CSA Strategy Advisor
Assess intended use, GxP applicability, Part 11, function-level risk, evidence, and assurance strategy.
Open resource →Find the right depth
Search CSVtoCSA
Search practical questions, regulations, systems, methods, scenarios, and assurance evidence across the platform.
15 results to start exploring
Test Selection Compass
Match scripted, exploratory, automated, boundary, negative, recovery, and supplier evidence to uncertainty.
Open resource →CSVDoc Reviewer
Review validation documents for candidate gaps while preserving human disposition and traceability.
Open resource →CSV and CSA — What changes in the way you work?
Computerized system validation, or CSV, establishes and maintains evidence that a computerized system is suitable for its intended use. Computer software assurance, or CSA, emphasizes confidence in the software’s use through risk-informed assurance activities. In practice, the terminology matters less than the quality of the reasoning and evidence.
Open resource →Intended use — Write down what people will trust
“The platform has dashboards, workflows, and reporting” describes capability. Intended use explains the job a person or process relies on the system to perform.
Open resource →Requirements — Describe observable behavior
“The system shall be compliant” cannot be tested as one behavior. Break the need into functions and controls that can be observed. Include inputs, conditions, outputs, exceptions, and the relevant record.
Open resource →Risk assessment — Explain the failure before the score
A useful risk statement connects cause, failure, consequence, and context: “If the LIMS interface drops the dilution factor, the receiving calculation may understate the result and support an incorrect acceptance decision.”
Open resource →Supplier evidence — Reuse it with a reason
Supplier evidence may include development and test records, release information, known-defect lists, security reports, configuration specifications, and service arrangements. Different evidence answers different questions. A security certification does not demonstrate that your CAPA routing is correct.
Open resource →Testing — Choose activities that can reveal the failure
Use a controlled sequence when exact preconditions, input values, expected results, and comparison are important. Examples include expiry at a defined time boundary, an acceptance calculation, or a signature remaining connected to an approved revision.
Open resource →Electronic records, audit trails, and signatures
Identify which information is needed to reconstruct the regulated activity: data, metadata, relationships, approvals, and relevant history. Then identify the applicable record obligations. FDA’s Part 11 scope guidance explains the relationship between electronic records and underlying record requirements, often called predicate rules. Applicability requires evaluation of the actual record and use. FDA Part 11 scope guidance
Open resource →Spreadsheets — Assess the calculation and its use
The important questions are what it calculates, how the result is used, who can alter it, and how errors are detected. A workbook without macros can still contain an incorrect formula, hidden row, broken reference, or misleading rounded result.
Open resource →Operating a system after release
A released system changes through supplier updates, configuration changes, user access, interfaces, data growth, incidents, and business use. Assign owners who can recognize when the original evidence no longer supports the current use.
Open resource →SaaS Assurance Playbook
A practical route from intended use and supplier evidence to release impact, local testing, and continued assurance for software you cannot freeze.
Open resource →AI Assurance Playbook
A controlled path from context of use and human authority to evaluation evidence, release boundaries, monitoring, and stop conditions.
Open resource →Spreadsheet Assurance Playbook
A proportionate method for deciding when a spreadsheet matters and how to control formulas, data, use, change, and retirement.
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