CSV vs CSA
Start with intended use. Put the most effort where a failure matters.
Decision: How do CSV and CSA support confidence in the intended use?
Practical Guides
Practical CSV, CSA and Software Assurance Guides
Find practical guidance for assessing a system, planning assurance activities, testing important functions, making a release decision and maintaining the validated state.
Start with the activity you are performing. Each guide explains the decision, the evidence to review, an example and the relevant regulations, standards or guidance.
Choose a lifecycle activity
Assess a system
5 guides in this activity.
GxP Assessment
Does the system support a GxP process or regulated record?
Decision: Does this use support a regulated activity, decision or record?
Intended Use
Say what the system does, who uses it and what depends on it.
Decision: What does the system do, for whom, and what depends on it?
Data Integrity for Computerized Systems
Start with the record people rely on.
Decision: Which controls preserve the record people rely on?
Electronic Records & Signatures
Understand the records and signatures relied on in the regulated process.
Decision: Which records, signatures and electronic reliance need controls?
Start with the essentials
New to CSV and CSA?
Read these in order, then choose the activity you are working on.
- CSV vs CSA
How do CSV and CSA support confidence in the intended use?
- Intended Use
What does the system do, for whom, and what depends on it?
- GxP Assessment
Does this use support a regulated activity, decision or record?
- Functional Risk Assessment
Which function failures matter, and what evidence will address them?