Computer Software Assurance for Production and Quality System Software

What the authority record establishes

The guidance describes a risk-based approach to establishing confidence in automation used for production or quality systems, including intended use, risk analysis, assurance activities, records, and appropriate testing.

Non-binding guidance describing FDA's current thinking

The exact official title, issuing body, jurisdiction, version or application record, and linked source define the scope of this page. Readers should not transfer the authority's status to a commercial product or infer transaction-, patient-, system-, site-, or organization-specific applicability from this summary.

Why it matters to this market

It gives laboratory and quality buyers a disciplined way to separate vendor evidence, configured intended use, process risk, assurance activity, unscripted testing, and retained objective evidence.

Affected operating stages

• Intended Use
• Risk Analysis
• Assurance Planning
• Testing
• Issue Resolution
• Record Retention

Capabilities to examine

Guided Laboratory Procedure And Worksheet Execution

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for guided laboratory procedure and worksheet execution.

Result Capture Calculation Review And Approval

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for result capture calculation review and approval.

Out-Of-Specification Deviation And Exception Workflow

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for out-of-specification deviation and exception workflow.

Electronic Signatures Audit Trails And Record History

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for electronic signatures audit trails and record history.

Role Identity Access And Segregation-Of-Duties Controls

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for role identity access and segregation-of-duties controls.

API Integration And Enterprise Interoperability

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for API integration and enterprise interoperability.

Deployment Administration Change Control And Validation Support

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for deployment administration change control and validation support.

Affected buyer audiences

• quality-system owners
• validation and assurance teams
• technology
• laboratories
• auditors

Implementation questions

• Which entities, products, populations, transactions, systems, sites, or jurisdictions are actually within scope?
• What is binding, what is guidance, and what is a technical or consensus standard?
• Which publication, adoption, effective, application, transition, and enforcement dates differ?
• Who owns legal, clinical, quality, regulatory, policy, or operational interpretation?
• How will a source revision affect open work and historical decisions?

Interpretation boundary

The guidance does not eliminate validation obligations, guarantee an outcome, or determine the right assurance activity for a specific configured use.