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OPUS-Validierung

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Product details

Management number 210900004 Release Date 2026/04/04 List Price $36.00 Model Number 210900004
Category

The OPUS VALIDATION PACKAGE caters to all requirements for operating FT-IR, NIR, and Raman spectrometers in accordance with current pharmaceutical regulations.

  • Automated Performance Testing Against Pharmacopeia Standards (e.g., USP, Ph. Eur.)
  • Qualified for cGMP Use
  • Electronic Records and Signatures Compliant with 21 CFR Part 11
  • Meets Latest FDA Data Integrity Guidelines
  • Advanced User Management Based on Role Separation (SOD) Concept
  • Comprehensive Audit Trails
  • System Validation Manual for Support and Documentation of Qualification Process
Color gray, black
Brand Name Bruker
Manufacturer Bruker

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