Cubis® II Balances, Your Ally for Audit Preparedness | eBook
Author: Sartorius | Last updated: Nov 2024
Overview
Many analytical techniques involve weighing steps, where errors can occur. These mistakes can have significant and cumulative effects, potentially leading to invalidation of release tests, cross-contamination, or high analytical uncertainties. Recognizing the importance of accurate weighing, pharmacopoeias provide guidance on planning, verification, and protocol.
Cubis® II balances are designed to meet high regulatory standards:
This guide helps you understand how the Cubis® II balances secure your daily weighing reliability and back you up for internal or external audits.
- Materials are built to withstand cleaning agents and facilitate easy disassembly & assembly
- Direct connectivity & secure data integrity by software features adhering to ALCOA principles, 21 CFR Part 11, and EU Annex 11 guidelines.
- Pre-installed apps guide operators through weighing processes minimizing human error.
- Versatile sample holders simplify weighing into various containers/vessels
- Automatic internal adjustment and built-in compensation methods reduce the effect of external environmental influences.
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- Document type: eBook
- Page count: 20
- Read time: 15 minutes
Key Takeaways
- An understanding of how advanced features like internal/external calibration, pre-installed apps, and secure data management improve laboratory workflows
- Steps to ensure weighing processes meet audit requirements, including data traceability and compliance with USP <1251>, 21 CFR Part 11, and EU Annex 11
- Practical examples of using Cubis® II balances for diverse tasks like calibration, minimum weight monitoring, and working with challenging materials or environments
This Resource is Designed for:
- Scientists
- Lab Directors and Lab Managers
- Lab Technicians and Lab Assistants
- Lab Balance Users
- Compliance Experts
Applications Supported:
- Lab Weighing
- Analytical Balances
- Cubis® II Balances
- 21 CFR Part 11
- Compliance
- Air Buoyancy Correction
- Calibration
