FDAnews Management Report: Making Excel Spreadsheets Compliant

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When the FDA investigator reviews a company’s records, will it be able to demonstrate the integrity and security of all the Excel spreadsheets depended on? Make sure the answer is “yes” — with this definitive work on FDA spreadsheet compliance.

Making Excel Spreadsheets Compliant: Foolproof Methods for Validation
**FDAnews Management Report**

The problem of spreadsheet validation is nothing new. But it is persistent. In the past two years alone, inadequate spreadsheet validation has led to four warning letters (and countless 483 citations).

The simple fact is that Excel, great program though it is, wasn’t designed with the security needs of drug- and devicemakers in mind. Its shortcomings include inadequate audit trails and inability to prevent modifications by unauthorized users.

A business relies on Excel spreadsheets created by employees long departed and modified subsequently by dozens of hands. If these Excel spreadsheets have been diligently monitord over the years, there is nothing to worry about. But considering that some companies rely on hundreds — even thousands — of Excel spreadsheets, that’s not very likely. With Making Excel Spreadsheets Compliant: Foolproof Methods for Validation readers will discover how to:

  •     Conduct spreadsheet qualifications that meet FDA’s quality requirements
  •     Decide which works best — naked Excel spreadsheets, test macros or third-party software add-ons
  •     Spell out the skill sets that your validation team members need
  •     See how validation tools work
  •     Improve security and audit-trail capabilities

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As always, Making Excel Spreadsheets Compliant includes the basics. Count on it to help with:

  •     Predicting what the FDA expects from a validation program
  •     Building validation into your existing QA operation with techniques that                 work
  •     Crafting spreadsheet specs that get validation right — the first time
  •     And much more.

This management report is a must on every desktop for:

  •     Quality managers
  •     Data managers
  •     Validation professionals
  •     IS/IT managers
  •     Audit and compliance professionals
  •     Operations managers
  •     Laboratory managers

Making Excel Spreadsheets Compliant:
Foolproof Methods for Validation
**FDAnews Management Report**

FORMAT: Print or PDF
PRICE: $397

Online:     http://www.fdanews.com/Excel
By phone: 888-838-5578 or 703-538-7600

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
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