XLValidator

XLValidator is a spreadsheet validation software tool developed by CIMCON Software, designed to help life sciences and FDA-regulated organisations perform rigorous logic inspections of Microsoft Excel spreadsheets. Because spreadsheets are widely used yet rarely subjected to a formal Software Development Life Cycle (SDLC), studies show they contain a disproportionately high level of errors compared to other applications. XLValidator addresses this risk by automatically highlighting errors, warnings, and potential issues in a highly visual manner, dramatically reducing the time and cost associated with manual spreadsheet validation.

The platform is aimed at teams in biopharmaceutical, pharmaceutical, and other FDA-regulated industries where spreadsheets that impact product identity, strength, purity, and safety must be validated and controlled to meet GxP quality requirements. XLValidator installs as a plug-in within minutes, requires no additional hardware, servers, or database software, and can be configured to align with an organisation's specific validation procedures.

Key Benefits

• Quick and easy generation of validation documentation for Excel spreadsheets with just a few mouse clicks.
• Analyse spreadsheets to ensure data integrity and reliability prior to validation.
• Plug-in software can be installed in minutes by end-users without IT assistance.
• No expensive servers or database software required.
• Fully compatible with the eInfotree Excel Module for 21 CFR Part 11 compliance.
• Powerful productivity and compliance tool that is easy to configure, use, and maintain.

Automated Spreadsheet Validation

• Automatic generation of comprehensive spreadsheet specification documents with a single click.
• Automatic generation of Installation Qualification and Operational Qualification (IQ/OQ) documentation with a single click.
• Records date, time, user ID, full user name, cell location, action type, old value, and new value for full audit trail support.
• User-configurable specification and test case criteria to match organisational validation procedures.

Spreadsheet Analysis Tools

• Formula and Cell Analysis: Powerful analysis of formulas and cells based on user-selectable criteria to identify potential calculation issues.
• Graphical Dependency Mapping: Visual mapping of file and cell dependencies to analyse structural integrity and surface possible errors.
• Formula Error Review: A graphical wizard that highlights formulas containing possible errors, warnings, and inconsistencies for verification purposes.
• Cell Validation: Configurable cell validation rules to check for data integrity and accuracy of manually entered data.

Compliance and Integration

• Fully compatible with the eInfotree Excel Module to support 21 CFR Part 11 compliance requirements.
• Can also be used in stand-alone mode without the eInfotree module for general spreadsheet validation purposes.

XLValidator is part of CIMCON Software's Desktop Series and is supported by additional educational resources, including a white paper covering four common challenges to the use of GxP-compliant spreadsheets in regulated industries.