Beruflich Dokumente
Kultur Dokumente
BoehringerIngelheim
Abhishek Goel (865008)
Life Sciences/ Computer System validation
abhishek23.g@tcs.com
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Table of Content
1.
Introduction .............................................................................................................................................................. 4
1.1
2.
1. Introduction
The principle of testing every requirement became erstwhile after the introduction of Risk Based Approach which
specifies that every requirement shall be tested depending upon the risk priority i.e. High, Medium or Low.
Risk Priority
High
Level of Testing
Extensive testing with all positive and negative scenarios including boundary
testing
Only positive scenarios may be tested
No Formal Testing is required
Medium
Low
Business
Impact
Low
Medium
High
High
Medium
Low
Risk Likelihood
Example:- If Business Impact of a requirement is High and Likelihood of Risk Occurrence is Medium, then Risk Class
for this requirement will be 1.
Risk Class
High
Medium
Low
Medium
High
High
Low
Medium
High
Low
Low
Medium
Risk Detectability
Example:- If Risk Class for a requirement has been identified as 1 (using matrix in step 1) and Risk Detectability for
the same requirement is High, then Risk Priority for this requirement will be Medium.
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