Ofni Systems Inc. services

Process, Design, and Equipment Validation are the formal processes for establishing objective evidence that systems consistently produce results or products meeting predetermined specifications, as required by the Federal FD&C Act and cGMP. Validation is an excellent tool to understand and maximize value from your business processes. Validation is also a compliance issue; the FDA requires validation to demonstrate that processes, designs and systems are in compliance with all regulations for Quality Systems. Failure to validate systems is one of the leading reasons a business is issued a 483.