Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

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Let's be honest. Your business probably relies on thousands of Excel spreadsheets that were created by employees long departed and modified by others many, many times.

Imagine having to validate all of them.

This report details the best practices you need to create a spreadsheet validation plan, including:

  • How to determine which spreadsheets actually need to be validated to comply with the FDA
  • How to maintain control of your data in the cloud
  • How to incorporate a validation plan into your traditional QA processes
  • How to create test scripts to validate your spreadsheets
  • How to plan, manage and resource an effective project and not see scope creep

And as a bonus, we’ve also included two white papers on spreadsheet design, verification and validation, and use and storage in single- and multiple-user environments. Written by the FDA’s own Dennis Cantellops, the quality assurance manager of the San Juan, Puerto Rico District FDA Office, these papers tell you exactly how the FDA handles its own spreadsheets, so you'll know what it expects you to do with yours.

Meet the Expert

David Harrison is a principal consultant with CSV Compliance Limited who specializes in pharmaceutical med tech compliance and computer system validation. Harrison has managed the introduction and implementation of 21 CFR Part 11 and computerized system validation projects for many key blue-chip clients, including more than 250 spreadsheet validation projects. Harrison has held a number of quality assurance and consultancy positions within the drug, biotech and device industries. Previously he was responsible for spreadsheet validation and computer system validation for ABB Consulting.

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Table of Contents

  • What Needs to be Validated
  • Regulatory Compliance
  • Project Planning and Reporting

View the entire TOC

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