Control System Validation

Validation goes beyond normal system testing. It produces an audit trail of proof that the validated system operates exactly in accordance with its agreed specification. Validated systems are subject to strict change control and must be re-validated, in whole or in part, whenever changes are made. This strict regime ensures that validated systems are "tamper-proof" and can be relied upon to perform correctly throughout their whole range of permitted manufacturing conditions.

Validation of systems is particularly important in the pharmaceutical sector. Controlsoft Engineering designs and documents validation procedures in accordance with the requirements of the appropriate regulatory authority, generally either the FDA (Food and Drugs Administration). Witnessed testing is performed both before and after delivery to the client's site. Validation records are securely retained for a minimum of 10 years. Controlsoft Engineering's quality procedures apply throughout.