Regulatory Products and Services

Trust your regulated experiments with LI-COR and get secure, validated, traceable results with confidence. LI-COR offers an extensive range of regulatory products and services designed to help your lab become more compliant. Regulatory solutions supplement our imaging systems, software, reagents, and other services.

21 CFR Part 11-Ready Software

Image Studio™ 21 CFR Part 11 is a secure, database-driven software designed to help your lab comply with the Food and Drug Administration’s (FDA) 21 CFR Part 11 regulations. Regulated labs with a controlled workflow can ensure traceability for access control, data acquisition, and analysis.

A trained LI-COR technician will install Image Studio 21 CFR Part 11 software according to LI-COR standard operating procedures. They will also work with your IT personnel to integrate the software into your existing IT infrastructure and provide training for administration of the software.

For details on how Image Studio 21 CFR Part 11 addresses FDA regulations, see the compliance guide.
Looking to optimize your lab’s compliance with regulatory practices? Contact LI-COR regulatory services at regulatory@licor.com.

Image Studio 21 CFR Part 11 Features

  • Image archive
  • Electronic signature and approval
  • Time and date stamped change logs
  • Version control
  • System and record accessibility restriction
Note: Image Studio 21 CFR Part 11 is intended to address the technical controls needed for Part 11 compliance. You must ensure that the software is validated within your environmental context and that other elements necessary for Part 11 compliance (including procedural and administrative controls) are implemented.
Image Studio roles
Use defined roles to perform authority checks. Image Studio 21 CFR Part 11 allows you to define roles and determine which actions each role may perform.
Image Studio security
Limit software access to only authorized individuals. Only users with a valid username and password will be allowed to access Image Studio 21 CFR Part 11.
Image Studio image log
Keep a secure, time-stamped audit trail. Image Studio 21 CRF Part 11 lets you generate an image log to record all actions that affect the data.

Installation Qualification and Operational Qualification (IQ/OQ) Services

Installation Qualification (IQ)

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

A certified LI-COR technician will confirm instrument installation and complete the appropriate documentation to demonstrate that the system has been installed according to LI-COR standards.

Recommended for labs that are audited externally.

Operational Qualification (OQ)

Validate 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 demonstrate 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.

Installation qualification

Odyssey® Imager Verification Plates

Odyssey verification plates are designed and optimized to demonstrate consistent performance of your Odyssey Imager over time. The plates are imaged during an Operational Qualification but may also be used by you to ensure your Odyssey Imager is performing as expected.

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. Visit our headquarters in Lincoln, Nebraska, USA and complete an on-site audit as required by regulatory agencies or your organizational standard operating procedures. LI-COR hosts auditors and provides necessary information for auditors and/or regulatory officials.

Verification plate
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