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.
We have written (and executed) commercially available validation packages.
We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package.
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.