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

Product Code.	For Use With (Equipment)	unitSize
17720248	NanoPhotometer N120	Each
17730248	NanoPhotometer N60	Each
17740248	NanoPhotometer C40	Each
17750248	NanoPhotometer NP80	Each

Product Code. 17720248 Supplier Implen Supplier No. CFR21Q120

Description

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

• 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
• For Use With (Equipment): NanoPhotometer N120
• Includes: IQ/OQ Package

For research only