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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.
Brand: Implen CFR21-QHN-80
This item is not returnable.
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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
| Software | |
| NanoPhotometer NP80 | |
| IQ/OQ Package |
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Product Title
Implen 21CFR Part 11 Software for the NanoPhotometer with IQ/OQ package > For use with: NanoPhotometer NP80
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