Ofni Systems Presentation at IVT’s 11th Annual Computer and Software Validation

Tyson Mew, president of Ofni Systems, will speak at the 11th Annual Computer and Software Validation conference in San Diego, CA, from April 21 through April 23. IVT’s 11th annual event showcases the validation process for computer systems and software. Computer and software validation (CSV) has remained a FDA hot button over the last decade in the GXP environment (manufacturing, laboratory and clinical).

Mr. Mew gave two presentations:

Prepare for FDA CSV Inspections
Review of Recent Enforcement Actions, 483’s and Warning Letters

The FDA has been expanding their audit programs and the number of observations related to validation problems has been steadily increasing. New requirements for Risk Assessments have been appearing, as well as a number of observations related to change control This session will focus on what the agency is looking for in your validation program by reviewing recent 483’s and warning letters related to computer system validations. Key points that will be covered include:

• Current FDA Requirements and Expectations for Validation
• Review of recent 483’s and Warning letters
• Consequences of Validation Gaps
• A checklist of the top observations to avoid

Automate Your CSV Process
Templates, Tools, & Tricks

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 CSV Practices

• Discuss why CSV is well-suited to automation
• Preparing templates for documents and certain types of systems
• Determine and execute your testing strategy
• Formalize your strategy in a Validation Master Plan
• Implement best practices for lean project management

Automation of CSV Document Generation

• Breaking down systems into discrete validatable objects
• Collecting testable requirements
• Automatically create your list of testable objects
• Generating Design Specifications directly from source code
• Integrating Risk Assessments into the process
• Automatic generation, tracking and updating of the Requirements Traceability Matrix

Test Cases and Test Plans

• How much testing is enough? Testing based on Risk Assessments
• Input testing, Challenge Testing, Unit & Workflow test cases
• Automating common test scripts with mini-test cases
• Create specific test cases for use with change control
• Auto-creation of test scripts from your requirements

Protocol Execution, Documentation and Managing Deviations

• Paper vs. Electronic execution
• Capturing actual results and screen shots for maximum effectiveness
• Generating, processing and closing test and script deviations

Interactive Exercise: Case Studies of CSV Automation Success Stories

Several case studies will be presented to demonstrate how different types of validation projects were automated using the techniques described above. We will also discuss how the FDA is using automation for spreadsheet validation in their own labs.

Ty Mew was available throughout the conference to discuss computer validation. Ty wants to thank all of our friends who stopped by our booth during the conference and looks forward to working with you in the future.

Any parties who would be interested in having Mr. Mew speak on these topics relating to computer validation are encouraged to contact Ofni Systems.

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