Spreadsheet Validation - OQOSAFE
Thanks to Oqosafe you can easily validate and protect your spreadsheets.
Software for the validation of spreadsheets
OQOSAFE is a software tool for the validation of spreadsheets or Excel sheets that provide functions for 21 CFR Part 11 compliance including Audit Trail, electronic signatures and password protection.
Oqosafe provides the functionality for spreadsheets to meet the requirements of control bodies including FDA or GxP in the European Union by creating electronic records and digital signatures.
It also provides all the necessary validation controls to protect and secure Microsoft Excel sheets, ensuring compliance with 21 CFR Part 11 in GxP environments. All compliance features work automatically; no changes to existing spreadsheets are required.
Benefits of Oqosafe
- Instant compliance: automatic protection for all your spreadsheets.
- No changes to existing spreadsheets: use your existing spreadsheets. No macros or modifications required.
- Easy to use: select your spreadsheet and use Excel normally, all the fulfillment functions work automatically.
- Easy to implement: minimal installation.
- Centralization of MS Excel workbooks: all MS workbooks centralized in the same location, avoiding duplication of workbooks.
- Monitoring of all changes in all spreadsheets in real-time: Real-time audit trail.
- Facilitates the validation of spreadsheets in GMP, GDP, GCP, and GLP environments.
Features of Oqosafe
- Full compliance with 21 CFR 11 for spreadsheets.
- Password protection – 21 CFR 11.10 (d) – All spreadsheets require a valid user ID and password for access.
- Audit Trails – 21 CFR 11.10 (e) – All spreadsheet changes (additions, edits and deletions) are logged.
- 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.
- Complete user management 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 and expiry requirements.