ExcelSafe to Offer Integration with Sharepoint and Agilent Platforms

Raleigh North Carolina – Ofni Systems announces that the upcoming release of their ExcelSafe Spreadsheet compliance software application will offer support for enterprise-level document management systems including Microsoft Sharepoint and the Agilent OpenLab Enterprise Content Manager (ECM).

“This is a giant step forward for the ExcelSafe application,” stated Ty Mew, President of Ofni Systems. “The next version will be a drop-in-place solution for both existing and new ExcelSafe customers that will offer the security, convenience, and document protection of a check-out/check-in module. Users can now travel with their spreadsheets while still maintaining full FDA 21 CFR Part 11 compliance.”

The ExcelSafe software has been used at the FDA and by hundreds of pharmaceutical, medical device, and clinical companies to ensure that their spreadsheets are compliant with FDA regulations for electronic records and signatures. ExcelSafe allows these companies to use the flexibility and economy of spreadsheets to perform FDA regulated activities. ExcelSafe provides users of Microsoft Excel with:

• User Security – Entry into spreadsheets requires a user name and password. ExcelSafe 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 – ExcelSafe comes with tools to track all changes to spreadsheets. Users can query results from any spreadsheet.
• Simplicity – ExcelSafe works automatically with existing spreadsheets and templates. Once a spreadsheet is opened in ExcelSafe, all compliance tools work automatically. Users operate Excel normally; there is no complicated interface to learn. ExcelSafe 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 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.