Validation in Thermal Analysis
The validation of equipment, processes and methods is a basic requirement that nowadays has to be met in most Industries; this includes the validation of computerized systems in general as well as analytical method validation.
Validation of Thermal Analysis Computerized Systems
Most analyses in modern analytical laboratories are performed using computerized measurement systems. From a validation point of view, one has to distinguish between the validation of the equipment and the validation of the analytical method. The first part of this handbook deals with the validation of computerized systems in general.
Method Development and Validation
The second part of the handbook covers topics related to method development and validation. Method validation ensures the quality and reliability of results, i.e. to demonstrate that an analytical method is suitable for its intended purpose. The practical examples focus on thermal analysis techniques such as differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), thermomechanical analysis (TMA) and dynamic mechanical analysis (DMA). Topics covered in the handbook, include:
- Validation of computerized systems
- Method development and validation
- Regulatory requirements
- The different qualification steps (DQ, IQ, OQ, PQ, AIQ)