Method validation depends on the type and purpose of analysis.

For example, the recommended validation procedure for PCR, followed by capillary gel electrophoresis of recombinant DNA, may consist of the following steps:

1. Compare precision by analyzing multiple (say, six) independent replicates of reference standards under identical conditions.

2. Data should be analyzed with a coe‰cient of variation less than a specified value (say, 10%)

3. Validation should be performed on three separate days to compare precision by analyzing three replicates of reference standards under identical conditions (once again the acceptance criteria should be a prespecified coe‰cient of variation).

4. To demonstrate that other analysts can perform the experiment with similar precision, two separate analysts should make three independent measurements (the acceptance criterion is once again a prespecified RSD).

5. The limit of detection, limit of quantitation, and linear dynamic range are to be determined by serial dilution of a sample. Three replicate measurements at each level are recommended, and the acceptance criterion for calibration linearity should be a prespecified correlation coefficient (say, an r² value of 0.995 or greater).

6. The molecular weight markers should fall within established migration time ranges for the analysis to be acceptable. If the markers are outside this range, the gel electrophoresis run must be repeated