XLValidator

XLValidator Spreadsheet Validation Software

Due to their widespread availability and ease of use, spreadsheets often do not undergo a formal rigorous development process or formal methodology before they are released for production use. Studies show that spreadsheets contain a disproportionate level of errors as compared to other applications that undergo a formal Software Development Life Cycle (SDLC). Hence, it is important that a logic inspection be performed for spreadsheets similar to a software code review, so that all calculations and data flows are fully understood and tested before it is released to production. However, this can be very tedious and time consuming if done manually (which is why it is often not done).

The XLValidator Spreadsheet Validation Software performs a highly visual logic inspection of your spreadsheets and instantly highlights any errors, warnings or potential issues. It dramatically reduces the time and cost of spreadsheet validation by automatically generating specification documents and IQ/OQ protocols for your spreadsheets. The system is fully configurable to meet your validation procedures and needs, and can be implemented quickly and easily without the need for additional hardware or software.

Benefits
  • Quick and easy generation of validation documentation for your Excel spreadsheets with just a few mouse clicks.
  • Analyze your 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.
  • Easy to configure, use and maintain.
Features
Automated Spreadsheet Validation
  • Automatic generation of comprehensive spreadsheet specifications with a click of a button
  • Records date, time, user ID, full user name, cell location, action type, old value, and new value
  • Automatic generation of comprehensive Installation and Operational Qualification (IQ/OQ) documentation with a click of a button
  • User configurable specification and test case criteria

Compatible with eInfotree Excel Module for 21 CFR Part 11 Compliance
  • Software is fully compatible with the eInfotree Excel module for 21 CFR Part 11 compliance.
  • Can also be used in stand-alone mode without the eInfotree module for spreadsheet validation.

Spreadsheet Analysis Tools

Formula and Cell Analysis: Powerful formula and cell analysis based on user selectable criteria

Graphical Dependency Mapping: Graphical mapping of file and cell dependencies to analyze structural integrity and possible errors

Formula Error Review: Graphical wizard highlights formulas with possible errors, warnings and inconsistencies for verification purposes

Cell Validation: Configure cell validation rules to check for data integrity and accuracy of manually entered data


Overcoming 4 Challenges to the Use of GxP Compliant Spreadsheets

Today, spreadsheets are commonly used throughout the biopharmaceutical, pharmaceutical and other FDA-regulated industries. Spreadsheets are considered systems and when they impact data that affects product identity, strength, purity and safety, they must be validated and controlled. The purpose of this White Paper is to review the solution to four (4) common challenges when using spreadsheets to meet GxP quality requirements.

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