Frequently Asked Questions about ExcelSafe

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These are frequently asked questions about ExcelSafe:

Q: Is ExcelSafe difficult to implement?
A: ExcelSafe is easy to implement:

Q: Can I open multiple spreadsheets?
A: ExcelSafe only allows one spreadsheet to be opened at any time. However, you can open multiple copies of ExcelSafe if you need to work in more than one regulated spreadsheet at a time.

Q: What are the ExcelSafe system requirements?
A: ExcelSafe requires MS Excel, version 2003 (or higher) and MS Access, version 2007 (or higher). The Enterprise version of ExcelSafe also requires SQL Server 2000 (or higher).

Q: With which versions of MS Excel does ExcelSafe work?
ExcelSafe works with all version of Excel 2007 and up, including, Excel 2007, Excel 2010,and Excel 2013. ExcelSafe works with all MS Excel spreadsheet and template formats, including .xls, .xlsx, .xlsm, and .xlsb.

Q: What were the results of the FDA’s use of ExcelSafe?
A: The San Juan District Laboratory investigation showed that ExcelSafe improved analytical spreadsheet application data integrity, security, and template accountability by using electronic signatures, audit trails, and other compliance and tracking features. Using ExcelSafe improved laboratory efficiency by decreasing the time required for internal document review. They praised the ease of using ExcelSafe, noting that ExcelSafe had produced significant cost and time savings, and stated they would continue to use ExcelSafe. A copy of the FDA Laboratory Information Bulletin is available for download.

Q: Which edition of ExcelSafe is right for me?
A: ExcelSafe is available in three editions; ExcelSafe Enterprise, ExcelSafe Professional, and ExcelSafe Standard. All three versions of ExcelSafe provide immediate 21 CFR 11 compliance to spreadsheets. ExcelSafe Enterprise is intended for situations where an organization has more than 50 users, ExcelSafe Professional is intended when 5–50 users can share a common network location, and ExcelSafe Standard is designed to be run from a single computer, shared between a few users.

Q: Does ExcelSafe run locally or from a shared drive?
A: Both the Enterprise and Pro versions of ExcelSafe will run from a network folder. The Standard version requires that ExcelSafe be loaded on the local drive.

Q: Is there anything added to the registry or desktop of the client computer?
A: There is nothing about ExcelSafe that needs to be referenced on the client machine, either in the registry or placed on a local drive. The client computer will need to have MS Excel properly installed.

Q: Can ExcelSafe create new compliant spreadsheets from our existing templates?
A: Yes. ExcelSafe can use your existing templates to create new compliant MS Excel spreadsheets. Templates can be added just as easily as any other spreadsheet and will be available for all users of ExcelSafe to create new workbooks with full compliance from the very beginning.

Q: Our organization does not have any validation standards for Excel spreadsheets (we are a small biotech startup) but we need them! Can you help us?
A: Yes. If you are starting a validation department, Ofni Systems can help you develop policies and procedures to validate spreadsheets.

Q: Are there restrictions on the number of users?
A: Information about number of users is located on the ExcelSafe Pricing Page.

Q: How much does ExcelSafe cost?
A: Pricing information is located on the ExcelSafe Pricing Page.

Q: Can you validate our spreadsheets for us?
A: Absolutely. Ofni Systems is a recognized industry leader in spreadsheet validation.

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