Key Benefits of Using Ofni Systems

• Experience – Our validation professionals have worked with large and small companies, in all aspects of FDA regulated fields from clinical trials to medical devices to biological products to medical imaging to generics.
• Quality – At Ofni Systems, we pride ourselves on our ability to meet and exceed our most demanding customers’ needs.
• Value – Validation increases the value of your software and improves the software development process.

FastVal Document Generator

• Reduces time spent on validation projects by up to 70%.
• More Testing, Less Time Documenting – FastVal allows us to spend more time testing your software and less time writing documents.
• Traceability – FastVal automatically tracks all requirements throughout the validation process. Project Managers can view current status of all documents within a project and requirements within a document.
• Electronic Protocol Execution – Validation testing can be executed and reviewed 100% electronically or documents can be exported to support paper execution. Our electronic testing package is documented with text and screen capture.
• Change Control – All validation documents can be stored by Ofni Systems in case system development requires change control or revalidation.

Validation Issues for Large Corporations


Ofni Systems will use your existing SOP's and templates, producing documentation identical to your existing documentation. Our specialists are experts in current industry validation standards, including GAMP 5. We understand why your policies exist and will meet or exceed all of your validation standards. If testing produces deviations, our professionals will collaborate with you to investigate and resolve program issues.

Validation Issues for Small Companies


Ofni Systems will guide you through the validation process. Our validation professionals can use our standard validation templates for your project. We can quickly and efficiently create a validation package for your software which will meet all of your regulatory needs. If your company requires written validation procedures, our validation professionals have experience in facilitating SOP development and can create validation SOPs designed to meet your company's needs.

Ofni Systems. Validation made simple.


Ofni Systems can meet all of your validation needs, easier and for less money than hiring your own validation staff. In addition to meeting regulatory and vendor requirements for software validation, you will have confidence in your software and control over your processes.

Contact Ofni Systems for an estimate. Validation packages are available.