ALCOA+ principles, Cubis® II enables complete, accurate, and tamper-proof data handling—minimizing manual errors and ensuring end-to-end traceability across systems like LIMS and ELNs. Whether you’re adopting digital workflows or enhancing compliance, this guide gives you a solid foundation to assess your instruments and safeguard data integrity across your lab.
Key Takeaways
- Ensure full compliance with 21 CFR Part 11 using built-in audit trails, user roles, and secure e-signatures.
- Protect data integrity with time-stamped records, metadata, and tamper-evident storage.
- Prevent access violations through personalized login, password rules, and traceable user actions.
- Enable automated backups, secure data transfers, and easy archiving across your IT infrastructure.
- Eliminate manual errors and transcription risks by integrating directly with LIMS and ELNs.
- Use Cubis® II as a model for instrument-level compliance, built with ALCOA+ principles at its core.
