Ofni Systems to Present at IVT’s 16th Annual Validation Week

Raleigh North Carolina – Tyson Mew, president of Ofni Systems, will speak at IVT’s 16th Annual Validation Week conference in Philadelphia, PA, from October 25 through October 27. Ty will be presenting on Automate the Validation Process at 1:45 PM – 5:15 PM on Tuesday, October 26.

IVT’s 16th Annual Validation Week forum is a three-day conference and exhibition bringing together validation, quality and regulatory representatives who present their experiences in the validation arena including process validation, computer and software validation, method validation, cleaning validation and facility qualification (including equipment). Participants attend case study-driven workshops on implementation strategies for these specific areas of validation.

Ty Mew and Ofni Systems will be available throughout the conference to discuss validation. In addition, Mr. Mew will give presentation on automating the validation process.

Automate the Validation Process

Automation can be an excellent technique to improve the overall quality of your validation processes while decreasing the time spend on each validation project. Ofni Systems is a leader in validation automation. Ty Mew, the president of Ofni Systems, will give you all of the information you need to begin to automate your computer validation process. Key points that will be covered include:

Getting Started – Preparing to Automate your Validation Practices

• Prepare templates for documents and certain types of systems
• Formalize your strategy in a Validation Master Plan
• Implement best practices for lean project management

Automate the Generation of Validation Documents

• Collect testable requirements and lists of testable objects
• Integrate risk assessments into the process
• Automatic generation, tracking and updating of the requirements traceability matrix

Input testing, challenge testing, unit and workflow test casesTest Cases and Test Plans

• Automate common test scripts with mini-test cases
• Create specific test cases for use with change control

Protocol Execution, Documentation and Managing Deviations

• Paper versus electronic execution
• Capturing actual results and screen shots for maximum effectiveness
• Generating, processing and closing test and script deviations

Bonus Material

• Articles describing the methodologies discussed and how they were applied
• Sample validation documents created using automation

Registration information for the 11th Annual Computer and Software Validation conference is available.

About Ofni Systems
Ofni Systems is a leader in providing regulatory compliance solutions for pharmaceutical, biotech and medical device companies. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal validation software for generating and executing validation documents, and have been providing professional validation servicesusing FastVal since 2006. 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.

Ofni Systems is also highly acclaimed for their expertise with 21 CFR Part 11 compliance. They are frequent speakers on Part 11 at conferences, meetings and webinars, and have provided training for thousands of employees to help implement the requirements. 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