VMP-AD (CFT) 21 CFR Part 11 Compliant Instrument

FEATURES:

• Enhanced User Hierarchy: Incorporates four distinct user levels: System Admin, Admin, Manager, and Operator, ensuring stringent access control.

• Role-Based Access: Adheres to 21 CFR Part 11 guidelines with role-based access control for increased security.

• Password Management: Implements password protocols in accordance with regulatory standards.

• Automated System Time-outs: Enforces system time-outs during periods of inactivity to maintain compliance and security.

• Audit Trail Monitoring: Tracks all print and re-print actions, generating a comprehensive audit trail for accountability.

• Authenticated Results: Operator-authenticated results are time and date stamped, ensuring data integrity.

• Comprehensive Audit Trail: Records all user interactions in the Audit Trail with precise time and date details.

• Non-Editable Audit Trail: Safeguards the integrity of audit trail data by preventing any unauthorized editing.

TECHNICAL DETAILS:

The technical specifications remain consistent with the base Model VMP-AD:

• Temperature Range: 15°C above room temperature - 300 °C.

• Accuracy: Better than 0.5 °C.

• Temperature Resolution: 0.1 °C.

• Heating Rate: Last 10 °C rises 1 °C per minute.

• Power Supply: 230V, 50Hz, 500 W.

• Capillary: Length - 125 mm; Diameter: 1.4 – 1.6 mm.

• Display: 240 x 128 Graphic LCD.

• Input: Tactile Keyboard + PS - 2 keyboard.

• Printer Compatibility: Compatible with DOT MATRIX printer.

The Model VMP-AD (CFT) stands as a progressive iteration of the VMP series, ensuring 21 CFR Part 11 compliance with an array of secure and traceable features. By offering a hierarchical user structure, role-based access, and an unalterable audit trail, this instrument maintains data integrity and security while building upon the advanced functionalities of the base Model VMP-AD.