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FDA 21 CFR Part 11 Compliance for Spreadsheets

FDA 21 CFR Part 11 Compliance for Spreadsheets

In 1997, the U.S. Food and Drug Administration (FDA) published part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11). Part 11 specifically applies to all FDA regulated electronic records and electronic signatures (ERES) that are created, modified,...
The State of EUC Data Governance

The State of EUC Data Governance

Why is EUC Data Governance Important? Global Regulatory Focus Regulators worldwide have recognized EUC data governance as a key gap in many companies and have placed increased scrutiny in this area. This is especially true in financial services. Regulators are...
Five Worst Ways to Create an EUC Inventory

Five Worst Ways to Create an EUC Inventory

The important applications used for financial reporting, trading, liquidity analysis, and so on are known by many phrases and acronyms. They include “End User Computing” (EUC), “User Developed Applications” (UDA), “tools,” “calculators,” or plainly— spreadsheets....