Agilent Cary UV Workstation Software for Cary 3500 Compliance White Paper

About this manual

The document serves as a resource for users of the Agilent Cary UV Workstation with OpenLab software, specifically addressing requirements for regulated pharmaceutical organizations under US FDA Title 21 CFR Part 11 and Eudralex Chapter 4, Annex 11. It outlines how the software's technical controls assist in meeting these regulatory standards.

The paper covers three specific elements of a regulated laboratory's operation: security of electronic records, attribution of work, and electronic signatures. It distinguishes between technical controls provided by the software supplier and procedural controls that must be established by the user organization.

What's inside

• Overview
• 21 CFR Part 11 Requirements
• Security of Electronic Records
• Attribution of Work
• Electronic Signatures
• System Topologies
• Validation

Frequently asked questions

What are the three specific elements of a regulated laboratory's operation covered by 21 CFR Part 11?

The document states that 21 CFR Part 11 covers: Security of electronic records, Attribution of work, and Electronic signatures (if used).

Who is responsible for establishing procedural controls such as standard operating procedures?

The user organization and their staff are responsible for establishing procedural controls, such as SOPs, to address nontechnical requirements.

What types of records are considered 'regulated records' in the context of Cary UV Workstation?

Regulated records include methods, batch result files, associated audit trails, electronic signatures, and method and result reports.