Gel electrophoresis: aiding compliance with FDA 21 CFR Part 11

20th March 2017

Posted By Paul Boughton

Analyse 1D gels and Western blots with compliance to GLP/GMP regulations with the help of CLIQS 1D 21 CFR

Gel electrophoresis of proteins and DNA are techniques common to all labs.

For labs which need to meet FDA approval electronic records must have secure storage, audit trails and electronic sign offs.

With CLIQS 1D 21 CFR all the tools for comprehensive gel quantification are available within a version control tool to aid compliance.

The image analysis module is CLIQS 1D – Core Laboratory Image Quantification Software. Highly developed algorithms accurately detect lanes and bands.

Calibrate bands using molecular size standard lanes and derive accurate quantitation from known band volumes. Set up automated lane and band detection to increase objectivity and speed up analysis.

To ensure data security CLIQS 1D 21 CFR uses Windows security usernames and passwords with set privileges to allow access to only given individuals – Supervisor, User and Viewer.

Images and analysis are stored in a secure folder and audit trails are created to identify who accessed the image/analysis and what actions were taken during the analysis.

All analyses require electronic sign off by a supervisor which then locks the editing of the image.





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