MEDICAL DEVICES 2012 - Production and QMS Software Validation - An Excel Example

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Category Medical Device Software Validation; QMS software requirements; 21 CFR 820.70(i) requirements; Part 11 compliance; Excel data validation; validation protocols

Deadline: January 18, 2012 | Date: January 18, 2012

Venue/Country: Palo Alto, U.S.A

Updated: 2011-12-08 20:47:50 (GMT+9)

Call For Papers - CFP

Why Should You Attend:

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 CFR§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.

Areas Covered in the Seminar:

The QSR requirements for computers in production or the quality system.

- The Part 11 requirements for electronic records.

- Utilizing Excel's built in data validation methods.

- FDA Guidance documents and their expectations.

- Writing validation protocols and reports for Excel spreadsheet.