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Regulatory Products and Services

LI-COR offers an extensive range of regulatory products and services to supplement our imaging systems, software, reagents, and other services. Trust your regulated experiment with LI-COR and get secure and validated results with confidence.

To purchase a regulatory product or schedule a regulatory service, contact LI-COR regulatory services at regulatory@licor.com.

21 CFR Part 11-Ready Software

Secure, database-driven software that ensures traceability for access control, data acquisition, and analysis for regulated labs with a controlled workflow. Trained LI-COR technicians will install the software according to LI-COR standard operating procedures, interface the software with your existing IT infrastructure, and will work alongside your IT personnel to provide training for administration of the software.

For specific 21 CFR Part 11 compliance information, download the Image Studio Software 21 CFR Part 11 Compliance Guide.

Odyssey® Imager Verification Plates

Odyssey verification plates are designed and optimized to confirm consistent performance of your Odyssey CLx or Fc over time.

Installation Qualification and Operational Qualification (IQ/OQ) Services

Installation Qualification (IQ)

Establish confidence that your instrument(s) and software are compliant with applicable codes, approved design intentions, and has been setup in accordance with the manufacturer’s recommendations. IQ documentation is provided to establish qualification.

A certified LI-COR technician will confirm the installation of the instrument and complete the appropriate documentation, demonstrating that the system has been installed according to LI-COR standards. Recommended for labs that are audited externally.

Operational Qualification (OQ)

Validate the functionality of your instrument(s) and software according to established performance standards and applicable regulations. Performance documentation is provided to establish qualification.

A certified LI-COR technician will confirm that your instruments and software are performing according to LI-COR standards. Performance verification (PV) will also be completed with standard Plate Verification from LI-COR to ensure consistent performance of instruments and software over time. It is recommended that each instrument owner purchase their own verification plate. No additional charges will be incurred for a Manufacturer Audit. Recommended for labs that are audited externally.

Product Verification (PV)

Ensure that your instrument(s) and software perform consistently over time with a specifically-designed verification plate. Resulting performance data is analyzed and coefficient of variation (% CV) is provided with written product verification documentation.

Manufacturer Audit (MA)

Verify that LI-COR Biosciences is performing up to your standards. Complete an on-site audit of LI-COR Biosciences at our headquarters in Lincoln, Nebraska, USA as required by regulatory agencies or your organizational standard operating procedures (SOPs). LI-COR hosts auditors and provides necessary information for auditors and/or regulatory officials.

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