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Excel Spreadsheet Validation 101 — Proven Techniques for FDA Compliant Spreadsheets

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Tyson Mew, president of Ofni Systems, will speak at IVT’s 14th Annual Computer and Software Validation conference in Philadelphia, PA, from April 17 through April 19. On Thursday April 18, 2013, Ty Mew will be a featured speaker, giving the presentation:  Excel Spreadsheet Validation 101 — Proven Techniques for FDA Compliant Spreadsheets.

Learn how to Create and Validate Spreadsheets in FDA Regulated Environments

Easy-to-create and surprisingly powerful and flexible tools for data storage, spreadsheets are so common that they can almost seem invisible. However, GxP data stored within spreadsheets must be maintained in accordance with all applicable regulatory rules, especially 21 CFR 11; Electronic Records Electronic Signatures. The FDA is aware of the usefulness of spreadsheets, but expects controls to be in place to ensure that spreadsheets used in GxP processes are compliant with 21 CFR 11 and are validated. As FDA enforcement of 21 CFR 11 increases, uncontrolled spreadsheets represent an area of increased regulatory concern.

Institute for Validation Technology

IVT’s 14th Annual Computer and Software Validation conference is a three-day conference to discuss evolving computer and software validation practices. From the emergence of virtual networks, cloud computing and social media, the urgency of securing data integrity and complying with global regulations has never been greater. This conference aligns global regulations, best practices and case studies featuring the best CSV speakers to discuss developing, implementing and maintaining best validation practices in regulated environments.

Ty Mew and Ofni Systems will be available throughout the conference to discuss validation.

Registration information for the 14th Annual Computer and Software Validation conference is available.



Ofni Systems to Exhibit at IVT’s 18th Annual Validation Week

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Tyson Mew, president of Ofni Systems will be at IVT’s 18th Annual Validation Week in Philadelphia, PA on October 22-25. IVT has been in the forefront of promoting good validation practice for the last three decades. Today, new global regulations, technology advances and industry case models have shaped how to develop, implement and deploy validation procedures company-wide. Validation Week is a three-day event covering validation from A to Z, including; process, computer, equipment, method, facility, cleaning and much more. Ty Mew and Ofni Systems will be available throughout the conference to discuss validation methodology, demonstrate their validation automation tools and accept resumes from validation professionals.About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11/Annex 11 compliance and automating the validation process. Started in 1999, their products for compliant databases and spreadsheets are used by the FDA, pharmaceutical, biotech and medical device companies across the globe. 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 services using FastVal since 2006. The company’s products for computer validation, auditing and FDA submissions ensure that their clients meet all requirements for electronic records and electronic signatures. Ofni Systems provides live desktop support for superior customer support and training. For more information, call (919) 844-2494 or visit www.OfniSystems.com.

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



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



Spreadsheet Validation 101 : Create and Validate FDA Compliant Spreadsheets

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This page discusses a past conference.

Click here to learn more about spreadsheet validation.

 

Tyson Mew, President of Ofni Systems, and Ofni Systems, Validation Manager for Ofni Systems will speak at IVT’s 12th Annual Computer and Software Validation conference in Philadelphia, PA, from April 26 through April 28. Ty and Daniel will present Spreadsheet Validation 101 : Create and Validation FDA Compliant Spreadsheets on Wednesday, April 27 at 8:45 AM – 12:15 PM.

Easy-to-create and surprisingly powerful and flexible tools for data storage, spreadsheets are so common that they can almost seem invisible. However, GxP data stored within spreadsheets must be maintained in accordance with all applicable regulatory rules, especially 21 CFR 11; Electronic Records Electronic Signatures. The FDA is aware of the usefulness of spreadsheets, but expects controls to be in place to ensure that spreadsheets used in GxP processes are compliant with 21 CFR 11 and are validated. As FDA enforcement of 21 CFR 11 increases, uncontrolled spreadsheets represent an area of increased regulatory concern.

IVT’s 12th 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). Whether working in traditional pharmaceuticals, emerging biotechnology or the medical device industry, participants take away cutting edge information that can be immediately implemented.

Ty Mew and Ofni Systems will be available throughout the conference to discuss validation.

Spreadsheet Validation 101 : Create and Validation FDA Compliant Spreadsheets will cover:

Spreadsheets in GxP Environments

  • How the FDA validates their spreadsheets
  • Scale validation to spreadsheet functionality
  • Required spreadsheet validation documents
  • Design spreadsheets that facilitate compliance
  • Requirements for compliance with 21 CFR 11

Writing Spreadsheet Functional and Design Requirements

  • Write requirements that facilitate testing and detect common deviations
  • Document Data Entry, Formulas and Calculations
  • Documenting Macros

Test Protocols for Spreadsheets

  • Focused testing
  • Test spreadsheet inputs, outputs and compliance

Interactive Exercise – Validating a Spreadsheet

Participants examine a spreadsheet, determine the requirements for the spreadsheet and then create a suitable test case which verifies that the requirement has been implemented successfully. Participants are encouraged to bring their own example spreadsheets.

Bonus Materials

All conference participents will receive:

  • A checklist to determine if spreadsheets are compliant with 21 CFR 11
  • Sample spreadsheet validation package
  • Whitepaper — “MS Excel Spreadsheet Validation”
  • A trial copy of ExcelSafe that provides audit trails, password protection, user-level security and electronic signatures

About the Presentors

Tyson M. Mew is President of Ofni Systems, a software provider and Part 11 consulting firm. He has a strong background in software development and computer system validation, and has spoken at many conferences and workshops on Part 11. He is the creator of ExcelSafe and has worked on hundreds of client spreadsheets and desktop database systems to make them compliant. Mr. Mew regularly conducts training sessions for organizations to educate employees about the specific requirements of the rule and how to incorporate it into daily practices. He is an active member of ISPE, DIA, PDA, SQA and the PEERS Group.

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.



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

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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



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



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

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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

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



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

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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



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





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