ExcelSafe


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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



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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