Synthesize the real process
Interview operators, reviewers, IT, vendors, and quality owners. Filter the noise into the actual workflow the company says it follows.
FDA-compliant event governance
Compliance events become reviewable evidence.
Gaia is designed to support FDA compliance workflows as governed event systems. Human actions and device signals are captured by type, routed through customer-defined logic, recorded with audit context, and assembled into evidence packages for qualified quality, compliance, and legal review.
typed device events decision routing audit trail compliance evidence package
Aspiration, not clearance
Designed to support FDA-related controls — not to replace compliance judgment.
Gaia does not claim FDA approval, clearance, certification, or automatic compliance. The goal is to help teams build validated, customer-specific workflows that preserve evidence for qualified quality, compliance, and legal review.
The model
Compliance workflows are an event graph.
Every meaningful action becomes a node. Every routing decision becomes an edge. The evidence package is not reconstructed later; it is generated from the same governed graph that ran the compliance workflow.
Diagram
From raw event to compliance evidence package.
The same chain renders as an operator dashboard, supervisor review queue, audit export, or compliance evidence package. The data path stays the same.
1
Human / device event
Typing, scan, sensor read, signature, override, login, measurement, or chain-of-custody action.
event_id + device_type2
Gaia decision logic
Workflow state, SOP sequence, policy version, risk rules, identity, and review gates.
decision_id + route3
Controlled record
Actor, device, prior values, reason codes, attachments, signatures, hashes, timestamps.
evidence_hash + audit_id4
Compliance evidence package
Filtered case output with rule/SOP mapping, source records, investigation, sign-off, manifest, and export history.
case_id + evidence_line_idIntegration is the package
A barcode is not the whole story.
Batch IDs, SKUs, lots, serial numbers, case IDs, order numbers, and barcodes are tokens. Their meaning usually lives in vendor software, in-house systems, SOPs, and quality procedures. Gaia does not pretend a scan contains enough context by itself. The integration maps each token to the systems and rules that give it meaning.
System boundary Gaia connects to the defined process. It does not guess hidden proprietary data.
If the client system owns the product master, batch record, formula, case/order context, or vendor-specific workflow state, Gaia links to that source and records the decision trail around the interaction. The company defines the process; Gaia aspires to make it executable, auditable, and easier to review.
Bring paper into the system
OCR-assisted onboarding can scan SOPs, forms, labels, logs, and checklists into draft workflows for human verification instead of leaving paper teams behind.
Map tokens to source systems
Batch IDs, SKUs, lot numbers, serial numbers, barcodes, case IDs, and order identifiers stay linked to the proprietary systems that define their meaning.
Connect without replacing everything
Gaia integrates with vendor and in-house software, stores the visible event trail, and records where hidden context must be resolved by the client system.
Package the repeatable layer
The first implementation is services-heavy. What repeats becomes product: adapter patterns, event schemas, control matrices, review gates, and evidence templates.
Human process, coordinated
Gaia is not here to replace the people who know the work.
Most teams already know the process — it is just scattered across paper, spreadsheets, vendor screens, conversations, and tribal knowledge. Gaia captures that knowledge, turns it into governed workflows, and coordinates the handoffs so humans can focus on review, judgment, and improvement.
Teams describe how work really happens in plain language, interviews, forms, screenshots, and scanned documents.
Gaia turns that knowledge into human-readable wiki specs, skills, policies, routes, and review gates.
People still approve, investigate, sign, and decide. Gaia keeps the queues, records, reminders, and evidence trail coordinated.
Repeatable pieces become reusable adapters, templates, metrics, and governance patterns that get easier to deploy next time.
Gaia control plane
The page is grounded in how Gaia runs work.
The FDA-compliance package uses the same Gaia shape: authenticated actors, kernel policy decisions, typed service calls, durable timelines, protected secrets, governed deploys, and observable operations.
verifies the person, organization, role, session, and signature context
authorizes the action and records the policy decision before the route executes
carries typed events between compliance surfaces and Gaia services without ad hoc API shapes
keeps the operational timeline readable across web, chat, phone, and API surfaces
protects credentials, integration tokens, and classified operational secrets
ships the workflow with controlled deploys, health checks, logs, metrics, and traceability
How it works
One chain of custody for compliance workflows.
Capture the human event
Operators, reviewers, managers, field teams, and automated devices create typed events with actor, role, device type, location, and source context.
Route through Gaia logic
Gaia applies workflow state, policy, risk rules, SOP sequence, role authority, and review gates before the next action can happen.
Record the evidence
The event, decision, actor, device, rule version, evidence, signature, and outcome are recorded as an auditable chain of custody.
Generate the compliance evidence package
Events that need review are filtered into an evidence package: rule/SOP mapping, source records, investigation notes, signatures, attachments, and export history.
Device typing
The source determines the validation path.
A scanner, tablet, workstation, sensor, and chain-of-custody device do not carry the same context. Gaia uses device type to decide required fields, trust checks, routing, and evidence weight.
Operational workstation
Create, verify, review, override, release, and sign-off events tied to the active user session.
Barcode / label scanner
UDI, SKU, lot, serial, expiration, location, order match, mismatch, and retry events with device provenance.
Reviewer tablet
Supervisor review, approval, rejection, reason code, and electronic signature events.
Environmental sensor
Temperature, humidity, excursion, duration, affected inventory, quarantine, and disposition events.
Production / lab station
Procedure step, batch or case record, measurement, exception, and responsible-person events.
Chain-of-custody device
Handoff, failed delivery, return, receipt, and route exception events.
Routing logic
Rules turn activity into controlled decisions.
Each route writes its own explanation. A quality team can show why an event continued, paused, held inventory, opened CAPA, or entered reportability review under the customer-identified rule or SOP.
Expected action, expected user, expected state
Record the event and move the workflow forward.
Override, mismatch, missing field, or unusual sequence
Pause the path and require supervisor review or second verification.
Product quality, excursion, security, or safety signal
Create a controlled case, preserve evidence, and start investigation workflow.
Customer-configured reportability review
Generate a signed evidence package from source records and investigation evidence for qualified human review.
Severity logic
The same event can become a correction, hold, or field-action review path.
The customer-defined process determines the compliance path. Gaia records exactly where the event happened, what it affected, which rule evaluated it, and why the outcome stayed below product impact or escalated into product hold and reportability review.
Process correction / nonconformance review
The event can be corrected, documented, reviewed, and trended when the configured process and risk rules support that path.
Quality hold / investigation
Affected lot, batch, serial, SKU, case, or inventory is held while Gaia preserves the evidence and routes the investigation to the responsible reviewers.
Field action / reportability review
The issue crosses a customer-configured product, safety, or quality threshold, triggering escalation, formal sign-off, and evidence package generation for compliance review.
Record integrity
Every evidence line opens back to source.
A reviewer can start at an evidence line and walk backward: package → filter decision → case → source event → actor → device → policy version → evidence hash.
event_idactor_idrole_scopedevice_iddevice_typelocation_idroute_decision_idpolicy_versionevidence_hashsignature_idcase_idevidence_line_idPart 11-aligned record controls
- computer-generated audit trail
- actor, role, and authority check
- device source validation
- prior value preservation
- signature meaning and record link
- human-readable and electronic export
Compliance evidence controls
The package is designed around FDA-related record controls.
Gaia does not claim automatic compliance. It is designed to help produce controlled records, copies, audit trails, authority checks, device checks, signature links, retention evidence, and validation artifacts that qualified teams can review when a customer-identified rule requires a controlled record.
each controlled record is tied to the customer-identified rule, SOP, or requirement that needs it
requirements, route rules, and tests can show the configured system performs as intended
operator entries and actions are time-stamped, independent, retained, and reviewable
only authorized people can create, review, sign, export, or alter controlled records
source devices are identified so the validity of each input path is visible
signatures include name, timestamp, meaning, and a link back to the exact record
records are available as human-readable output and electronic packages for review
records remain protected and retrievable for the customer-defined retention period
compliance evidence package
The package is a governed view over the event graph.
Gaia filters the controlled record stream into review queues, tracks review state, binds signatures, and exports the package with the source trail attached so qualified teams can use it in their own compliance process.
Packaging for quality teams
Explain it to operators, auditors, quality teams, and investors the same way.
Capture every event. Route it through explicit logic. Store the decision trail. Generate reviewable evidence outputs from the same source of truth.