GAMP5 Validation Documentation — Essert.MF¶

Document Information¶

Property	Value
Product	Essert.MF (Microfactory)
GAMP5 Classification	Category 4 — Configured Product
Regulatory Standards	GAMP5 (ISPE), FDA 21 CFR Part 11, EU Annex 11, GMP
Scope	Standard product validation (not project-specific)
Architecture Documentation	arc42 (source of truth for architecture)

V-Model Overview¶

The GAMP5 V-model structures validation activities. Left side defines specifications, right side verifies them.

                              VP-001
                         Validation Plan
                        /               \
                       /                 \
                      /                   \
              URS (9 docs)           PQ-001
         User Requirements      Performance
          Specification          Qualification
                    /                   \
                   /                     \
                  /                       \
           FS (9 docs)              OQ-001
        Functional Spec.         Operational
        (refs arc42/05,06)       Qualification
                  /                       \
                 /                         \
                /                           \
         DS (3 docs)                  IQ-001
       Design Spec.              Installation
       (refs arc42/04,08,09)     Qualification
                \                         /
                 \        RA-001         /
                  \   Risk Assessment   /
                   \                   /
                    \    RTM-001      /
                     \ Traceability  /
                      \   Matrix    /
                       \           /
                        ─────────
                        Essert.MF
                      Standard Product

Document Index¶

Validation Plan¶

ID	Document	Status
VP-001	Validation Plan	Draft

User Requirements Specification (URS)¶

ID	Document	Bounded Context	BR Mapping
URS-MFG-001	Manufacturing Process Management	Manufacturing	BR-01, BR-03
URS-PRD-001	Product Management	Product	BR-01, BR-05
URS-QUA-001	Quality and Statistics	Quality	BR-04
URS-ROB-001	Robot Control	Robot	BR-02
URS-WPC-001	Work Piece Carrier Management	WorkPieceCarrier	BR-03
URS-PAR-001	Parameter Management	Cross-cutting	BR-05
URS-SYS-001	System Configuration	System	BR-08
URS-INT-001	Multi-Protocol Integration	Integration	BR-06
URS-DAT-001	Data Integrity and Audit	Cross-cutting	BR-07, BR-08

Functional Specification (FS)¶

ID	Document	Corresponding URS
FS-MFG-001	Manufacturing Functions	URS-MFG-001
FS-PRD-001	Product Functions	URS-PRD-001
FS-QUA-001	Quality and Statistics Functions	URS-QUA-001
FS-ROB-001	Robot Control Functions	URS-ROB-001
FS-WPC-001	Work Piece Carrier Functions	URS-WPC-001
FS-PAR-001	Parameter Management Functions	URS-PAR-001
FS-SYS-001	System Configuration Functions	URS-SYS-001
FS-INT-001	Integration Functions	URS-INT-001
FS-DAT-001	Data Integrity Functions	URS-DAT-001

Design Specification (DS)¶

ID	Document	arc42 References
DS-001	Architecture Design	arc42/04, 05, 09
DS-002	Data Model Design	arc42/07, DATABASE_SCHEMA
DS-003	Cross-cutting Design Patterns	arc42/08, 09

Risk Assessment¶

ID	Document	Status
RA-001	GxP Risk Assessment	Draft

Requirements Traceability Matrix¶

ID	Document	Status
RTM-001	Full Traceability Matrix	Draft

Qualification Protocols¶

ID	Document	Verifies Against
IQ-001	Installation Qualification	DS
OQ-001	Operational Qualification	FS
PQ-001	Performance Qualification	URS

Templates¶

Template	Purpose
URS Template	New user requirement documents
FS Template	New functional specification documents
Change Request Template	Change requests to the standard product

Supporting Evidence (Archived)¶

Legacy technical documents created during initial development (Nov 2024 – Mar 2025) have been archived in docs/archive/. These are superseded by the GAMP5 structure but remain available as historical reference and supporting evidence.

Archived Document	Relevant GAMP5 Documents
SQL_TO_API_MAPPING	FS-INT-001, RTM-001
SQL_TO_REST_COMPLIANCE_ANALYSIS	RTM-001, OQ-001
APPLICATION_LAYER_TEST_PROGRESS	OQ-001, RTM-001
Testing	VP-001, OQ-001
DATABASE_SCHEMA	DS-002
GRAPHQL_API_STATUS	FS-INT-001
ARCHITECTURE_ANALYSIS	DS-001
TEST_COVERAGE_TH_PARAMETERS	OQ-001
PERFORMANCE_INDEX_ANALYSIS	PQ-001

ID Pattern System¶

Document Prefixes¶

Prefix	Document Type
VP	Validation Plan
URS	User Requirements Specification
FS	Functional Specification
DS	Design Specification
RA	Risk Assessment
IQ / OQ / PQ	Qualification Protocols

Bounded Context Prefixes¶

Prefix	Bounded Context
MFG	Manufacturing
PRD	Products
QUA	Quality & Statistics
ROB	Robots
WPC	WorkPieceCarrier
PAR	Parameters (cross-cutting)
SYS	System
INT	Integration (APIs)
DAT	Data Integrity

ID Format¶

Document: {DocType}-{Context}-{Number} (e.g., URS-MFG-001)
Sub-requirement: {DocType}-{Context}-{Number}.{Sub} (e.g., URS-MFG-001.1)
Standalone: {DocType}-{Number} (e.g., DS-001, RA-001)

Existing ID Patterns (no conflicts)¶

BR-XX, TC-XX, OC-XX, CC-XX, ADR-XXX, QS-XXX, R-X, SCHEMA-XXX (all in arc42/docs)

Relationship to arc42¶

GAMP5 documents reference arc42 content — they do not duplicate it. arc42 remains the source of truth for architecture.

GAMP5 Document	arc42 Section Referenced
All URS	01 - Requirements (BR-01 to BR-08)
All FS	05 - Building Blocks, 06 - Runtime
DS-001	04 - Solution Strategy, 05, 09 - ADRs
DS-002	07 - Deployment
DS-003	08 - Cross-cutting, 09 - ADRs
RA-001	10 - Quality Scenarios, 11 - Risks
PQ-001	10 - Quality Scenarios (performance thresholds)

Maintenance Process¶

See CLAUDE.md section "GAMP5 Documentation Updates" for the development workflow integration.

Action	GAMP5 Update Required
New feature	Add URS sub-requirement, RA risk row, FS specification, RTM entry
Changed feature	Update FS, verify RTM links, re-assess risk
Bug fix	No update needed (unless it reveals a requirements gap)
New parameter type	Add to URS-PAR-001, FS-PAR-001, RTM

Development Lifecycle¶

The development lifecycle connects requirements, implementation, and verification through these artifacts:

Artifact	Location	Purpose
Backlog	`docs/requirements/BACKLOG.md`	Central work item dashboard
Requirement Template	`docs/requirements/Template/REQUIREMENT-TEMPLATE.md`	Template for multi-phase work items
RTM-001	`RTM/RTM-001-traceability-matrix.md`	Single source of truth for requirement status
Lifecycle Rules	`.claude/rules/lifecycle.md`	Enforces workflow during development
Gold Standard	`docs/requirements/Done/SCHEMA/SCHEMA-001-database-alignment.md`	Reference requirement doc (7 phases, complete)

Workflow¶

BACKLOG.md ──► Requirement Doc ──► Implement ──► Test ──► RTM-001 Update
  (index)      (if multi-phase)    (per layer)   (dotnet test)  ("Verified")

See .claude/rules/lifecycle.md for the full mandatory workflow.