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

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

Product Code. 17750248 Shop All Implen Products
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For Use With (Equipment):
NanoPhotometer C40
NanoPhotometer N120
NanoPhotometer N60
NanoPhotometer NP80
Unit Size:
Each
Product Code. For Use With (Equipment) unitSize
17750248 NanoPhotometer NP80 Each
17720248 NanoPhotometer N120 Each
17730248 NanoPhotometer N60 Each
17740248 NanoPhotometer C40 Each
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This item is not returnable. View return policy

Product Code. 17750248

Brand: Implen CFR21QHN80

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This item is not returnable. View return policy

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 NP80
Includes IQ/OQ Package

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