21 CFR part 11 package for UDK169-159

Software package upgrade for UDK 159 or 169 distillation units for compliant nitrogen determination according to FDA regulations.

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Achieve compliance to 21 CFR Part 11 provisions for nitrogen determination

21 CFR Part 11 Package upgrades UDK 159 or 169 software for Pharmaceutical, Cosmetic and Food industry laboratories that require compliance with FDA regulation.

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 for 21 CFR Part 11 basic requirements.

VELP 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 of 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

Models

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Model:

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21 CFR part 11 package for UDK169-159

Achieve compliance to 21 CFR Part 11 provisions for nitrogen determination

Models

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UDK 159

UDK 169

UDK 169 & AutoKjel