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NanoDrop UV-Vis Analysis for Regulated Environments
The trusted Thermo Scientific NanoDrop One Microvolume UV-Vis Spectrophotometer can be used in regulated environments such as pharmaceuticals and biotechnology.
NanoDrop One Spectrophotometers help you quantify and qualify DNA, RNA, and protein samples in seconds with only 1-2 µL. You can obtain full-spectral data to confirm samples are qualified for downstream applications. The instruments come with Thermo Scientific Acclaro Sample Intelligence Technology to help you ensure DNA/RNA is pure enough for the next experiment. In addition, you can run the NanoDrop One instrument from a glove-compatible touch screen or a separate PC with the optional Security Suite software to generate data compliant with Title 21 CFR Part 11 regulation.
Operate from a Computer or Built-In Touch Screen
Touch Screen
- Built into the spectrophotometer
- Works even when wearing gloves
PC
- Runs on Windows 10 OS (versions 1607 and above)
- Connects to the instrument with an Ethernet cable
- Provides complete control (touch screen is disabled)
Same Applications on Instrument or PC
The same life-science applications and diagnostics scientists need can be driven from the touch screen on the instrument or the PC.
- dsDNA, ssDNA, RNA, Custom Factor, Protein A280, UV-Vis, and Custom Method applications
- The 3 instrument Diagnostic tests – Intensity Check, Performance Verification,
and Pedestal Image Check - History applications show previously measured sample data
Importing Data is Simple
The transition from touch screen to PC is seamless. Previous data stored in the PC Viewer Software or the instrument are easily transferred via the History screen to the PC Control version of the software.
Install PC Control Software
Proven compliance solution
Security Suite software operates on many different Thermo Scientific systems providing labs with compliant results in regulated environments. This time-tested solution is also available for the NanoDrop One/OneC Spectrophotometer.
Security Suite software integrates directly into the NanoDrop One PC Control Software making it easy for compliant labs to operate the trusted NanoDrop One/OneC Spectrophotometer.
The table below shows an example of how Security Suite manages regulatory requirements. To see a more detailed analysis, read 21 CFR Part 11 Compliance Document for Thermo Scientific Software.
See how the Security Suite Software meets US FDA Title 21 CFR Part 11 Requirements:
Requirement: Limit system access to authorized individuals
Feature: Administrators grant access through the Security Suite software. User account access is managed through the Windows login system.
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Requirement: Signed electronic records have 1) printed name, 2) date and time of signature, 3) meaning of signature
Feature: Experiments are signed immediately after completion. Users can revise, review, and approve experiments from the History page.
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Requirement: Secure, computer-generated, time-stamped audit trails to record operator actions and entries.
Feature: 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.
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Here is how to install the latest update to the administration policy file for Security Suite software which adds 21 CFR Part 11 compliance features for NanoDrop One spectrophotometers.
IMPORTANT: these instructions will update the application policies within the Security Administration software, but not update the software itself.
Please have your instrument serial number available for authentication before downloading files.
- Download the latest version of NanoDrop One software policies for Security Administration to the computer running the Security Administration software. (It’s the Security Administration portion of the software suite that will be updated.)
- Launch the Security Administration software.
- At the top left of the Security Administration window, choose File > Add Application.
- Locate the NanoDrop One.xml file on your computer and click Open. This will load in any new access controls and policies, but will leave any existing access control and policies unchanged.
- Configure any new access controls and policies as required.
- Save the configuration. Close Security Administrator.
NanoDrop One/One C Microvolume UV-Vis Spectrophotometer
The trusted NanoDrop One/OneC instrument helps you prevent costly delays with an enhanced understanding of sample quality.
- Quantify and qualify DNA, RNA, and protein samples with only 1-2 µL
- Get full-spectral data in seconds, PLUS Auto-Blank and Auto-Measure modes save time when measuring many samples
- Identify contaminants, obtain corrected concentrations, and enjoy success in your downstream applications
- User-friendly local control with sleek, standalone design – use with a PC or touch screen only
- Acclaro Sample Intelligence Software enhances early identification of contaminants
On-Demand Webinar: Maintaining Compliance in Pharma QA/QC Labs
The NanoDrop One/OneC Spectrophotometer system with Security Suite software is designed to meet 21 CFR Part 11 regulatory requirements. That means it can relieve the burden of for manufacturers.
Watch this webinar to see how two different instrument platforms – Microvolume UV-Vis and FTIR – help labs assure compliance in their processes. You’ll learn:
- How 21 CFR Part 11 is managed with innovative software controls
- The simplified workflows to create and deploy SOPs
- Why ongoing performance verification tests can give you peace of mind
The NanoDrop One Spectrophotometer (for DNA, RNA, and protein quantification) and the Thermo Scientific Nicolet Summit FTIR Spectrometer (for raw and finished material QA/QC) provide confidence when approaching your next audit.
