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Image Analysis Resources Library

A collection of educational articles and videos with the idea of sharing know-how, methods and tools with the scientific community.

21 CFR Part 11 Compliance Checklist

We have created this 21 CFR part 11 compliance checklist to ensure you are have the right checks in place to comply with the regulations.

Understanding FDA 21 CFR part 11 compliance

Companies in a GMP/GLP pharmaceutical environment who need to comply with the 21 CFR regulations will need to become familiar with the following 21 CFR regulations. We will provide a brief overview of what part 11 contains and what it is referring to.

Capturing high dynamic range with gel doc systems

Recommendations for when capturing your images, comparing low and high dynamic range

The image saturation effect on image analysis

Recommendations for when capturing your images, comparing low and high dynamic range

How does spot detection and the spot map work in SpotMap?

Explaining the single spot map and how it works in SpotMap. Using one single spot map for all images allows you to correctly identify matching spots and missing spots on the blot…

How can I ensure the quantitative accuracy of my HCP coverage analysis?

Accurate quantitation is an important part of your HCP analysis. In this video we show you how automatic spot outlines in SpotMap obtain an objective, accurate and quantitative analysis

21 CFR Part 11 Compliance Guide for Version Control

The technical features of Version Control in regards to 21 CFR Part 11 (Subpart B – Electronic Records) and how these individual regulations can be satisfied to help your organisation comply with the Food and Drug Administration’s (FDA) 21 CFR 11 regulations.

How to Configure System Security in Windows for GxP Compliance

If you are operating in a 21 CFR Part 11 compliance laboratory then setting up Windows security becomes a major component in setting up your system. Below are some key takeaways we think will help ensure you, the administrator setup your Windows security correctly.

How to Configure Electronic Signatures for GxP Compliance

If you are using Version Control or any other software to aid 21 CFR Part 11 and using electronic signatures, it is important that your electronic signatures are setup is correctly in order to comply with the FDA 21 CFR regulations.

Tips for setting up your electronic signature for the FDA

If you are using Version Control or operating a 21 CFR Part 11 compliance laboratory and want to use electronic signatures there are certain protocols you must follow to declare that signatures used on records are legally binding equivalents to handwritten signatures.

How Imaging Effects Your Quantitative Gel Analysis

It will save further questions around “is my analysis quantitative?” or “why aren’t all my spots detected?”

(hint: analysing 8-bit JPEG images won’t give you accurate results).

Maintaining Reproducibility in HCP Coverage Analysis using 2D Gel and Western blots

Good image analysis will maximize the output of your HCP coverage experiment.

Who is this for? Analytical, QA/QC, process, bioassay or biologic development researchers.

Image Integrity and Processing For Gel and Western blots

When preparing a gel or blot image for use in scientific publications some adjustments to the image are considered appropriate.

However to avoid accidental image manipulation, we outline the image processing best practices for presenting images with integrity.