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.
Stages of Validation testing Process: There is a notion as Independent Validation testing – If the validation tests are carried out by a third party, they are known as independent validation and verification (IV&V).
We use our proprietary tool Fast Val to write validation documentation and execute Testing Protocols, which allows us to complete validation projects in 70% less time than traditional validation methods.Failure to validate systems is one of the leading reasons a business is issued a 483.Ofni Systems can validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the software life cycle.Its goal is to validate and be confident about the product or system and that it fulfils the requirements given by the customer.
The acceptance of the software from the end customer is also its part.Computer Software Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, Section 4.