ExcelSafe provides MS Excel spreadsheets with security and 21 CFR 11 compliance features
including audit trails, electronic signatures, and password protection. Click here to get ExcelSafe.
Download a copy of FDA Laboratory Information Bulletin 4524 Evaluation of ExcelSafe to Implement Part 11 Rules in FDA Analyst Workbook Files
Click Here To Download
Make any spreadsheet compliant with FDA, GxP, or EU requirements for electronic records and signatures, including 21 CFR 11 and Annex 11. ExcelSafe provides the technological controls to protect and secure Microsoft Excel spreadsheets, ensuring compliance with 21 CFR Part 11 in GxP environments. All compliance features work automatically; no changes are required to your existing spreadsheets.
- Instant Compliance – Automatic protection for all of your spreadsheets – even new ones!
- No Changes to Existing Spreadsheets – Use your existing spreadsheets. No macros or modifications required
- Simple to Use – Select your spreadsheet and use Excel normally; all compliance features work automatically
- Easy to Implement – Minimal installation and administrative requirements
- Powerful Data Mining Tools – Turn your existing spreadsheets into data collection tools
- Monitor all changes to all spreadsheets in real time
- Facilitates spreadsheet validation in GMP, GCP, and GLP environments
- Full 21 CFR 11 Compliance for Spreadsheets
- Password Protection – 21 CFR 11.10(d) – All spreadsheets require a valid User ID and password to access
- Audit Trails – 21 CFR 11.10(e) – All spreadsheet changes – additions, edits, and deletions – are recorded.
- User Level Security – 21 CFR 11.10(g) – Each user can be identified as being able to read or edit spreadsheets.
- Electronic Signatures – 21 CFR 11.10(j), 11.50, 11.100, and 11.200 – Users can sign each worksheet to prevent further changes.
- Search Engine with Customizable Results
- Query spreadsheet data
- Use comparisons and expressions for search
- View results through customized reports
- Complete User Administration Tools
- Define which users can create, view, or edit spreadsheets
- Multiple levels of security to customize each user’s privileges
- Configurable password complexity and expiration requirements
- Validation packages and Spreadsheet Validation Services are available
Ofni Systems help you?