ALTA has assembled a team of dedicated Validation Scientists committed to the proper conduct and reporting of validations and stability studies according to all applicable Alta and Sponsor SOPs. A thorough method pre-qualification is run, prior to validation, in order to assess the method for precision and accuracy, matrix effects and assay ruggedness. A detailed validation plan is submitted to the client for approval prior to the commencement of work. A rigorous scientific review is conducted by senior laboratory staff to ensure that all validations are scientifically sound and meet or exceed the requirements outlined in the FDA's "Guidance for Industry, Bioanalytical Method Validations" issued in May, 2001.

(http://www.fda.gov/cder/guidance/4252fnl.pdf)