Cubis® II MCA 21 CFR Part 11 Compliance Checklist | eBook
Overview
The Cubis®️ II balance, with pharma package, contains all the technical controls to support compliance with common regulations. Full compliance can be achieved with additional procedural controls and systems for long-term data storage. This checklists helps you to keep an eye on relevant details of the regulation. In addition you can see how Cubis®️ II is offering solutions to be fully pharma compliant.
Document type: ebook
Page count: 10
Read time: 22 minutes
Author: Sartorius
Key Takeaways
- Detailed insights into FDA’s 21 CFR Part 11 standards for electronic records and electronic signatures
- Practical guidelines for setting up systems that meet regulatory requirements
- Knowledge about the Cubis® II MCA system’s capabilities
- Importance of validating laboratory systems and maintaining documentation for regulatory compliance audits
Audience
- Lab Managers and Directors
- Lab Assistants
- Quality Control Experts
- Compliance Officers
- Pharmaceutical Industry
- Biotechnology Industry
Applications Covered
- Compliance with 21 CFR Part 11
- Data Integrity Management
- Audit Trail
- Cubis® II MCA
