Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inventory, criticality classification (GxP-critical, GxP-supporting, non-GxP), GAMP 5 category assignment, regulatory requirements traceability, and governance structure definition. Use when establishing a new regulated facility, formalising compliance across multiple systems, addressing a regulatory gap analysis, harmonising compliance after mergers or reorganisations, or preparing a site master file that references computerized systems.
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Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inventory, criticality classification (GxP-critical, GxP-supporting, non-GxP), GAMP 5 category assignment, regulatory requirements traceability, and governance structure definition. Use when establishing a new regulated facility, formalising compliance across multiple systems, addressing a regulatory gap analysis, harmonising compliance after mergers or reorganisations, or preparing a site master file that references computerized systems.
Optional: Existing validation master plan or quality manual
Optional: Previous audit findings or regulatory inspection observations
Optional: Organisational chart with quality and IT reporting lines
Steps
Step 1: Build System Inventory
Create comprehensive inventory of all computerized systems:
# System Inventory## Document ID: SI-[SITE]-[YYYY]-[NNN]
| ID | System Name | Version | Vendor | Purpose | Department | Data Types | Users |
|----|-------------|---------|--------|---------|------------|------------|-------|
| SYS-001 | LabWare LIMS | 8.1 | LabWare Inc. | Sample management and testing | QC | Test results, COA | 45 |
| SYS-002 | SAP ERP | S/4HANA | SAP SE | Batch release and inventory | Production | Batch records, BOM | 120 |
| SYS-003 | Custom R/Shiny | 2.1.0 | Internal | Statistical analysis | Biostatistics | Clinical data | 8 |
| SYS-004 | Windows Server | 2022 | Microsoft | File server | IT | Documents | 200 |
Got: Every system that creates, modifies, stores, retrieves, or transmits GxP-relevant data is listed.
If fail: If system owners cannot provide complete information, document gap and schedule discovery workshop. Missing systems are critical compliance risk.
Step 2: Classify System Criticality
Assign each system criticality tier:
# System Criticality Classification## Document ID: SCC-[SITE]-[YYYY]-[NNN]
| Tier | Definition | Validation Required | Examples |
|------|-----------|-------------------|----------|
| | Directly impacts product quality, patient safety, or data integrity. Generates or processes GxP records. | Full CSV per GAMP 5 | LIMS, ERP (batch), CDMS, MES |
| | Supports GxP processes but does not directly generate GxP records. Failure has indirect impact. | Risk-based qualification | Email, document management, scheduling |
| | No impact on product quality, safety, or data integrity. | IT standard controls only | HR systems, cafeteria, general web |
| System ID | System | Tier | Rationale |
|-----------|--------|------|-----------|
| SYS-001 | LabWare LIMS | GxP-Critical | Generates test results used for batch release |
| SYS-002 | SAP ERP | GxP-Critical | Manages batch records and material traceability |
| SYS-003 | R/Shiny App | GxP-Critical | Performs statistical analysis for regulatory submissions |
| SYS-004 | Windows Server | GxP-Supporting | Stores controlled documents but does not generate GxP data |
### Classification Criteria
**GxP-Critical**
**GxP-Supporting**
**Non-GxP**
### System Classification Matrix
Got: Every system has tier assignment with documented rationale.
If fail: If system's criticality disputed, escalate to quality council. When in doubt, classify one tier higher and reassess after formal risk assessment.
Step 3: Assign GAMP 5 Software Categories
For each GxP-Critical and GxP-Supporting system, assign GAMP 5 category:
# GAMP 5 Category Assignment
| System ID | System | GAMP Category | Rationale | Validation Effort |
|-----------|--------|---------------|-----------|-------------------|
| SYS-001 | LabWare LIMS | 4 — Configured Product | COTS with extensive workflow configuration | Medium-High |
| SYS-002 | SAP ERP | 4 — Configured Product | COTS with custom transactions | Medium-High |
| SYS-003 | R/Shiny App | 5 — Custom Application | Internally developed | High — Full lifecycle |
| SYS-004 | Windows Server | 1 — Infrastructure | Operating system, no custom configuration | Low — Verify installation |
Category 4: Configured product — verify all configurations
Category 5: Custom application — full lifecycle validation
Got: Category assignment aligns with how system used, not just what it is.
If fail: If system spans categories (e.g., COTS with custom add-ons), classify custom portions as Category 5 and base as Category 4.
Got: Every applicable regulatory clause maps to at least one system. Every GxP-Critical system maps to relevant regulatory clauses.
If fail: Unmapped clauses represent compliance gaps. Create remediation plan with timelines for each gap.
Step 5: Define Validation Strategy Per System
Based on criticality, category, regulatory mapping:
Got: Validation effort proportional to risk — Category 5 GxP-Critical systems get full lifecycle. Category 1 infrastructure gets streamlined IQ.
If fail: If stakeholders push for reduced validation of critical systems, document risk acceptance with QA sign-off.
Step 6: Design Governance Structure
Define organisational framework for sustaining compliance:
# Compliance Governance Structure## Roles and Responsibilities
| Role | Responsibility | Authority |
|------|---------------|-----------|
| Quality Director | Overall compliance accountability | Approve validation strategies, accept risks |
| System Owner | Day-to-day system compliance | Approve changes, ensure validated state |
| Validation Lead | Plan and coordinate validation activities | Define validation scope and approach |
| IT Operations | Technical infrastructure and security | Implement technical controls |
| QA Reviewer | Independent review of validation deliverables | Accept or reject validation evidence |
## Governance Committees
| Committee | Frequency | Purpose | Members |
|-----------|-----------|---------|---------|
| Change Control Board | Weekly | Review and approve system changes | System owners, QA, IT, validation |
| Periodic Review Committee | Quarterly | Review system compliance status | Quality director, system owners, QA |
| Audit Programme Committee | Annual | Plan internal audit schedule | Quality director, lead auditor, QA |
## Escalation Matrix
| Issue | First Escalation | Second Escalation | Timeline |
|-------|-----------------|-------------------|----------|
| Critical audit finding | System Owner → QA Director | QA Director → Site Director | 24 hours |
| Validated state breach | Validation Lead → System Owner | System Owner → Quality Director | 48 hours |
| Data integrity incident | System Owner → QA Director | QA Director → Regulatory Affairs | 24 hours |
Got: Clear accountability for every compliance activity with no orphaned responsibilities.
If fail: If roles overlap or unassigned, convene RACI workshop to resolve. Ambiguous ownership is recurring regulatory citation.
Step 7: Compile Compliance Architecture Document
Assemble all components into master document:
# Compliance Architecture## Document ID: CA-[SITE]-[YYYY]-[NNN]## Version: 1.0### 1. Purpose and Scope
[Organisation, site, product scope, regulatory scope]
### 2. System Inventory
[From Step 1]
### 3. Criticality Classification
[From Step 2]
### 4. GAMP 5 Category Assignments
[From Step 3]
### 5. Regulatory Requirements Traceability
[From Step 4]
### 6. Validation Strategy
[From Step 5]
### 7. Governance Structure
[From Step 6]
### 8. Periodic Review Schedule- System inventory refresh: Annual
- Criticality re-assessment: When new systems added or regulations change
- Regulatory mapping update: When new guidance issued
- Governance review: Annual or after organisational change
### 9. Approval
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Quality Director | | | |
| IT Director | | | |
| Regulatory Affairs | | | |
Got: Single document serving as compliance blueprint for entire regulated environment.
If fail: If document exceeds practical size, create master document with references to subsidiary documents per system or domain.
Checks
System inventory includes every system handling GxP data
Every system has criticality tier with documented rationale
GAMP 5 categories assigned to all GxP-Critical and GxP-Supporting systems
Regulatory requirements traceability matrix covers all applicable clauses
Every GxP-Critical system has defined validation strategy
Compliance architecture document approved by quality and IT leadership
Pitfalls
Incomplete inventory: Missing systems invisible to compliance. Use network scans, software asset management tools, department interviews — not just asking IT.
Binary thinking: Systems not simply "GxP" or "not GxP." Three-tier model (Critical, Supporting, Non-GxP) avoids both over-validation and under-validation.
Category confusion: GAMP 5 category describes what software IS, but validation effort should reflect how USED. Category 4 system used for batch release needs more testing than Category 4 system used for scheduling.
Static architecture: Compliance architecture is living document. New systems, regulatory changes, audit findings all require updates.
Governance without teeth: Committees existing on paper but never meeting provide no compliance value. Define meeting cadence and quorum requirements.
See Also
perform-csv-assessment — execute validation strategy defined here for individual systems
manage-change-control — operationalise change control process defined in governance
implement-electronic-signatures — implement e-signature controls mapped in regulatory matrix
prepare-inspection-readiness — use this architecture as foundation for inspection preparation
conduct-gxp-audit — audit against compliance architecture as baseline
