Excel Spreadsheet Validation for FDA 21 CFR Part 11

Given the ease of their operations; spreadsheets find wide acceptance in a number of activities for laboratories. These include analysis, data capturing and reporting. Since these activities are part of a regulatory framework; companies using these spreadsheets need to comply with guidelines. These guidelines are set out in FDA 21 CFR Part 11, which deals […]

Excel spreadsheet validation to eliminate 483s

One of the basic issues for organizations in the regulated area is to carry out Excel spreadsheet validation to eliminate 483s. Why is this so? The FDA requires validation of electronic records, and this is a key requirement. The FDA has its set of regulatory requirements set out in 21 CFR Part 11. This code […]