Computer Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10.a. The FDA requires validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems. 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 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.

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.

Our validation specialists can validate your software, database or computer system in less time and for less money than hiring temporary contractors or permanent validation staff. We will work to complete your validation within your project deadlines. We can validate your systems on-site or off-site. Ofni Systems will analyze your programs, identify the highest risk sections and focus testing on those sections of the program.

• Validating Computer Systems
• Validating MS Access Databases
• Validating MS Excel Spreadsheets
• Validating Web Pages and Web Applications
• Validating Mi-Co User Forms

Key Benefits of Using Ofni Systems Validation