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ExcelSafeTM

ExcelSafe provides MS Excel spreadsheets with security and 21 CFR 11 compliance features
including audit trails, electronic signatures and password protection.

ExcelSave by Ofni Systems
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ExcelSafe provides the technological tools for any MS Excel spreadsheets to be compliant with 21 CFR Part 11 in GxP environments. Start ExcelSafe, then open and operate spreadsheets normally. Once an MS Excel spreadsheet is opened, all compliance features work automatically; no changes are required to your existing spreadsheets.

ExcelSafe provides all of the following to your Excel spreadsheets:

Compliance with 21 CFR Part 11

ExcelSafe works with existing MS Excel spreadsheets. It does not change calculations, macros or VBA code. ExcelSafe provides the technological tools to comply with 21 CFR 11, including:
  • Limiting System Access (21 CFR 11.10d)
  • Program Time-Outs (21 CFR 11.10d)
  • Audit Trails (21 CFR 11.10e)
  • Authority Checks (21 CFR 11.10g)
  • Electronic Signatures (21 CFR 11, Subpart B)

Spreadsheet Security

  • Determine which users can view or edit spreadsheets
  • Prevent unauthorized access to spreadsheets
  • Prevent unauthorized changes to spreadsheet data
  • Customize security level settings for individual spreadsheets

How can Ofni Systems help you?

Additional Management and Developer Tools

  • Monitor all changes to all spreadsheets in real time
  • Query spreadsheet data with customizable search engine
  • Produce compliant spreadsheets
  • Continue to use your familiar templates and spreadsheets.
  • Create new Part 11 compliant spreadsheets with a click.
  • Facilitate spreadsheet validation in GLP, GCP and GMP environments.
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CDER indicating increased inspections for compliance with 21 CFR 11