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  1. 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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  2. 2009 SQA Annual Meeting Press Release

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    Raleigh North Carolina – Ofni Systems will be at the 25th SQA Annual Meeting, located at the Town and Country Resort and Convention Center in San Diego, California on April 19 – 24, 2009. Ofni Systems will have an information booth to inform SQA members about Ofni Systems compliance and validation services and products. Ty Mew will be available to answer questions about creating Part 11 compliant databases, Excel spreadsheet security and automating the validation process.

    For more information about the 25th SQA Annual Meeting, please visit their website at www.SQA.org.

    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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  3. ExcelSafe for Oracle Press Release

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    Raleigh North Carolina – Monday, March 9, 2009 – Ofni Systems announces ExcelSafeTM for Oracle. ExcelSafeTM provides MS Excel with password protection, user level security, audit trails and electronic signatures. “ExcelSafe for Oracle is an excellent tool for regulated industry. It provides the technological tools to make MS Excel compliant with 21 CFR Part 11,” said Ofni Systems President Tyson Mew.

    ExcelSafeTM for Oracle provides users of Microsoft Excel with

    • User Security – Entry into spreadsheets requires a user name and password. ExcelSafeTM has configurable user-level security which can restrict which users can open or spreadsheets and apply or remove electronic signatures.
    • Data Security – All changes to Excel are automatically recorded. The audit trail records the previous and new value of a cell, the date/time of a change, the user making the change and the reason data was changed. The audit trail also records other spreadsheet events, including addition or deletion of a worksheet. Electronic signatures prevent changes within a worksheet. Even deleted records are preserved on an unalterable audit trail.
    • Traceability – ExcelSafeTM comes with tools to track all changes to spreadsheets. Users can query results from any spreadsheet.
    • Simplicity – ExcelSafeTM works automatically with existing spreadsheets and templates. Once a spreadsheet is opened in ExcelSafeTM, all compliance tools work automatically. Users operate Excel normally; there is no complicated interface to learn. ExcelSafeTM supports any number of users and any number of spreadsheets.

    More information about ExcelSafe is available at www.OfniSystems.com/ExcelSafe.

    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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  4. 21 CFR Part 11 Compliance and Validation for MS Access Databases – 2/18/2009

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    Mr. Tyson Mew will address validation and 21 CFR 11 with regard to usage of Access databases. By properly securing your databases, you can allow a much wider audience to use and benefit from every database within the organization. The following topics will be covered in detail:

    • How to add audit trails to any part of the database
    • How to properly secure the data and code
    • Access database security settings for multiple users
    • Common settings to apply to limit user actions
    • Learn what the FDA will look for during audits
    • Managing change control and common mistakes to avoid
    • Details on when and where to use Electronic Signatures
    • Database testing and techniques for software validation

    Attendees will receive instructions for how to apply controls to their own access programs.  In additions, attendees may download sample code and validation documents for their own use.

    February 18, 2009
    e-Conference, Presented by the Clinical Device Group


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  5. How to Make Excel Part 11 Compliant

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    This conference addressed validation and part 11 with regard to your usage of Excel spreadsheets. You will learn what your options are and how to address the issues for the different categories of spreadsheets use. Tyson Mew will address:

    • What Excel is used for
    • Different categories of spreadsheets
    • Relevant regulations and history
    • Excel’s lack of compliance features
    • Where we are today with respect to Part 11 and enforcement
    • Options available to address Excel’s shortfalls
    • Applying those options to the different categories of spreadsheets
    • Managing the whole process
    • How to approach the issue if it’s an emergency and you have no money/time/resources

    e-Conference, Presented by the Clinical Device Group


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  6. 2009 Interphex Puerto Rico Press Release

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    Raleigh North Carolina – Monday, February 2, 2009 – Dennis Cantellops, QA Manager for the FDA Office of Regulator Affairs, San Juan District presented “Validation of Excel Spreadsheets in a Regulated Environment” at Interphex Puerto Rico on January 29, 2009.

    Many lab decisions being made based on the information in Excel spreadsheets. Excel spreadsheets can be as simple as a calculator or as complex as a custom made computerized solution. The use of Excel spreadsheets can become a regulatory nightmare if they proliferate unchecked within any organization. The FDA is aware of the usefulness of Excel spreadsheets, but expects controls to be in place to avoid wrong decisions being made based on “on-the fly” worksheets that were created for one-time use. This session addressed these concerns and offered strategies and approaches for response.

    Mr. Cantellops also discussed his experience using ExcelSafe with their regulatory spreadsheets. The FDA Office of Regulator Affairs, San Juan District is implementing ExcelSafe, Ofni Systems’ tool to provide audit trails, user level security, electronic signatures and other technological tools, allowing MS Excel spreadsheets to be compliant with 21 CFR 11.

    Ofni Systems is a leader in the field of spreadsheet compliance and validation. ExcelSafe provides the technological tools to MS Excel spreadsheets required for Part 11 Compliance, including audit trails, electronic signatures and user-level security.

    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 its 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


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  7. Ofni Systems to Present at IVT’s 10th Annual Computer and Software Validation Conference

    Raleigh North Carolina – Thursday, January 22, 2009 – Tyson Mew, president of Ofni Systems will speak at IVT’s 10th Annual Computer and Software Validation conference. The conference will be on May 18-20, 2009. Mr. Mew will give 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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  8. Ofni Systems Presentation “Proper Use & Validation of Excel Spreadsheets in an FDA Regulated Environments”

    Tags: |

    Raleigh North Carolina – Tyson Mew, president of Ofni Systems spoke at QCSV Inc. and the Regulatory Compliance Committee of the Medical Device Cluster Conference on the Proper Use & Validation of Excel Spreadsheets in an FDA Regulated Environments on October 30. The presentation was given in conjunction with Dennis Cantellops, QA Manager for the FDA Office of Regulator Affairs, San Juan District. The FDA Office of Regulator Affairs, San Juan District is implementing ExcelSafeTM, Ofni Systems’ tool to provide audit trails, user level security, electronic signatures and other technological tools, allowing MS Excel spreadsheets to be compliant with 21 CFR 11.

    The presentation started by outlining the FDA’s plans to increase inspectors and inspections, specifically focused on an increased interest in use of spreadsheets in regulated environments. Specific examples of audit observations relating to spreadsheets were discussed. Specific techniques to improve spreadsheet validation were discussed along with a general outline of a spreadsheet validation project.

    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


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  9. Ofni Systems Presentation at 2008 Validation Week, October 22-23, 2008

    Raleigh North Carolina – Monday, October 27, 2008 – Tyson Mew, president of Ofni Systems spoke at the 14th Annual International Validation Week conference in Philadelphia, PA on October 22 and October 23. Mr. Mew gave two presentations:

    FDA Validation Inspections and Latest Trends - The FDA is currently planning on increasing the number of inspectors and the number of inspections. This presentation reviewed the FDA inspection objectives and discussed which systems required validation. The presentation examined why validation is consistently one of the most common observations reported in FDA audits and which types of validations generate warning letters. Recent 483s relating to Computer System Validation, Equipment Validation and Cleaning Validation were discussed.

    Computer System Remediation & Validation for Regulatory Inspection – A Case Study - This presentation outlined a computer software validation compliance program, including FDA expectations for compliance with 21 CFR 11 and identifying which computer systems require validation. Specific techniques to improve computer system validation were discussed, focusing on which techniques worked best with which type of system. The presentation concluded with several case studies, exploring best practices to improve computer system validations.

    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


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  10. ExcelSafe V2.0 Press Release

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    Raleigh North Carolina – Ofni Systems has released ExcelSafeTM, version 2.0, which provides MS Excel with password protection, user level security, audit trails and electronic signatures. “ExcelSafe is an excellent tool for regulated industry. It provides the technological tools to make MS Excel compliant with 21 CFR Part 11,” said Ofni Systems President Tyson Mew. “ExcelSafe is spreadsheet security made simple.”

    ExcelSafeTM provides users of Microsoft Excel with

    • User Security – Entry into spreadsheets requires a user name and password. ExcelSafeTM has configurable user-level security which can restrict which users can open or spreadsheets and apply or remove electronic signatures.
    • Data Security – All changes to Excel are automatically recorded. The audit trail records the previous and new value of a cell, the date/time of a change, the user making the change and the reason data was changed. The audit trail also records other spreadsheet events, including addition or deletion of a worksheet. Electronic signatures prevent changes within a worksheet. Even deleted records are preserved on an unalterable audit trail.
    • Traceability – ExcelSafeTM comes with tools to track all changes to spreadsheets. Users can query results from any spreadsheet.
    • Simplicity – ExcelSafeTM works automatically with existing spreadsheets and templates. Once a spreadsheet is opened in ExcelSafeTM, all compliance tools work automatically. Users operate Excel normally; there is no complicated interface to learn. ExcelSafeTM supports any number of users and any number of spreadsheets.

    Version 2.0 includes additional tools for spreadsheet developers and system administrators:

    • Monitor changes to spreadsheets in real time.
    • Customize security settings for individual spreadsheets.
    • Improved tools for compliant spreadsheet development.

    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


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