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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
4 product options available for selection
Product selection table with 4 available options. Use arrow keys to navigate and Enter or Space to select.
Product Code. For Use With (Equipment) unitSize
17750248 NanoPhotometer NP80 Each
17720248 NanoPhotometer N120 Each
17730248 NanoPhotometer N60 Each
17740248 NanoPhotometer C40 Each
Use arrow keys to navigate between rows. Press Enter or Space to select a product option. 4 options available.
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This item is not returnable. View return policy
Product Code. 17750248 Supplier Implen Supplier No. 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

For research only

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