Sterisart®️ Universal Pump | Gen 4 - 21 CFR Part 11 Compliance

Overview

Sterility testing in the pharmaceutical industry is a crucial regulatory requirement for final product release. It ensures that sterile pharmaceuticals and medical devices are free from viable contaminating microorganisms, confirming that each manufactured batch is safe for release.

Compliance with 21 CFR Part 11 is crucial for sterility testing in the pharmaceutical industry because it guarantees the integrity and security of electronic data, ensures accurate record-keeping, and facilitates regulatory audits. Adhering to these standards helps maintain the quality and safety of sterile products, protecting public health and meeting stringent regulatory requirements.

In this video, we guide you through enabling all software features necessary for achieving 21 CFR Part 11 compliance.


  • Document type: Video
  • Watch time: 11:02


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Key Takeaways

  • Sterility testing workflow and compliance with 21 CFR part 11

  • Visual step-by-step guidance for:

    • Role-based access & management

    • Audit Trail and electronic Records

    • Electronic Signatures

    • Record Protection & data integrity

    • Automatic Backup & Export & Timer controlled actions

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

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