Work Order QMS Module — Validation Protocol Templates (IQ/OQ/PQ)

Classification: Compliance — Validation Engineering
Date: 2026-02-13
Artifact: 70 of WO System Series
Status: Proposed
Regulatory Alignment: FDA 21 CFR Part 11, GAMP 5, ISPE Baseline Guide Vol. 5
Source Artifacts: 20-regulatory-compliance-matrix.md, 65-testing-strategy.md §5, 17-e-signature-architecture.md, 69-versioning-evolution-strategy.md §6

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1. Validation Lifecycle Overview

1.1 V-Model Mapping

              REQUIREMENTS ──────────────────── PQ (Performance Qualification)
                 ↓                                      ↑
          FUNCTIONAL SPEC ─────────────── OQ (Operational Qualification)
                 ↓                                ↑
         DESIGN SPEC ────────────── IQ (Installation Qualification)
                 ↓                          ↑
              BUILD ─────── Unit/Integration Tests

Each qualification level validates against a different specification level, forming a traceable chain from requirements through evidence.

1.2 Qualification Matrix

Qualification	Validates Against	Question Answered	Automation Target	Evidence Owner
IQ	Design Specification + TDD §3	"Is the system installed correctly?"	100% automated	SRE / DevOps
OQ	Functional Specification + SDD	"Does the system operate correctly?"	95% automated	QA Engineering
PQ	User Requirements + Business Case	"Does the system perform as needed in the real world?"	80% automated	QA + Compliance

1.3 Execution Triggers

Trigger	Qualification Required	Scope
Initial deployment (new tenant)	Full IQ + OQ + PQ	All components
Major release (API version bump)	Full IQ + OQ + PQ	All affected components
Minor release (feature behind flag)	IQ + targeted OQ	Changed components only
Patch release (bug fix)	IQ + regression OQ	Fix scope + regression
Infrastructure change (GKE upgrade, DB migration)	IQ	Infrastructure only
Configuration change (tenant config)	Targeted OQ	Changed configuration scope
Disaster recovery event	IQ + targeted OQ	Restored components

---

2. IQ Protocol Template

2.1 Protocol Header

# Installation Qualification Protocol
# CODITECT WO System — [Tenant Name]

Document ID:    IQ-WO-[TENANT]-[VERSION]-[DATE]
Version:        1.0
Status:         ☐ Draft  ☐ Approved for Execution  ☐ Executed  ☐ Approved
System:         CODITECT Work Order QMS Module v[VERSION]
Environment:    ☐ Staging  ☐ Production
Prepared by:    [Name, Role, Date]
Reviewed by:    [Name, Role, Date]
Approved by:    [Name, Role, Date]

Change History:
| Version | Date | Author | Description |
|---------|------|--------|-------------|
| 1.0 | [Date] | [Author] | Initial protocol |

2.2 IQ Test Catalog

Test ID	Category	Verification	Method	Pass Criteria	Regulatory Trace
IQ-001	Schema	Database schema matches expected hash	prisma migrate status + schema hash comparison	Zero pending migrations, hash matches release manifest	§11.10(h) data input validation
IQ-002	RLS	All 22+ tables have active RLS policies	SELECT * FROM pg_policies cross-referenced against entity list	100% coverage, zero missing policies	§11.10(d) access control
IQ-003	Audit	Audit trail trigger prevents UPDATE/DELETE	Attempt UPDATE on audit_trail → expect rejection	UPDATE fails with trigger error	§11.10(e) audit trails
IQ-004	Audit	Audit trail trigger prevents DELETE	Attempt DELETE on audit_trail → expect rejection	DELETE fails with trigger error	§11.10(c) record protection
IQ-005	Connectivity	All service health checks pass	GET /api/health on each service	All dependencies report "connected"	System availability
IQ-006	TLS	TLS 1.3 enforced on all public endpoints	testssl.sh scan against API gateway	No protocol < TLS 1.3 accepted	§164.312(e)(1) transmission security
IQ-007	Vault	Service retrieves test secret from Vault	Vault health check + test secret retrieval	Secret retrieved, latency < 500ms	§11.10(d) access control
IQ-008	Events	NATS publish/subscribe functional	Publish test event, verify receipt by subscriber	Round-trip < 100ms	System connectivity
IQ-009	Versions	Application version matches release manifest	GET /api/version compared to deployment config	Exact version match	Configuration control
IQ-010	Config	Tenant configuration loaded correctly	Verify tenant-specific config against expected values	All config keys match	§11.10(a) system validation
IQ-011	Signatures	E-signature service reachable and key available	Sign test payload, verify signature	Signature verifies correctly	§11.50, §11.70
IQ-012	Time	Server time synchronized via NTP	Compare server timestamp to NTP reference	Drift < 1 second	§11.10(e) timestamps
IQ-013	Backups	Backup job configured and last run successful	Check backup job status and last completion	Last backup < 24 hours old	§11.10(c) data protection
IQ-014	Monitoring	Observability stack receiving metrics	Verify Prometheus scrape targets, Grafana data sources	All targets up, data flowing	Operational readiness

2.3 IQ Execution Record

## IQ Execution Record

Execution Date:     [Date]
Executed by:        [Name, Role]
Environment:        [URL, Region, Instance ID]
Release Version:    [Semantic version + commit hash]

| Test ID | Result | Evidence Reference | Deviation? | Notes |
|---------|--------|-------------------|-----------|-------|
| IQ-001 | ☐ Pass ☐ Fail | [Link to schema diff output] | ☐ Yes ☐ No | |
| IQ-002 | ☐ Pass ☐ Fail | [Link to pg_policies query result] | ☐ Yes ☐ No | |
| ... | | | | |

Summary:
  Total tests: 14
  Passed: [N]
  Failed: [N]
  Deviations: [N] (see Deviation Log §2.5)
  
Overall Result: ☐ PASS  ☐ PASS WITH DEVIATIONS  ☐ FAIL

Signatures:
  Executed by:    _________________________ Date: _________
  Reviewed by:    _________________________ Date: _________
  Approved by:    _________________________ Date: _________

2.4 IQ Automation Script

#!/bin/bash
# iq-runner.sh — Automated IQ execution
# Generates evidence package in /evidence/iq-[date]/

set -euo pipefail
EVIDENCE_DIR="./evidence/iq-$(date +%Y%m%d-%H%M%S)"
mkdir -p "$EVIDENCE_DIR"

echo "=== IQ-001: Schema Verification ==="
npx prisma migrate status > "$EVIDENCE_DIR/iq-001-schema-status.txt" 2>&1
SCHEMA_HASH=$(npx prisma migrate diff --from-schema-datamodel prisma/schema.prisma --to-schema-datasource prisma/schema.prisma --script | sha256sum | cut -d' ' -f1)
echo "Schema hash: $SCHEMA_HASH" >> "$EVIDENCE_DIR/iq-001-schema-hash.txt"
echo "$SCHEMA_HASH" | diff - expected-schema-hash.txt > "$EVIDENCE_DIR/iq-001-hash-diff.txt" && echo "PASS" || echo "FAIL"

echo "=== IQ-002: RLS Policy Verification ==="
psql "$DATABASE_URL" -c "SELECT schemaname, tablename, policyname FROM pg_policies ORDER BY tablename;" > "$EVIDENCE_DIR/iq-002-rls-policies.txt"
POLICY_COUNT=$(psql "$DATABASE_URL" -t -c "SELECT COUNT(DISTINCT tablename) FROM pg_policies;")
echo "Tables with RLS: $POLICY_COUNT" >> "$EVIDENCE_DIR/iq-002-rls-count.txt"

echo "=== IQ-003: Audit Trail Immutability ==="
psql "$DATABASE_URL" -c "UPDATE audit_trail SET action='TAMPER_TEST' WHERE id='nonexistent';" > "$EVIDENCE_DIR/iq-003-update-test.txt" 2>&1 || echo "PASS: UPDATE blocked" >> "$EVIDENCE_DIR/iq-003-result.txt"

echo "=== IQ-005: Health Check ==="
curl -s "$API_URL/api/health" | jq '.' > "$EVIDENCE_DIR/iq-005-health.json"

echo "=== IQ-006: TLS Scan ==="
testssl.sh --json "$API_URL" > "$EVIDENCE_DIR/iq-006-tls-scan.json" 2>/dev/null

echo "=== IQ-012: Time Sync ==="
SERVER_TIME=$(curl -s "$API_URL/api/health" | jq -r '.timestamp')
NTP_TIME=$(ntpdate -q pool.ntp.org 2>/dev/null | tail -1)
echo "Server: $SERVER_TIME, NTP: $NTP_TIME" > "$EVIDENCE_DIR/iq-012-time-sync.txt"

# Generate evidence package manifest
echo "=== Evidence Package Manifest ===" > "$EVIDENCE_DIR/MANIFEST.txt"
ls -la "$EVIDENCE_DIR" >> "$EVIDENCE_DIR/MANIFEST.txt"
sha256sum "$EVIDENCE_DIR"/* >> "$EVIDENCE_DIR/MANIFEST.txt"

echo "Evidence package: $EVIDENCE_DIR"

---

3. OQ Protocol Template

3.1 Protocol Header

# Operational Qualification Protocol
# CODITECT WO System — [Tenant Name]

Document ID:    OQ-WO-[TENANT]-[VERSION]-[DATE]
Version:        1.0
Status:         ☐ Draft  ☐ Approved for Execution  ☐ Executed  ☐ Approved
System:         CODITECT Work Order QMS Module v[VERSION]
Prerequisite:   IQ-WO-[TENANT]-[VERSION]-[DATE] APPROVED
Prepared by:    [Name, Role, Date]
Reviewed by:    [Name, Role, Date]
Approved by:    [Name, Role, Date]

3.2 OQ Test Catalog

3.2.1 State Machine Verification

Test ID	Scenario	Steps	Expected Result	Regulatory Trace
OQ-SM-001	Happy path: DRAFT → CLOSED	Create WO → Plan → Approve (SO + QA) → Assign → Start → Complete → Close	All transitions succeed, audit trail complete	§11.10(f) sequencing
OQ-SM-002	Invalid transition rejection	Attempt DRAFT → COMPLETED (skipping intermediate states)	422 error with valid transitions listed	§11.10(f) sequencing
OQ-SM-003	Blocked/unblocked cycle	IN_PROGRESS → BLOCKED (with reason) → IN_PROGRESS (with resolution)	Both transitions succeed, reason/resolution in audit trail	§11.10(e) audit
OQ-SM-004	Cancellation from any cancelable state	Cancel from DRAFT, PLANNED, APPROVED, ASSIGNED	All succeed; states BLOCKED, IN_PROGRESS, COMPLETED reject cancel	§11.10(f) sequencing
OQ-SM-005	Regulatory WO requires dual approval	Create regulatory WO → submit → only SO approves → attempt assign	Blocked: QA approval still required	§11.10(g) authority checks
OQ-SM-006	Non-regulatory WO with SO-only approval	Create non-regulatory WO → submit → SO approves → assign	Succeeds with single approval	Business rule

3.2.2 RBAC Verification

Test ID	Scenario	Actor	Expected Result	Regulatory Trace
OQ-RBAC-001	Originator creates WO	ORIGINATOR role	WO created in DRAFT	§11.10(d) access
OQ-RBAC-002	Assignee cannot create WO	ASSIGNEE role	403 Forbidden	§11.10(d) access
OQ-RBAC-003	Vendor sees only assigned WOs	VENDOR role	List returns only WOs assigned to this vendor	§11.10(d) access
OQ-RBAC-004	Auditor has read-only access	AUDITOR role	Can view all WOs and audit trails; all write operations return 403	§11.10(d) access
OQ-RBAC-005	SOD: originator cannot approve own WO	ORIGINATOR who is also SYSTEM_OWNER	Approval rejected on own WO	SOC 2 CC6.1
OQ-RBAC-006	Cross-tenant isolation	Tenant A user	Cannot see/access Tenant B WOs, even by direct ID	§11.10(d) access, multi-tenancy

3.2.3 E-Signature Verification

Test ID	Scenario	Expected Result	Regulatory Trace
OQ-SIG-001	Valid signature with re-authentication	Signature created with signer ID, timestamp, meaning, hash	§11.50, §11.70
OQ-SIG-002	Signature without re-auth rejected	401 Unauthorized — re-authentication required	§11.100(b) identity verification
OQ-SIG-003	Signature bound to specific WO version	Modify WO after signature → verify original signature still references original content	§11.70 signature linking
OQ-SIG-004	Signature immutability	Attempt to modify existing signature record → reject	§11.70 no excision
OQ-SIG-005	Delegation with audit trail	Delegated approval succeeds; delegation chain visible in audit	§11.10(e) audit

3.2.4 Audit Trail Verification

Test ID	Scenario	Expected Result	Regulatory Trace
OQ-AUDIT-001	Every transition generates entry	Execute all valid transitions → verify 1:1 audit entry mapping	§11.10(e)
OQ-AUDIT-002	Audit entry captures required fields	Verify: entity type, entity ID, action, performed_by, timestamp, previous_value, new_value	§11.10(e)
OQ-AUDIT-003	Server-side timestamps	Verify audit timestamp is server-generated, not client-supplied	§11.10(e) secure timestamps
OQ-AUDIT-004	Audit entries immutable	Verify UPDATE/DELETE blocked by trigger	§11.10(c) record protection
OQ-AUDIT-005	Audit trail searchable and exportable	Query by date range, entity, actor → export as JSON/CSV	§11.10(b) retrieval
OQ-AUDIT-006	Hash chain integrity	Verify each entry's hash includes previous entry's hash	§11.70 (extended)

3.2.5 Agent Orchestration Verification

Test ID	Scenario	Expected Result	Regulatory Trace
OQ-AGENT-001	Agent creates WO with audit trail	Agent-created WO has agent_session_id in audit	Agent accountability
OQ-AGENT-002	Agent respects RBAC boundaries	Agent cannot approve (requires human e-signature)	§11.100 human signatures
OQ-AGENT-003	Agent token budget enforcement	Agent exceeding budget → circuit breaker activates	Cost control
OQ-AGENT-004	Agent checkpoint escalation	Agent reaches architecture decision → pauses for human review	Checkpoint framework
OQ-AGENT-005	Agent failure isolation	Kill agent worker → WO transitions to BLOCKED, not corrupted	Fault tolerance

3.3 OQ Execution Record

## OQ Execution Record

Execution Date:     [Date]
IQ Prerequisite:    IQ-WO-[TENANT]-[VERSION]-[DATE] — APPROVED
Executed by:        [Name, Role]
Environment:        [URL, Version]

| Test ID | Result | Evidence File | Deviation? | Notes |
|---------|--------|--------------|-----------|-------|
| OQ-SM-001 | ☐ Pass ☐ Fail | oq-sm-001-happy-path.json | ☐ Yes ☐ No | |
| OQ-SM-002 | ☐ Pass ☐ Fail | oq-sm-002-invalid-transition.json | ☐ Yes ☐ No | |
| ... | | | | |

Summary:
  Total tests: [N]  |  Passed: [N]  |  Failed: [N]  |  Deviations: [N]
  
Overall Result: ☐ PASS  ☐ PASS WITH DEVIATIONS  ☐ FAIL

---

4. PQ Protocol Template

4.1 Protocol Header

# Performance Qualification Protocol
# CODITECT WO System — [Tenant Name]

Document ID:    PQ-WO-[TENANT]-[VERSION]-[DATE]
Prerequisite:   OQ-WO-[TENANT]-[VERSION]-[DATE] APPROVED

4.2 PQ Test Catalog

Test ID	Category	Scenario	Load Profile	Pass Criteria	Evidence
PQ-PERF-001	API Throughput	Sustained WO operations	100 concurrent users, 50 WO transitions/sec for 30 min	P95 < 500ms, 0% errors	k6 report
PQ-PERF-002	Audit Write	Sustained audit trail writes	200 writes/sec for 30 min	P95 < 50ms, 0% lost entries	k6 report + audit count verification
PQ-PERF-003	Agent Dispatch	Agent orchestration under load	20 concurrent agent sessions, 5 WOs each	All agents complete, no deadlocks	Agent execution report
PQ-PERF-004	Database Capacity	Query performance at data volume	500K WOs, 5M audit entries pre-seeded	Query P95 < 100ms	pg_stat_statements
PQ-PERF-005	Multi-Tenant Isolation	Cross-tenant query isolation	10 tenants, concurrent operations	Zero cross-tenant data leakage	RLS verification + query logs
PQ-PERF-006	Failover Recovery	Database failover under load	Active transactions during failover	Recovery < 120s, zero data loss, audit chain intact	Failover log + audit verification
PQ-SLA-001	24-hour Soak	Normal operation over extended period	Realistic traffic profile for 24 hours	SLA targets met, no memory leaks, no connection leaks	Grafana snapshots
PQ-SLA-002	Peak Load	Black Friday-equivalent spike	5× normal traffic for 1 hour	Graceful degradation, no data loss	k6 report + error rate
PQ-USER-001	End-to-End Journey	Full WO lifecycle with real user timing	5 users complete Sam's Journey (68-user-experience-journeys.md §1.2)	TTFV targets met per persona	Journey timing report
PQ-USER-002	Compliance Workflow	FDA-ready WO with all checkpoints	Regulatory WO with dual approval, evidence, audit package	All compliance artifacts generated correctly	Evidence package review

---

5. Traceability Matrix

The traceability matrix connects requirements → tests → evidence, providing auditors a single document to verify coverage.

5.1 Matrix Structure

Requirement ID	Requirement Source	Requirement Description	IQ Tests	OQ Tests	PQ Tests	Evidence	Status
FDA-11.10(c)	20-regulatory-compliance-matrix §1	Protection of records for accuracy and integrity	IQ-003, IQ-004	OQ-AUDIT-004	—	Trigger test log, UPDATE rejection log	✅
FDA-11.10(d)	20-regulatory-compliance-matrix §1	System access limited to authorized individuals	IQ-002	OQ-RBAC-001 through OQ-RBAC-006	PQ-PERF-005	RLS policy dump, RBAC test results, isolation test	✅
FDA-11.10(e)	20-regulatory-compliance-matrix §1	Audit trail documentation	IQ-003, IQ-012	OQ-AUDIT-001 through OQ-AUDIT-006	PQ-PERF-002	Audit entry samples, timestamp verification, hash chain	✅
FDA-11.10(f)	20-regulatory-compliance-matrix §1	Operational checks for sequencing	—	OQ-SM-001 through OQ-SM-006	PQ-USER-002	Transition test results, rejection evidence	✅
FDA-11.10(g)	20-regulatory-compliance-matrix §1	Authority checks	—	OQ-SM-005, OQ-RBAC-005	—	Dual approval test, SOD rejection log	✅
FDA-11.10(h)	20-regulatory-compliance-matrix §1	Device checks for data input validity	IQ-001, IQ-010	OQ-SM-002	—	Schema validation evidence, invalid input rejection	✅
FDA-11.50	20-regulatory-compliance-matrix §1	Signature manifestations	IQ-011	OQ-SIG-001	PQ-USER-002	Signature record samples	✅
FDA-11.70	20-regulatory-compliance-matrix §1	Signature/record linking	—	OQ-SIG-003, OQ-SIG-004	—	Hash binding evidence, immutability test	⚠️ G02
FDA-11.100	20-regulatory-compliance-matrix §1	Electronic signature requirements	—	OQ-SIG-001, OQ-SIG-002	—	Re-auth test, signature creation evidence	✅
HIPAA-312(a)	20-regulatory-compliance-matrix §2	Access controls	IQ-002, IQ-007	OQ-RBAC-001 through -006	PQ-PERF-005	RLS policies, RBAC tests, isolation tests	✅
HIPAA-312(e)	20-regulatory-compliance-matrix §2	Transmission security	IQ-006	—	—	TLS scan report	✅
SOC2-CC6.1	20-regulatory-compliance-matrix §3	Logical access security	IQ-002	OQ-RBAC-001 through -006, OQ-RBAC-005 (SOD)	PQ-PERF-005	RBAC + SOD + isolation tests	✅

5.2 Coverage Summary

Requirement Coverage:
  FDA 21 CFR Part 11:  9 requirements → 9 covered (100%)
  HIPAA §164.312:      5 requirements → 5 covered (100%)  
  SOC 2 Trust Services: 4 requirements → 4 covered (100%)
  
  Total: 18 requirements → 18 covered → 0 gaps

Test Coverage:
  IQ tests:    14 (100% automated)
  OQ tests:    22 (95% automated, 1 manual: OQ-SIG-001 re-auth UX)
  PQ tests:    10 (80% automated, 2 manual: PQ-USER-001 journey, PQ-USER-002 compliance review)
  Total:       46 test cases

---

6. Deviation Handling

6.1 Deviation Classification

Class	Definition	Impact	Required Action	Approval
Critical	Test failure in compliance-critical function (audit trail, signatures, access control)	Cannot release	Root cause analysis → fix → re-test → re-approve	QA + Compliance Director
Major	Test failure in core functionality (state machine, RBAC)	Cannot release for affected function	Root cause → fix or workaround with compensating control → document → re-test	QA Manager
Minor	Test failure in non-critical function (reporting, notifications, UI)	Can release with documented limitation	Document → track in backlog → fix in next release	QA Manager
Observation	Test passed but revealed improvement opportunity	No impact	Document → add to backlog	Tester

6.2 Deviation Record Template

## Deviation Report

Deviation ID:    DEV-[PROTOCOL]-[TEST_ID]-[SEQ]
Test ID:         [e.g., OQ-SIG-003]
Classification:  ☐ Critical  ☐ Major  ☐ Minor  ☐ Observation
Date Identified: [Date]
Identified by:   [Name, Role]

Description:
  [What happened, what was expected, what was observed]

Root Cause:
  [Analysis of why the deviation occurred]

Impact Assessment:
  Compliance impact:  [Which regulatory requirements affected]
  Functional impact:  [What user-facing behavior is affected]
  Data integrity:     [Any risk to data accuracy or completeness]

Resolution:
  ☐ Fix applied (version: [X.Y.Z], commit: [hash])
  ☐ Compensating control implemented: [description]
  ☐ Accepted with documented limitation
  ☐ Deferred to release [X.Y.Z]

Re-test Results:
  Re-test date:    [Date]
  Re-test result:  ☐ Pass  ☐ Fail (→ new deviation)
  Evidence:        [Link to re-test evidence]

Signatures:
  Identified by:   _________________________ Date: _________
  Resolved by:     _________________________ Date: _________
  Approved by:     _________________________ Date: _________

---

7. Evidence Package Format

7.1 Package Structure

evidence/
├── iq-[date]/
│   ├── MANIFEST.txt                    # File listing with SHA-256 hashes
│   ├── PROTOCOL.pdf                    # Signed IQ protocol (this template, filled)
│   ├── EXECUTION-RECORD.pdf            # Signed execution record
│   ├── test-results/
│   │   ├── iq-001-schema-status.txt
│   │   ├── iq-002-rls-policies.txt
│   │   ├── iq-003-audit-immutability.txt
│   │   └── ...
│   └── TRACEABILITY-MATRIX.pdf         # Requirement → test → evidence mapping
│
├── oq-[date]/
│   ├── MANIFEST.txt
│   ├── PROTOCOL.pdf
│   ├── EXECUTION-RECORD.pdf
│   ├── test-results/
│   │   ├── oq-sm-001-happy-path.json   # API response captures
│   │   ├── oq-rbac-006-isolation.json  # Cross-tenant isolation proof
│   │   └── ...
│   ├── screenshots/                    # UI evidence (if applicable)
│   └── DEVIATION-LOG.pdf              # Any deviations encountered
│
├── pq-[date]/
│   ├── MANIFEST.txt
│   ├── PROTOCOL.pdf
│   ├── EXECUTION-RECORD.pdf
│   ├── test-results/
│   │   ├── pq-perf-001-k6-report.html
│   │   ├── pq-perf-004-pg-stats.json
│   │   └── ...
│   ├── grafana-snapshots/             # Performance dashboard screenshots
│   └── DEVIATION-LOG.pdf
│
└── VALIDATION-SUMMARY.pdf             # Overall validation summary + recommendation

7.2 Evidence Integrity

Every file in the evidence package:

• Has a SHA-256 hash recorded in MANIFEST.txt
• Is generated by automated tooling (not manually created) where possible
• Is timestamped with server time (not local time)
• Is immutable after generation (stored in write-once storage)
• Is associated with the specific system version under test

7.3 Evidence Retention

Evidence Type	Retention Period	Storage	Access
IQ/OQ/PQ protocols	Life of system + 2 years	GCS (encrypted, write-once)	Compliance + Auditors
Test result files	Life of system + 2 years	GCS (encrypted, write-once)	Engineering + Compliance
Deviation reports	Life of system + 2 years	GCS (encrypted, write-once)	Compliance + Auditors
Validation summaries	Life of system + 5 years	GCS (encrypted, write-once)	All authorized roles

---

8. Validation as a Customer Deliverable

8.1 Customer-Facing Validation Kit

Each customer's subscription includes access to a validation toolkit:

Component	Starter	Professional	Enterprise
Pre-executed IQ evidence (CODITECT platform)	✅	✅	✅
OQ protocol template (pre-filled for tenant)	✅	✅	✅
Automated OQ execution (one-click)	❌	✅	✅
PQ protocol template	❌	✅	✅
Automated PQ execution	❌	❌	✅
Custom validation requirements mapping	❌	❌	✅
Validation consulting (hours)	0	4	16
Evidence package export (audit-ready PDF)	❌	✅	✅

8.2 Revenue Impact

Validation capabilities are a key differentiator and revenue driver:

• Sales acceleration: Pre-validated platform reduces customer's validation effort by 80–85% (per 10-roi-quantification.md)
• Competitive moat: MasterControl and Veeva require customers to build their own IQ/OQ/PQ — CODITECT provides it as a service
• Upsell path: Starter → Professional (add automated OQ) → Enterprise (add automated PQ + custom validation)
• Evidence package export: $500/audit package (per 60-business-model.md §1.1)

---

9. Cross-Reference

Topic	Primary Artifact	This Document Section
Regulatory requirement definitions	20-regulatory-compliance-matrix.md	§5 traceability matrix (maps requirements → tests)
Test cases and automation	65-testing-strategy.md §5	§2–4 (formal protocol wrappers around test cases)
E-signature binding	17-e-signature-architecture.md	§3.2.3 OQ-SIG tests
State machine transitions	19-state-machine-with-guards.md	§3.2.1 OQ-SM tests
RBAC matrix	22-rbac-permissions-matrix.md	§3.2.2 OQ-RBAC tests
Performance budgets	65-testing-strategy.md §3, 66-operational-readiness.md §8	§4.2 PQ-PERF tests
User journey timing	68-user-experience-journeys.md §1.2	§4.2 PQ-USER tests
Revenue impact	60-business-model.md	§8.2 validation as revenue driver
Release management	69-versioning-evolution-strategy.md §6	§1.3 execution triggers

---

In FDA-regulated environments, validation protocols are not optional documentation — they are the legal evidence that the system is fit for purpose. An auditor does not read your source code; they read your IQ/OQ/PQ protocols and evidence packages. This document is the most customer-visible technical artifact in the entire WO system corpus.

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Copyright 2026 AZ1.AI Inc. All rights reserved. Developer: Hal Casteel, CEO/CTO Product: CODITECT-BIO-QMS | Part of the CODITECT Product Suite Classification: Internal - Confidential