software validation


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Ofni Systems to Present at IVT’s 13th Annual Validation Week

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Raleigh North Carolina – Tyson Mew, president of Ofni Systems, will speak at IVT’s 13th Annual Computer and Software Validation conference in San Diego, CA, from April 16 through April 18.

IVT’s 13th Annual Computer and Software Validation conference is a three-day conference and exhibition to discuss the future of computer and software validation. Computer and software validation practices are evolving quickly with the emergence of virtual networks, cloud computing, SaaS and social media. The urgency of securing data integrity and complying with global regulations has never been greater. This industry landmark event aligns current global regulations and best practices delivered by industry experts.

Registration information for the 13th Annual Computer and Software Validation conference is available.Ty Mew and Ofni Systems will be available throughout the conference to discuss validation.

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



IVT Computer and Software Validation EU Press Release

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Raleigh North Carolina – Tyson Mew, president of Ofni Systems, will speak at the Computer and Software Validation EU conference in Dublin, Ireland from September 27 through September 29. The 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). Today, new approaches, such as EU’s Annex 11 and ASTM 2500, have taken the forefront in assisting organizations with CSV compliance. In this ‘create-your-own conference’ format, attendees build their own event to suit their specific validation needs, Whether working in traditional pharmaceuticals, emerging biotechnology or the medical device industry, participants take away leading edge information that can be immediately implemented.

Ofni Systems is sponsor of the conference. Ty Mew and Ofni Systems will also be available throughout the conference to discuss computer validation.

About Ofni Systems

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

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



Automate Your CSV Process – Templates, Tools, & Tricks

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This course will discuss:

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.

Presented by Tyson M. Mew, President, Ofni Systems, Inc.
11th Annual Computer and Software Validation
Presented by IVT



How to Validate Device and Computer Software

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Computer software validation has been a major issue for medical device manufacturers and is one of the leading causes of 483 observations, warning letters and product recalls. There are many different types of computer hardware and software found in the medical device industry, including:

  • COTS (Commercial Off-The-Shelf) applications
  • Custom in-house applications (databases and spreadsheets, web apps, etc)
  • Software embedded in medical devices
  • Software used to create or manufacture devices

All of the above must be validated for intended use and be under strict change control.  The risk to patients can be severe for even small software bugs, and the cost of legal actions or product recalls can be financially devastating. The following topics will be covered in detail:

  • A review of recent enforcement actions as a result of inappropriate computer system validations.
  • The basics of computer software validation and what is expected in any validation effort.
  • A presentation of Ofni System’s methodology for how we create functional requirements, design specifications and test cases.
  • Education for users about specific hot spots, including Change Control and Risk Assessments.
  • A discussion of new technologies for automated testing and electronic protocol execution.

e-Conference, Presented by the Clinical Device Group



Ofni Systems Presentation at IVT’s 10th Annual Computer and Software Validation Conference

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Raleigh, North Carolina – Tyson Mew, president of Ofni Systems spoke at IVT’s 10th Annual Computer and Software Validation conference on May 18-19, 2009. Mr. Mew gave two presentations:

  • Conducting a GAP Analysis of your CSV Program
  • Use Macros and Spreadsheets in a Regulated Environments

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



How to Conduct a GAP Analysis of your CSV Program

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Tyson Mew, president of Ofni Systems will speak at IVT’s 10th Annual Computer and Software Validation conference.

Presented by IVT





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