Validation without the manual logic review
Spreadsheets skip formal development, so errors slip through, and inspecting formulas by hand is slow. XLValidator inspects logic visually, flags errors and inconsistencies, and generates specifications and IQ/OQ protocols automatically.
Benefits
- Specifications and IQ/OQ documents in a few clicks.
- Data integrity analysis before you validate.
- End users install the plug-in in minutes, with no IT help.
- No servers or database software required.
- Works with eInfotree Excel for Part11, or standalone.
Features
Automated Validation
Specifications and IQ/OQs in one click.
- Specification: Generated automatically for each spreadsheet.
- IQ/OQ: Documentation generated in one click.
- Criteria: Configurable specification and test case criteria.
- Change record: Date, time, user, cell, action, old and new values.
Spreadsheet Analysis
See problems before you validate.
- Formula and cell analysis: Based on criteria you select.
- Dependency mapping: Graphical map of file and cell dependencies.
- Formula error review: A wizard highlights errors, warnings and inconsistencies.
Checks and Compliance
Check entries and stay compliant.
- Cell validation: Configurable rules check manually entered data.
- eInfoTree Excel: Fully compatible for Part 11 compliance.
- Standalone: Also runs on its own for validation.
Overcoming 4 Challenges to the Use of GxP Compliant Spreadsheets
Spreadsheets are widely used across biopharmaceutical, pharmaceutical and other FDA-regulated industries, and they count as systems. When they affect product identity, strength, purity or safety, they must be validated and controlled.
Our white paper addresses four common challenges in meeting GxP quality requirements when using spreadsheets.
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