• 21 CFR Part 11 software package upgrade
• For use with Velp Scientifica UDK169-159
• For compliant nitrogen determination according to FDA regulations
• Helps you achieve full compliance with Subpart B – electronic records and Subpart C- Electronic Signatures of the FDA regulation Title 21 Part 11

The Velp Scientifica A00000429 21 CFR Part 11 is a software package upgrade for use with the Velp Scientifica UDK169-159. It helps you achieve full compliance with Subpart B, electronic records, and Subpart C, electronic signatures of the FDA regulation Title 21 Part 11.

Title 21 Part 11

The FDA's Code of Federal Regulations Title 21 Part 11 defines the requirements for using electronic records and electronic signatures on computerized systems. The integrity, reliability, and trustworthiness of electronic records must be fulfilled as to 21 CFR Part 11 basic requirements.

21 CFR Part 11 Package

Velp Scientifica’s 21 CFR Part 11 Package helps you achieve full compliance with Subpart B - Electronic Records and Subpart C - Electronic Signatures of the regulation:

• Track and record settings and any changes to settings with the system log function running permanently, serving as an audit trail
• Track who performs any operation as analysis results are automatically signed with the user information. Each user has a unique identification and electronic signature
• Ensure the quality and incorruptibility of recorded data with backup procedures. Exported files are protected from unwanted or improper alteration
• Ensure the right delegation of responsibilities at the right level with the user management system with three access levels