Capability

Implementation

Validated systems only

Registry of systems in validated state (validation reference, GAMP category, HTTPS endpoint, periodic review interval); suspended, retired or review-overdue systems refuse actions

Registered action definitions

Versioned specs with JSON Schema inputs/outputs, HTTP binding, GxP impact and detectability; content-addressed by sha256; draft -> validated (QA e-signature, not the author) -> retired

GAMP 5 risk classification

Severity (patient safety, product quality, data integrity) x probability (software category, observed failure rate) -> risk class; x detectability -> priority; rationale stored with the request

Approval workflow

High priority: process-owner approval + QA approval by two different people; medium: QA approval; record-creating or irreversible: approval; only low-risk, reversible, non-record actions run autonomously

Part 11 e-signatures

Single-use challenge; OIDC re-authentication with nonce, fresh auth_time, accepted amr; manifest with printed name, time and meaning; Ed25519 signature over the record digest; rejection with reason

ALCOA+

Attributable, legible, contemporaneous, original, accurate, complete, consistent on requests; plus enduring and available (read-back) on records

Execution records

Input, output and raw-response digests, signatures, risk and policy outcome, ALCOA+ assessment; signed and verifiable at /v1/execution-records/{id}/verification

Audit trail

agentic-core hash chain, Ed25519-signed, one chain per process in PostgreSQL; /v1/audit/verification

Validation evidence

URS -> test traceability matrix with executed results (python -m gxp_agent_runtime.validation), produced in CI and attached to every release

Periodic review

Executions, failures, signatures, definition changes and audit integrity for a period; QA approval keeps or suspends validated state

Agent identity

agent-identity-fabric introspection and /v1/authorize (or offline verification of fabric credentials) plus local GxP policy; scopes gxp:read, gxp:execute:<action>

Agent protocols

REST, MCP tools over streamable HTTP at /mcp, A2A Agent Card and JSON-RPC at /a2a

Observability

Prometheus metrics, OpenTelemetry traces, JSON logs with correlation IDs, SLO and GxP alerts, Grafana dashboard

Endpoint

Caller

Purpose

POST /v1/systems, GET /v1/systems[/{id}]

System owner; any GxP role reads

Validated system registry

POST /v1/action-definitions, GET /v1/action-definitions[/{id}/{version}]

System owner; any GxP role reads

Versioned action definitions

GET /v1/actions

Agent (gxp:read)

Catalog of validated actions in the agent's scopes

POST /v1/actions/assess

Agent

Risk, ALCOA+ and policy preview

POST /v1/action-requests

Agent (gxp:execute:<action>)

Submit; executes or waits for signatures

GET /v1/action-requests[/{id}]

Approvers, QA, auditors; agent for its own

Approval queue and status

POST /v1/signatures/challenges, POST /v1/signatures

Approver, QA

Part 11 signing ceremony

GET /v1/signatures

Any GxP role

Signatures on a record

GET /v1/execution-records/{id}[/verification]

Agent (own), QA, auditor

Records and their verification

POST /v1/periodic-reviews, GET /v1/periodic-reviews/{id}

System owner, QA

Periodic review

GET /v1/audit/verification

QA, auditor

Audit-trail integrity

/mcp

Agent

MCP tools: list_gxp_actions, assess_gxp_action, request_gxp_action, get_gxp_request, get_execution_record

GET /.well-known/agent-card.json, POST /a2a

Agent

A2A discovery, message/send, tasks/get

GET /.well-known/jwks.json

Anyone

Keys that verify records, signatures and audit chains

Layer

Location

Container image

Dockerfile (non-root, read-only root filesystem compatible)

Helm chart

deployments/helm/gxp-agent-runtime (Deployment, HPA, PDB, NetworkPolicy, ServiceMonitor, projected token for the fabric)

Namespace and secret sync

deployments/kubernetes (restricted Pod Security, External Secrets)

Cloud infrastructure

deployments/terraform/{aws,azure,gcp}: managed PostgreSQL, KMS, secret store, WORM evidence storage, workload identity. AWS is the reference deployment