Qutem lab

Method validation

QuTEM performs validation studies of analytical protocols to assure the quality and consistency of Transmission Electron Microscopy (TEM) testing for our clients and their products. 

Our method validation studies are designed and executed according to international guidelines (ICH Q2 R2) to demonstrate with documented evidence that our cryogenic TEM (cryoTEM) or negative stain TEM (nsTEM) methods are suitable for determining a specified quality attribute. 

QuTEM Lab loading station


Assure the quality and legitimacy of the analytical results

Validation tests

according to ICH Q2 (R2) guidelines.



Intermediate precision




Dilutional accuracy




Validation process

The typical steps for a method validation study at QuTEM:

  • Establish a Method of Analysis (MoA, i.e., analytical protocol)
  • Perform pre-validation tests
  • Establish validation plan
  • Perform validation tests
  • Generate validation report
  • Validation study completed and MoA status updated to "validated"
GMP stamp_1

Want to know more about method validation studies?


Contact us

Related contents

This website uses cookies

Cookies consist of small text files. They contain data that is stored on your device. To enable us to place certain types of cookies we need to obtain your consent. At QuTEM AB, corp. ID no. 559456-1515, we use the following kinds of cookies. To read more about which cookies we use and storage times, click here to access our cookies policy.

Manage your cookie-settings

Necessary cookies

Necessary cookies are cookies that must be placed for basic functions to work on the website. Basic functions are, for example, cookies which are needed so that you can use menus on the website and navigate on the site.

Cookies for statistics

For us to measure your interactions with the website, we place cookies in order to keep statistics. These cookies anonymize personal data.