Process, Design and Equipment Validation is a method to establishing objective evidence that a process, design or equipment consistently produces a result or product meeting its predetermined specifications, required by 21 CFR 820.75. 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.
Ofni Systems validation specialists have experience working within the compliance requirements of established regulated companies. Our specialists are experts in industry validation standards and will produce validation documents which will meet or exceed your exacting standards. We can help you design Quality into all of your processes.
Ofni Systems uses FastVal to write validation documentation and execute Testing Protocols, which allows us to complete validation projects in 70% less time than traditional validation methods, with more time spent testing your software and less time preparing documentation. Our goal in all validation projects is to improve the quality and value of your computer system.
Ofni Systems can validate all of your systems and processes. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package. Ofni Systems will perform risk assessments to focus the validation effort on the most appropriate sections of your system.
Our validation experts will plan the validation approach and define the requirements. This includes identifying and describing the processes, specifying process parameters and the desired output. These requirements are documented as Functional and Design requirements.
Once requirements have been outline and documented, test plans are developed to demonstrate that all required system functionality is met and the system is properly secured. Our validation professionals will document a testing protocol, designed to demonstrate that your form meets all of your business requirements, plus regulatory requirements outlined by 21 CFR Part 820. As appropriate, this includes operational qualifications (OQ) and performance qualifications (PQ). Deviations, if they exist, will be reported and resolved.
Throughout the process, a Traceability Matrix is updated to ensure that all system requirements are addressed. If necessary, a formal risk assessment can be created to document decisions to focus validation testing. A Summary Report is also created at the end of the process to summarize any issues found during the validation project.