Implen 21CFR Part 11 Software for the NanoPhotometer with IQ/OQ package

Software upgrade and IQ/OQ package for NanoPhotometer models for compliance with 21 CFR part 11 FDA guidelines.

Product Code	Brand	For Use With (Equipment)
17720248	Implen CFR21-Q-120	NanoPhotometer N120
17730248	Implen CFR21-Q-60	NanoPhotometer N60
17740248	Implen CFR21-QHN-40	NanoPhotometer C40
17750248	Implen CFR21-QHN-80	NanoPhotometer NP80

Description

• License key provided on USB flash drive
• IQ/OQ documentation provided as Excel file on USB flash drive
• Incl. standard solution N-120-S, N-568-S and or Holmium Glass Filter and Neutral Density Glass Filter Set N-4080-HNF according to NanoPhotometer model
• Software is available for use on touchscreen and computers
• Authentication of user login information
• Ability to set Four Eye Administrator Rights, password guidelines and expiry dates
• Lockout access and re-authentication requirements after a period of inactivity
• System lockout upon unauthorized attempts to access software
• Individual Role Based Access Control for Administrator, Group, Power User and User roles
• Prevention of data tampering
• Generation of searchable audit trail log in human-readable format
• Tracking of changes and committed actions to user roles, account management, and system settings
• Ability to sign records electronically

Specifications

• Type: Software
• Includes: IQ/OQ Package

For research only