Medical Device Production, Excel Spreadsheets, and Part 11 Compliance - ComplianceOnline (Medical Device Produ)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Apr 24, 2009
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Description

The FDA QSR (Part 820) requires software validation when computers are used as part of production or the quality system. These systems often generate quality records and may even use electronic signatures. As a result, the systems are also regulated under Part 11 covering electronic records and electronic signatures. One of the most common methods of generating these records is the Excel spreadsheet. The presentation covers the methods used to validate data in an Excel spreadsheet and how these methods can aid in software validation.

Venue

Additional Information

The FDA QSR (Part 820) requires software validation when computers are used as part of production or the quality system. These systems often generate quality records and may even use electronic signatures. As a result, the systems are also regulated under Part 11 covering electronic records and electronic signatures. One of the most common methods of generating these records is the Excel spreadsheet. The presentation covers the methods used to validate data in an Excel spreadsheet and how these methods can aid in software validation.