Image Studio™ 21 CFR Part 11 Answer Portal
For example, "Connect Odyssey M to LI-COR Acquisition".
Description: Image Studio™ 21 CFR Part 11 is used to acquire and analyze high-quality images from Odyssey Imagers in labs regulated by the Food and Drug Administration’s (FDA) 21 CFR Part 11 regulations. For questions related to Image Studio Software, not Image Studio™ 21 CFR Part 11, visit the Image Studio Answer Portal.
Compatible Imagers: Odyssey DLx, Odyssey XF, Odyssey CLx*, and Odyssey Fc*
* Discontinued instrumentsCompliance Guide (PDF)
See how Image Studio™ 21 CFR Part 11 can help your organization comply with the FDA's 21 CFR Part 11 regulations.
Image Studio 21 CFR Part 11 is intended to address the technical controls needed for Part 11 compliance. It is the user’s responsibility to ensure that the software is appropriately validated within the context of the user’s particular environment, and to ensure that the other elements necessary for Part 11 compliance (including procedural and administrative controls) are implemented appropriately.
Client
Current Version: 5.6.2
Computer Requirements
The Image Studio 5.6.2 help system lists requirements that your computer needs to run the Client application.
More Information
To learn more about the Image Studio™ 21 CFR Part 11 Client, see the system overview in the Image Studio 5.6.2 help system.
Client Help System Versions
System Management Tool
Current Version: 1.4.7.32
Computer Requirements
The System Management Tool help system lists requirements that your server needs to run Image Studio™ 21 CFR Part 11.
More Information
To learn more about the Image Studio™ 21 CFR Part 11 System Management Tool, see the system overview in the System Management Tool help system.