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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.

49345.00 NOK - 55510.00 NOK

Specifications

Type Software
Includes IQ/OQ Package
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Products 4
Product Code Brand For Use With (Equipment) Price Quantity & Availability  
Product Code Brand For Use With (Equipment) Price Quantity & Availability  
17720248
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Implen
CFR21-Q-120
NanoPhotometer N120
49345.00 NOK
Each
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17730248
View Documents
Implen
CFR21-Q-60
NanoPhotometer N60
49345.00 NOK
Each
Please to purchase this item. Need a web account? Register with us today!
17740248
View Documents
Implen
CFR21-QHN-40
NanoPhotometer C40
55510.00 NOK
Each
Please to purchase this item. Need a web account? Register with us today!
17750248
View Documents
Implen
CFR21-QHN-80
NanoPhotometer NP80
55510.00 NOK
Each
Please to purchase this item. Need a web account? Register with us today!
Description

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

Specifications

Software
IQ/OQ Package
Videos
SDS
Documents

Documents

Product Certifications

For research only

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

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