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.

• Factory Acceptance Tests
• Installation Qualification
• Operation Qualification. Final quality testing and validation of systems under operational conditions.
• Retrospective Validation of clients' older systems to modern regulatory standards. Retrospective validation can sometimes be occasioned by a change of use or extension to an existing plant.