Sterisart® Universal Pump | Gen 4 - 21 CFR Part 11 Compliance Checklist White Paper | Sartorius
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White Paper: Sterisart® Universal Pump | Gen 4 - 21 CFR Part 11 Compliance Checklist

Last updated: March 2024

Overview

Discover how the Sterisart® Universal | Gen 4 ensures your pharmaceutical processes meet the stringent requirements of 21 CFR Part 11. This white paper provides an in-depth look at the importance of electronic records and signatures compliance, offering a robust solution that safeguards patient safety, product quality, and regulatory adherence.


  • Document type: White Paper
  • Page count: 12
  • Read time: 10 minutes


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Key Features for 21 CFR Part 11 Compliance:

  • Integrated barcode scanner for seamless data capture
  • Pump, scan, record mode for efficient data reporting with electronic signatures
  • Ensured data integrity and traceability for peace of mind

Comprehensive Compliance Checklist:

  • Detailed guidance for both closed and open system controls
  • Best practices for managing electronic records and signatures
  • System access protocols to maintain security and integrity

Deep Dive into Regulations:

  • Thorough interpretation of 21 CFR Part 11 requirements
  • Insights into electronic signatures and controls
  • Actionable steps for customers to maintain regulatory compliance

This Resource is Designed for:

  • Microbiological Testing Lab Managers
  • Microbiology Managers for Pharma QC
  • Sterility Testing Operators
  • QC Analysts
  • Method Validation Experts

Applications Supported:

  • Sterility Testing
  • Pharmaceutical Applications
  • Microbiological Quality Control

Complete the Form to Access the White Paper