51 2014 - Software Process Verification and Validation

Instructor: Dev Raheja
Description:
The FDA's analysis of 3140 medical device recalls reveals that 7.7% of them are attributable to software failures. Of those software related recalls, 79%) were caused by software defects that were introduced when changes were made to the software after its initial production and distribution. Software verification and validation practices discussed in this guidance are a principal means of avoiding such defects and resultant recalls.
Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR §820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system
Why Should you Attend:
Software safety is a poorly understood science in the medical device industry. This knowledge is available from other safety critical industries and the FDA guidance makes it easier to implement.
Objectives of the Presentation:
Regulatory Requirements for Software Validation
Benefits of Software Validation
Quality System Regulation vs Pre-Market Submissions
Context for software validation
Software requirements in specifications
Verification and Validation process
IQ/OQ/PQ in software verification
Software development as part of system Design
Software is Different from Hardware
Time and effort required
Software life cycle verification
Software validation after a change
Validation Coverage
Validation of Off-the-Shelf Software and Automated Equipment
Independence of Review
Who can Benefit:
Software Engineering Managers and Engineers
Hardware Engineering Managers and Engineers
Entire QA Staff
Entire Regulatory Staff
R&D Engineers
Marketing Staff
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