FastVal Document Generator Improves Validation Process

Raleigh North Carolina – Monday, October 15, 2007 – Ofni Systems released the FastVal Document Generator. The FastVal Document Generator manages all phases of validation projects, including project planning, requirements gathering, risk assessment and protocol execution. FastVal is compliant with all FDA rules for electronic data, including 21 CFR Part 11 and ER/ES.

Features of the FastVal Document Generator include:

• Generates Any Validation Document – FastVal can generate any document your validation process requires. FastVal uses templates provided by Ofni Systems, or can use any existing templates. Documents can be generated as Microsoft Word or PDF files.
• Built in Requirement Traceability – Requirement traceability is built into FastVal documents. This provides automatic tracking of requirements and creation of Traceability Matrices.
• Electronic Protocol Execution – FastVal can facilitate protocol execution. Evidence of protocol execution is supported through text and screen capture. Electronic protocol execution uses electronic signatures and audit trails to guarantee data security. Protocols can also be exported for paper execution.
• Automatic Deviation Tracking – Deviations are created automatically when actual testing results do no match expected results. Deviation resolution can be customized to any existing procedure.
• Validation Project Management Tools – Project managers can see document and protocol status, follow deviations to resolution and track requirement completion.

"Validation should add value to a computer system," said Ofni Systems Validation Manager Daniel Waterman. "FastVal produces higher quality documentation, in far less time, which in turn allows us to spend our time testing software, rather than generating documentation. FastVal can be customized to any customer validation requirements, which allows us to meet and exceed all of our customers’ standards."

About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech and medical device companies across
the globe, while it's products for computer validation, auditing and FDA submissions ensure that their
clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training, and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.

Media Contact
Tyson Mew
President
Ofni Systems, Inc.
Phone: (919) 844 - 2494