Security validation
Confirm the product is acceptably secure in its intended users, workflows, and operating environment.
PSLF-05G5Validation acceptedPhase 6 of 9
Gate
G5
Pending
Validation accepted
Target date
11 Dec 2026
Gate review
Open blockers
0
none recorded
Accountable
Product Owner
Clinical Safety, Privacy, Security, and Quality approve within authority
Validate security-related user needs and safe operation with representative users and production-equivalent configurations.
- Validate claims and foreseeable misuse in representative context.
- Residual risks are accepted only by authorized roles.
- Production-equivalent product
- Representative deployment and user profiles
- Approved validation protocol
- 1Validate security-related user needs, instructions, recovery behavior, update workflows, authentication, and operational controls
- 2Evaluate security-related use error and clinical workflow impact
- 3Assess all resulting changes for security, privacy, safety, and efficacy
- Product Security Validation Report
- Updated user needs and risk records
- Validation evidence and change-impact records
- Representative users and environment justifiedPending
- Security user needs validatedPending
- Resulting changes reverified/revalidatedPending
- Unresolved issues formally acceptedPending
- Accountable
- Product Owner accountable
- Supporting
- Clinical Safety, Privacy, Security, and Quality approve within authority
- Intended use (pending)
- Security claim (pending)
- Validation scenario (pending)
- Result (pending)
- Residual risk (pending)
- Acceptance (pending)
- Validation scenario coverage
- Unaccepted residual risks
- Claim-to-evidence coverage