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.
GMP-certified
Assure the quality and legitimacy of the analytical results
Validation tests
according to ICH Q2 (R2) guidelines.
Specificity
Repeatability
Intermediate precision
Linearity
Dilutional accuracy
Range
Robustness
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"
