Analytical Method Validation

The objective of any analytical measurement is to obtain consistent, reliable and accurate data. Validating analytical methods play a major role in achieving this goal.

We provide you with the strategies and specific recommendations for the validation of new methods developed internally or for the verification of compendial and standard methods, which can include:

• An overview of regulatory and quality standard requirements
• Strategies for implementation
• Information on test parameters, acceptance criteria and test conditions
• Recommendations for special applications, such as validation of bioanalytical methods, verification of compendial methods and transfer of analytical methods
• Development of System Suitability Tests and QC
• Creation of validation documentation (Validation Protocol and Validation Report)