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
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