Basic Validation Concepts
Software Process Basics
Requirements
Evaluation / Testing
Configuration / Change Management
100
This validation model resembles geese in flight
V-model
100
This is the process, which defines project practices such as planning and monitoring.
Project Management
100
The highest level of requirements that begin to define the system in concrete terms.
SRS, System Requirements, Functional Requirements, etc.
100
This type of testing is represented by activities on the right side of the V-model.
Dynamic Testing
100
This is the process of moving work products from one phase or environment to another.
Promotion
200
The FDA says software must be validated for this. Hint: 21 CFR 820.30(g) and 820.70(i)
Intended Use
200
These are two common models used to drive software process development.
CMMI, CobiT, ISO 12207
200
This level of requirement may have no reference to a computer system.
User Requirements, BPR, etc.
200
What the FDA calls a Test Plan. Hint: 21 CFR 820.70(i).
Validation Protocol
200
This is the numbering sequence of various iterations of work products.
Versioning
300
These activities determine whether a system met its specifications.
Verification
300
This is the first step in documenting a process.
Workflow
300
Changing the “what” to “how.”
Design
300
This work product maps to the Test Plan but at the other end of the timeline.
Test Report
300
This is the record of all previous changes to a work product.
Audit Trail
400
This type of testing includes activities such as technical reviews, inspections, and walkthroughs of work products.
Static Testing
400
This is the grammatical structure of a strong process statement.
Present tense active voice (actor / action)
400
This is the map that helps demonstrate users got what they wanted and that every requirement was tested.
Trace Matrix / Analysis
400
They’re not testers, but they often wear the same name.
(S)QA
400
This is the point at which a work product must have all changes controlled.
After Initial Approval and Release
500
This meeting is required by the FDA, cross-functional in nature, and becomes part of the DHF.
Design Review
500
This is the FDA view of company processes during an investigation.
A company's process is the law for that company.
500
According to AAMI TIR-36, these three elements constitute intended use.
Purpose and intent, Software Use Requirements, Software Requirements
500
This type of testing ultimately determines whether a system meets its intended use.
Acceptance Testing, UAT, etc.
500
This is the group that adjudicates all proposed changes in a system.
Change Control Board (CCB)
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