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Regulatory Products and Services

21 CFR part 11 Ready Software

21 CFR part 11 ready software is available for the Odyssey® CLx and Odyssey Fc Imaging Systems and the C-DiGit® Blot Scanner. To see how Image Studio™ 21 CFR part 11 ready software can help you achieve compliance, download this guide.

Note: We do not offer any consultation for 21 CFR Part 11 compliance.


Installation Qualification and Operational Qualification (IQ/OQ)


Installation Qualification (IQ)

Installation Qualification services are available for the Odyssey CLx, Odyssey Classic, Odyssey Sa, Aerius, and Odyssey Fc Imaging Systems and the C-DiGit Blot Scanner.

Installation Qualification occurs at installation of your instrument and confirms that the instrument and its components have been supplied as ordered and properly installed in your lab.

You will receive an IQ document with written signature that has all relevant activities and actions recorded at the time of performance, and a sticker (see image) that you may affix to your instrument. This sticker acts as a reminder to keep your instrument testing current.

Please contact regulatory@licor.com for details of this service and pricing.


Operational Qualification (OQ)

Operational Qualification services are available for the Odyssey CLx, Odyssey Classic, Odyssey Sa, Aerius, and Odyssey Fc Imaging Systems and the C-DiGit Blot Scanner.

Operational Qualification occurs once the instrument has been installed to demonstrate that the instrument functions according to its operational specifications.The Odyssey CLx Verification Plate is a 96-well plate used for Operational Qualification (OQ) on the Odyssey CLx or Odyssey Sa. It is used during the OQ procedure to ensure data consistency, but can also be used by the customer to ensure that the Odyssey CLx or Odyssey Sa is performing as expected over time.

The Odyssey Fc Verification Plate has two areas of illumination/detection that can be imaged during the Operational Qualification to confirm that the instrument is performing as expected and has not changed in performance over time.

You will receive an OQ document with written signature that has all relevant activities and actions recorded at the time of performance, and a sticker (see image) that you may affix to your instrument. This sticker acts as a reminder to keep your instrument testing current.

Please contact regulatory@licor.com for details of this service and pricing.


Performance Qualification (PQ)

Consultation for performance qualification (PQ) services are available upon request.

Please contact regulatory@licor.com.

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