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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 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.Our validation professionals will document a testing protocol, designed to demonstrate that your system meets all of your business requirements, plus regulatory requirements outlined in 21 CFR Parts 210, 211, and 820.As appropriate, this includes installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ).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 c GMP.Process Validation applies to the production of pharmaceuticals and intermediate products.
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This can apply to manufactured medical devices as well as equipment used in the production of pharmaceuticals.
Such relationships between the various modes of validation are the basis of Quality Systems and reinforce the purpose of regulatory oversight: to ensure safe and effective products to promote and protect public health.
This includes identifying and describing the process or system, specifying parameters, and assessing the desired inputs and outputs.
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).We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package.
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