Production and QMS Software Validation - An Excel Example (Medical DeviceTraini)
Venue: Online Event
|Event Date/Time: Jan 18, 2012||End Date/Time: Jan 18, 2012|
If you use software as part of your Production or Quality Management System (QMS) you must validate the software. This requirement is not the same as for software built into a medical device. Production and QMS software requirements are in 21 CFRÂ§820.70(i). The most common occurrence of this kind of software involves an Excel spreadsheet. This webinar gives you practical advice on recognizing when this happens.
While the requirement applies to all production & QMS software, Excel spreadsheets are a good way to illustrate the methods. In addition, if you use Excel to create quality records, you may need to satisfy the Part 11 requirements.
The presentation explains the regulations in plain language and uses the FDA guidance documents to illustrate them. For validation, you will learn data checking methods in Excel and how to use them as part of a software validation approach. You will learn methods to document calculations in spreadsheets, prepare validation protocols, and produce validation reports.