Perform CSV Assessment

Conduct a Computer Systems Validation assessment using GAMP 5 risk-based methodology for regulated environments.

When to Use

• A new computerized system is being introduced in a GxP environment
• An existing validated system is undergoing significant change
• Periodic revalidation is required
• Regulatory inspection preparation demands a validation gap analysis

Inputs

• Required: System description (name, purpose, vendor, version)
• Required: Intended use statement and regulatory context (GxP scope)
• Required: GAMP 5 software category (1–5)
• Optional: Existing user requirements specification (URS)
• Optional: Vendor documentation (design specs, release notes, SOPs)
• Optional: Previous validation documentation

Procedure

Step 1: Determine GAMP 5 Software Category

Classify the system:

Category	Type	Example	Validation Effort
1	Infrastructure software	OS, firmware	Low — verify installation
3	Non-configured product	COTS as-is	Low-Medium — verify functionality
4	Configured product	LIMS with config	Medium-High — verify configuration
5	Custom application	Bespoke R/Shiny app	High — full lifecycle validation

Expected: Category clearly assigned with rationale documented. On failure: If category is ambiguous, default to the higher category and document the rationale.

Step 2: Write User Requirements Specification (URS)

Create a URS document with numbered requirements:

# User Requirements Specification
## System: [System Name] v[Version]
## Document ID: URS-[SYS]-[NNN]

### 1. Purpose
[Intended use statement]

### 2. Functional Requirements
| ID | Requirement | Priority | Source |
|----|-------------|----------|--------|
| URS-001 | System shall calculate BMI from height and weight inputs | Must | Regulatory SOP-xxx |
| URS-002 | System shall generate audit trail entries for all data changes | Must | 21 CFR 11.10(e) |
| URS-003 | System shall export results in PDF format | Should | User request |

### 3. Non-Functional Requirements
| ID | Requirement | Priority | Source |
|----|-------------|----------|--------|
| URS-010 | System shall respond within 3 seconds for standard queries | Should | Usability |
| URS-011 | System shall restrict access via role-based authentication | Must | 21 CFR 11.10(d) |

### 4. Data Integrity Requirements
[ALCOA+ requirements: Attributable, Legible, Contemporaneous, Original, Accurate]

### 5. Regulatory Requirements
[Specific 21 CFR Part 11, EU Annex 11, or other applicable requirements]

Expected: All requirements have unique IDs, priorities, and traceability to source. On failure: Flag requirements without clear source or priority for stakeholder review.

Step 3: Perform Risk Assessment

Apply GAMP 5 risk-based approach using a Failure Mode and Effects Analysis (FMEA):

# Risk Assessment
## Document ID: RA-[SYS]-[NNN]

| Req ID | Failure Mode | Severity (1-5) | Probability (1-5) | Detectability (1-5) | RPN | Risk Level | Mitigation |
|--------|-------------|----------------|-------------------|---------------------|-----|------------|------------|
| URS-001 | Incorrect BMI calculation | 4 | 2 | 1 | 8 | Low | OQ test case |
| URS-002 | Audit trail entries missing | 5 | 3 | 3 | 45 | High | IQ + OQ + monitoring |
| URS-011 | Unauthorized access | 5 | 2 | 2 | 20 | Medium | OQ test + periodic review |

Risk Priority Number (RPN) = Severity x Probability x Detectability.

RPN Range	Risk Level	Testing Requirement
1–12	Low	Basic verification
13–36	Medium	Documented test case
37+	High	Full IQ/OQ/PQ with retest

Expected: Every URS requirement has a corresponding risk assessment row. On failure: Escalate unassessed requirements to the validation lead before proceeding.

Step 4: Define Validation Strategy (Validation Plan)

# Validation Plan
## Document ID: VP-[SYS]-[NNN]

### Scope
- System: [Name] v[Version]
- GAMP Category: [N]
- Validation approach: [Prospective / Retrospective / Concurrent]

### Qualification Stages
| Stage | Scope | Applies? | Rationale |
|-------|-------|----------|-----------|
| IQ | Installation correctness | Yes | Verify installation, dependencies, configuration |
| OQ | Operational requirements | Yes | Verify functional requirements from URS |
| PQ | Performance under real conditions | [Yes/No] | [Rationale] |

### Roles and Responsibilities
| Role | Name | Responsibility |
|------|------|---------------|
| Validation Lead | [Name] | Plan, coordinate, approve |
| Tester | [Name] | Execute test scripts |
| System Owner | [Name] | Approve for production use |
| QA | [Name] | Review and sign-off |

### Acceptance Criteria
- All critical test cases pass
- No unresolved critical or major deviations
- Traceability matrix complete

Expected: Validation plan approved by all stakeholders before test execution. On failure: Do not proceed to test execution without an approved validation plan.

Step 5: Create Test Protocols (IQ/OQ/PQ)

Write test scripts for each qualification stage:

# Operational Qualification Protocol
## Test Case: TC-OQ-001
## Traces to: URS-001

**Objective:** Verify BMI calculation accuracy

**Prerequisites:**
- System installed per IQ protocol
- Test data set prepared

**Test Steps:**
| Step | Action | Expected Result | Actual Result | Pass/Fail |
|------|--------|-----------------|---------------|-----------|
| 1 | Enter height=180cm, weight=75kg | BMI displayed as 23.15 | | |
| 2 | Enter height=160cm, weight=90kg | BMI displayed as 35.16 | | |
| 3 | Enter height=0, weight=75kg | Error message displayed | | |

**Tester:** _________ Date: _________
**Reviewer:** _________ Date: _________

Expected: Every medium- and high-risk requirement has at least one test case. On failure: Add missing test cases before execution begins.

Step 6: Build Traceability Matrix

Create a Requirements Traceability Matrix (RTM) linking every requirement through risk assessment to test cases:

# Traceability Matrix
## Document ID: TM-[SYS]-[NNN]

| URS ID | Requirement | Risk Level | Test Case(s) | Test Result | Status |
|--------|-------------|------------|--------------|-------------|--------|
| URS-001 | BMI calculation | Low | TC-OQ-001 | Pass | Verified |
| URS-002 | Audit trail | High | TC-IQ-003, TC-OQ-005 | Pass | Verified |
| URS-003 | PDF export | Low | TC-OQ-008 | Pass | Verified |
| URS-011 | Role-based access | Medium | TC-OQ-010, TC-OQ-011 | Pass | Verified |

Expected: 100% of URS requirements appear in the traceability matrix with linked test results. On failure: Any requirement without a linked test result is flagged as a validation gap.

Step 7: Write Validation Summary Report

# Validation Summary Report
## Document ID: VSR-[SYS]-[NNN]

### 1. Executive Summary
[System name] v[version] has been validated in accordance with [VP document ID].

### 2. Validation Activities Performed
| Activity | Document ID | Status |
|----------|-------------|--------|
| User Requirements | URS-SYS-001 | Approved |
| Risk Assessment | RA-SYS-001 | Approved |
| Validation Plan | VP-SYS-001 | Approved |
| IQ Protocol/Report | IQ-SYS-001 | Executed — Pass |
| OQ Protocol/Report | OQ-SYS-001 | Executed — Pass |
| Traceability Matrix | TM-SYS-001 | Complete |

### 3. Deviations
| Dev ID | Description | Impact | Resolution |
|--------|-------------|--------|------------|
| DEV-001 | [Description] | [Impact assessment] | [Resolution and rationale] |

### 4. Conclusion
The system meets all user requirements as documented in [URS ID]. The validation is considered [Successful / Successful with conditions].

### 5. Approval
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Validation Lead | | | |
| System Owner | | | |
| Quality Assurance | | | |

Expected: Report references all validation deliverables with clear pass/fail conclusion. On failure: If deviations are unresolved, the report must state "conditional" status with CAPA references.

Validation

• GAMP 5 category assigned with documented rationale
• URS has numbered requirements with priorities and traceability to source
• Risk assessment covers every URS requirement
• Validation plan approved before test execution
• Test protocols have prerequisite, step, expected result, and signature fields
• Traceability matrix links every requirement to risk and test results
• Validation summary report documents all activities, deviations, and conclusion
• All documents have unique document IDs and version control

Common Pitfalls

• Over-validation: Applying Category 5 effort to Category 3 software wastes resources. Match effort to risk.
• Missing traceability: Requirements that don't trace through to test cases are invisible gaps.
• Testing without a plan: Executing tests before the validation plan is approved invalidates results.
• Ignoring non-functional requirements: Security, performance, and data integrity requirements are often overlooked.
• Static validation: Treating validation as a one-time event. Changes require re-assessment.

Related Skills

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  — project structure for validated R environments

• write-validation-documentation

  — IQ/OQ/PQ protocol and report writing

• implement-audit-trail

  — audit trail implementation for electronic records

• validate-statistical-output

  — statistical output verification methodology

• conduct-gxp-audit

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