Security Software for NanoDrop One/OneC - enables 21 CFR Part 11 compliance – Witec AG

Art No | 840-329700
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The trusted NanoDrop One Microvolume UV-Vis Spectrophotometer can be used in regulated environments such as pharmaceuticals and biotechnology.

Description

NanoDrop One PC Control software allows analysts to operate the spectrophotometer from a computer as well as the built-in touch screen. Security Suite software, a proven compliance component of many other Thermo Scientific systems, integrates directly into the NanoDrop One PC Control software so analysts can confidently operate the trusted NanoDrop One/OneC spectrophotometer in compliance with regulatory requirements.

Security Suite software for NanoDrop One/OneC Spectrophotometers can integrate into new and older instruments so all users can be compliant with this new software.

NanoDrop One/Nanodrop OneC PC Software with 21 CFR Part 11 Compliance

 

 

Limit system access to authorized individuals.

Administrators grant access through the Security Suite software. User account access is managed through the Windows login system.

NanoDrop One/Nanodrop OneC PC Software with 21 CFR Part 11 Compliance

 

 

Signed electronic records have

  • printed name
  • date and time of signature
  • meaning of signature.

Experiments are signed immediately after completion. Users can revise, review, and approve experiments from the History page.

 

NanoDrop One/Nanodrop OneC PC Software with 21 CFR Part 11 Compliance

 

Secure, computer-generated, time-stamped audit trails to record operator actions and entries.

The Audit Manager creates an electronic audit trail of actions such as log ons, data creation, signatures, and more. Audit logs are available as needed.

Supplier

Thermo Fisher Scientific
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