Method Validation

Method validation is a regulatory requirement in the pharmaceutical industry and in ISO 17025 accredited testing and calibration laboratories in several other industries like food or cosmetics. Under-performing or improper method validation creates a risk for a loss of accreditation, FDA Warning Letters, Form 483 observations, costly CAPA actions, lost sales, lost reputation, and unhappy customers. These are risks you can’t afford.

EffiChem answers these risks with a fully validated, powerful, easy-to-use method validation solution. With full data integrity and traceability measures built-in, EffiChem allows your lab to do complete method validation testing; including precision, accuracy, specificity, linearity, range, detection limit, quantitation limit, robustness testing, etc., in a simple, efficient, and effective way. EffiChem eliminates the chance for human errors common to paper-based method validation tasks, and prevents the data integrity problems inherent to doing this with Microsoft Excel. Reporting is accomplished with just one click, so documenting evidence and passing audits and inspections are no longer the hassle they were.

Using EffiChem for method validation reduces risk, lowers stress, and saves money. It’s a tool every lab can implement and can afford.

To learn more about how method validation and how EffiChem meets specific requirements click each screen shot for more.

Sample Screen Shots from EffiValidation

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