---
title: "Validation Master Plan Template"
methodology: "universal"
complexity: "advanced"
owner: "mirichard"
updated: "2026-09-19"
primary_principles: ["quality-by-design", "stewardship"]
secondary_principles: ["systems-thinking"]
principle_rationale: "Coordinates validation scope, responsibilities and lifecycle evidence across systems and processes with controlled change and maintenance."
---

# Validation Master Plan Template

## When to Use

- When a regulated program needs an overall validation strategy and maintenance plan.
- When authorized quality owners must coordinate scope, responsibilities, evidence, and change control.

## When NOT to Use

- As completed validation evidence for a system, process, or site.
- Do not represent author self-checks as independent or authorized approval. See [Self-approval](../../../../../docs/principles/anti-patterns.md#self-approval).

## Pairs Well With

- [Process Validation Master Plan Template](../../../../../domains/delivery/industry-specializations/healthcare-pharmaceutical/validation/process_validation_master_plan_template.md).
- [Computer System Validation Protocol Template](../../../../../domains/delivery/industry-specializations/healthcare-pharmaceutical/regulatory/computer_system_validation_protocol_template.md).

Selection context: Delivery domain; universal methodology; advanced complexity. Match the situations above to project phase, risk, team size, and industry using the [decision-engine context model](../../../../../meta/architecture-research/800-801-context-assessment-model.md).

Reference check: [Current source](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr).


## Applying this template

Treat filled examples, dates, numerical limits, sampling frequencies, and approval outcomes as illustrations. Before execution, replace them with the approved product/site requirements, scientific rationale, method references, responsible reviewer, and acceptance evidence. Record the applicable jurisdiction and current guidance edition; a completed worksheet alone does not demonstrate regulatory compliance.

| Requirement or limit | Applicable source / edition | Product-specific rationale | Approval / date | Execution evidence |
|---|---|---|---|---|
| [Requirement] | [Source] | [Rationale] | [Reviewer / date] | [Record] |


## Document Control & Approvals

| Document Title | Validation Master Plan |
|---------------|------------------------|
| Document ID   | VMP-[Project/System ID]-[Version] |
| Version       | 1.0 |
| Status        | [Draft/In Review/Approved] |
| Date Created  | [YYYY-MM-DD] |
| Last Updated  | 2025-06-20 |

### Document Revision History

| Version | Date | Description of Change | Author | Reviewer |
|---------|------|------------------------|--------|----------|
| 0.1 | [YYYY-MM-DD] | Initial draft | [Name] | [Name] |
| 1.0 | [YYYY-MM-DD] | Released version | [Name] | [Name] |

### Approvals

| Role | Name | Signature | Date |
|------|------|-----------|------|
| Validation Lead | | | |
| Quality Assurance | | | |
| IT/Technical Lead (if applicable) | | | |
| Production/Operations | | | |
| Regulatory Affairs | | | |

## 1. Introduction & Scope

### 1.1 Purpose

This Validation Master Plan (VMP) defines the overall validation strategy, methodology, responsibilities, resources, and planning for the validation activities related to [System/Process/Product Name]. This document establishes a framework to ensure that all GxP regulated systems, processes, and equipment are qualified and validated in compliance with applicable regulations.

### 1.2 Regulatory Requirements

This Validation Master Plan has been developed to meet the following regulatory requirements and industry standards:

- FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures)
- FDA 21 CFR Part 210 & 211 (cGMP for Finished Pharmaceuticals)
- FDA 21 CFR Part 820 (Quality Management System Regulation for medical devices)
- EU GMP Annex 11 (Computerized Systems)
- EU GMP Annex 15 (Qualification and Validation)
- ICH Q8, Q9, Q10 Guidelines
- GAMP 5 (Good Automated Manufacturing Practice)
- [Additional applicable regulations based on product/region]

### 1.3 Facilities/Sites Covered

This Validation Master Plan applies to the following facilities:

| Facility/Site | Location | Scope |
|---------------|----------|-------|
| [Facility Name] | [Address] | [e.g., Manufacturing, QC Testing, Packaging] |
| [Facility Name] | [Address] | [e.g., R&D, Warehousing, Distribution] |

### 1.4 Systems/Processes In Scope

The following systems, processes, and equipment are covered under this Validation Master Plan:

| Item | Type | GAMP Category | GxP Impact | Risk Level |
|------|------|---------------|------------|------------|
| [System/Process/Equipment Name] | [System/Process/Equipment] | [1-5] | [Direct/Indirect] | [High/Medium/Low] |
| [ERP System] | [Computerized System] | [e.g., 4] | [Direct] | [High] |
| [LIMS] | [Computerized System] | [e.g., 4] | [Direct] | [High] |
| [Sterilization Equipment] | [Equipment] | [e.g., 3] | [Direct] | [High] |
| [Environmental Monitoring System] | [Computerized System] | [e.g., 3] | [Direct] | [Medium] |

*GAMP Categories:*
1. Operating System Software
2. Firmware
3. Non-Configured Products
4. Configured Products
5. Custom Applications

### 1.5 Systems/Processes Out of Scope

The following items are explicitly excluded from the scope of this VMP:
- [List of excluded systems, processes, or equipment]
- [Rationale for exclusion]

## 2. Validation Strategy & Approach

### 2.1 Risk-Based Validation Approach

This Validation Master Plan follows a risk-based approach in accordance with ICH Q9 and GAMP 5 principles. The level of validation effort will be commensurate with the level of risk and complexity of each system, process, or equipment:

1. **Risk Assessment**: Formal risk assessments will be conducted to evaluate:
   - Patient safety impact
   - Product quality impact
   - Data integrity impact
   - Regulatory compliance impact
   - Business impact

2. **Risk Control**: Mitigation strategies will be developed based on risk assessment outcomes.

3. **Risk Communication**: Findings and mitigation strategies will be documented and communicated to stakeholders.

4. **Risk Review**: Periodic review of risks will be conducted throughout the validation lifecycle.

#### Example Risk Assessment Matrix

| Risk Level | Impact | Probability | Risk Score | Validation Approach |
|------------|--------|-------------|------------|---------------------|
| High | Severe | Likely | 9 | Full validation with extensive testing |
| Medium | Moderate | Possible | 4-6 | Standard validation with focused testing |
| Low | Minor | Unlikely | 1-3 | Simplified validation with reduced testing |

### 2.2 Validation Lifecycle Model

The validation activities will follow a lifecycle approach consisting of the following phases:

1. **Planning**
   - User Requirements Specification (URS)
   - Validation Planning
   - Risk Assessment

2. **Specification**
   - Functional Specification (FS)
   - Design Specification (DS)
   - Configuration Specification (CS) where applicable

3. **Verification**
   - Installation Qualification (IQ)
   - Operational Qualification (OQ)
   - Performance Qualification (PQ)

4. **Reporting**
   - Validation Summary Report
   - Traceability Matrix

5. **Maintenance**
   - Periodic Review
   - Change Management
   - Revalidation Assessment

### 2.3 Documentation Requirements

The following validation documentation will be required based on the risk assessment results:

#### High-Risk Systems/Processes
- Validation Plan
- Risk Assessment
- URS, FS, DS
- IQ, OQ, PQ Protocols and Reports
- Traceability Matrix
- Validation Summary Report
- Standard Operating Procedures (SOPs)
- Training Records

#### Medium-Risk Systems/Processes
- Validation Plan
- Risk Assessment
- URS, FS
- IQ, OQ Protocols and Reports
- Validation Summary Report
- SOPs
- Training Records

#### Low-Risk Systems/Processes
- Validation Plan
- Risk Assessment
- URS
- Verification Testing
- Validation Summary Report

### 2.4 Change Control Integration

All changes to validated systems, processes, or equipment will be managed through a formal Change Control process:

1. **Change Request**: Documentation of proposed change and justification
2. **Impact Assessment**: Evaluation of GxP impact and revalidation requirements
3. **Change Approval**: Formal approval by relevant stakeholders
4. **Implementation**: Execution of approved change
5. **Verification**: Testing and documentation of changes
6. **Closure**: Final approval and documentation

## 3. Roles & Responsibilities

### 3.1 Validation Team Structure

The following organizational structure will be established for validation activities:

```
[Validation Governance Committee]
          |
    [Validation Lead]
          |
-----------------------
|         |           |
[SMEs] [QA Team] [Technical Team]
```

### 3.2 Key Stakeholders

| Role | Responsibilities |
|------|------------------|
| **Validation Governance Committee** | - Provide strategic oversight<br>- Approve key validation documents<br>- Resolve escalated issues |
| **Validation Lead** | - Develop validation strategy and plans<br>- Coordinate validation activities<br>- Ensure compliance with regulations<br>- Report validation status to management |
| **Quality Assurance** | - Review and approve validation documentation<br>- Conduct QA audits of validation activities<br>- Ensure compliance with quality standards |
| **Subject Matter Experts (SMEs)** | - Provide domain expertise<br>- Contribute to requirements specification<br>- Support test execution and review |
| **Technical Team** | - Perform technical implementation<br>- Support validation testing<br>- Troubleshoot technical issues |
| **System Owner** | - Define system requirements<br>- Accept validated system<br>- Maintain system in validated state |
| **Regulatory Affairs** | - Provide regulatory guidance<br>- Review for regulatory compliance |

### 3.3 Training Requirements

All personnel involved in validation activities must be appropriately qualified through:

1. **Basic Training**:
   - GxP regulations
   - Validation principles
   - Data integrity requirements
   - Documentation practices

2. **Role-Specific Training**:
   - Validation methodology
   - Risk assessment techniques
   - Protocol execution
   - Testing methods

3. **System-Specific Training**:
   - System functionality
   - System administration
   - Troubleshooting

Training records must be maintained for all personnel involved in validation activities.

## 4. Validation Program Elements

### 4.1 Equipment Qualification (IQ/OQ/PQ)

#### 4.1.1 Installation Qualification (IQ)
- Verification of proper installation according to specifications
- Documentation of equipment/system specifications
- Verification of utility connections
- Installation of accessories and auxiliary systems
- Software installation verification
- Documentation of system configuration
- Verification of calibration status and records
- Confirmation of vendor documentation completeness

#### 4.1.2 Operational Qualification (OQ)
- Verification of system functionality against specifications
- Testing of control parameters
- Testing of alarms, alerts, and security features
- Verification of user interfaces
- Challenging system to upper and lower operating limits
- Verification of data collection and reporting capabilities
- Negative testing (error handling and system recovery)
- Testing of all critical functions and features

#### 4.1.3 Performance Qualification (PQ)
- Verification of system performance under actual operating conditions
- Testing with actual products and processes
- Process reproducibility testing
- Long-term performance evaluation
- Integration with other systems
- Stress testing under maximum load conditions
- Recovery testing after power or system failures
- End-to-end process verification

### 4.2 Process Validation

Process validation will follow a three-stage approach:

#### 4.2.1 Stage 1: Process Design
- Process development activities
- Identification of critical process parameters (CPPs)
- Identification of critical quality attributes (CQAs)
- Design space determination
- Risk assessment

#### 4.2.2 Stage 2: Process Qualification
- Equipment qualification
- Process performance qualification (PPQ) runs
- Statistical evaluation of process data
- Establishment of control strategy

#### 4.2.3 Stage 3: Continued Process Verification
- Ongoing monitoring of process performance
- Statistical process control
- Periodic review
- Continuous improvement

### 4.3 Computer System Validation

Computer system validation will follow GAMP 5 guidelines with activities appropriate to the system category:

#### 4.3.1 Infrastructure Qualification
- Network qualification
- Server qualification
- Workstation qualification
- Virtualization platform qualification (if applicable)
- Cloud infrastructure qualification (if applicable)
- Cybersecurity controls verification
- Disaster recovery infrastructure qualification

#### 4.3.2 Application Validation
- Specification development
- Configuration verification
- Functional testing
- Data integrity controls verification
- Security testing
- Interface testing
- Backup and recovery testing
- Audit trail verification
- Electronic signature validation (if applicable)
- User access control testing
- Data lifecycle management testing

#### 4.3.3 Data Migration Validation (if applicable)
- Data mapping verification
- Migration testing
- Data reconciliation
- Data integrity verification
- Historical data verification
- Exception handling during migration
- Rollback procedure verification
- Post-migration system performance verification

### 4.4 Cleaning Validation

Cleaning validation activities will include:

- Cleaning process development
- Worst-case product identification
- Selection of cleaning agents
- Development of analytical methods
- Establishment of acceptance criteria
- Sampling plan development
- Recovery studies
- Cleaning validation protocols (at least 3 consecutive successful runs)
- Ongoing monitoring

### 4.5 Method Validation

Analytical method validation will include:

- Method development
- Validation protocol development
- Validation of method parameters:
  - Accuracy
  - Precision
  - Specificity
  - Limit of detection
  - Limit of quantitation
  - Linearity
  - Range
  - Robustness
- Transfer of methods (if applicable)
- Ongoing method verification

### 4.6 Facility & Utility Validation

Facility and utility validation will include:

- Design qualification
- Component qualification
- Installation qualification
- Operational qualification
- Performance qualification
- Mapping studies (temperature, humidity, differential pressure)
- Challenge testing
- Ongoing monitoring and periodic requalification

## 5. Documentation & Deliverables

### 5.1 Required Protocols

The following protocol types will be used in validation activities:

| Protocol Type | Purpose | Required For |
|--------------|---------|--------------|
| Validation Plan | Define validation approach and scope | All systems/processes |
| Risk Assessment Protocol | Document risk assessment methodology | All systems/processes |
| IQ Protocol | Verify proper installation | Equipment, systems |
| OQ Protocol | Verify proper operation | Equipment, systems |
| PQ Protocol | Verify performance under actual conditions | Equipment, systems, processes |
| Process Validation Protocol | Validate manufacturing processes | Critical processes |
| Cleaning Validation Protocol | Validate cleaning procedures | Product contact equipment |
| Method Validation Protocol | Validate analytical methods | Test methods |
| Computer System Validation Protocol | Validate computer systems | GxP computerized systems |

### 5.2 Test Scripts

Test scripts will be developed according to the following principles:

- Each test script will have a unique identifier
- Prerequisites will be clearly defined
- Step-by-step test procedures will be documented
- Expected results will be predefined
- Actual results will be recorded
- Pass/Fail criteria will be established
- Deviations will be documented and investigated

Example test script format:

```
Test ID: [Unique Identifier]
Test Title: [Brief Description]
Objective: [Purpose of Test]
Prerequisites: [Required Conditions]
Test Steps:
1. [Action 1]
   Expected Result: [Expected Outcome]
   Actual Result: [To be completed during testing]
   Pass/Fail: [To be completed during testing]
2. [Action 2]
   Expected Result: [Expected Outcome]
   Actual Result: [To be completed during testing]
   Pass/Fail: [To be completed during testing]
Tester: ____________ Date: __________
Reviewer: ____________ Date: __________
```

### 5.3 Reports

The following reports will be generated during validation activities:

| Report Type | Purpose | Timing |
|-------------|---------|--------|
| Validation Plan | Document validation strategy | Before validation activities |
| Risk Assessment Report | Document risk assessment results | Before protocol execution |
| IQ Report | Document installation qualification results | After IQ completion |
| OQ Report | Document operational qualification results | After OQ completion |
| PQ Report | Document performance qualification results | After PQ completion |
| Validation Summary Report | Summarize all validation activities | After completion of all validation |
| Periodic Review Report | Document periodic review results | According to review schedule |

### 5.4 Standard Operating Procedures

The following SOPs will be developed or updated to support validated systems and processes:

- System Operation
- System Administration
- User Management
- Backup and Recovery
- Data Management
- Change Control
- Incident Management
- Periodic Review
- Training
- Documentation Management

## 6. Validation Maintenance

### 6.1 Periodic Review Requirements

Validated systems and processes will undergo periodic review according to the following schedule:

| Risk Level | Review Frequency | Review Scope |
|------------|------------------|--------------|
| Critical | Bi-annual | Complete system review including all documentation, testing of critical functionality, comprehensive audit trail review |
| High | Annual | Comprehensive review of system, documentation, change history, deviations, incidents |
| Medium | Biennial | Review of critical aspects, change history, deviations |
| Low | Triennial | Basic review of system status and changes |

The periodic review will assess:
- Continued compliance with regulations
- Cumulative effect of changes
- Incident and deviation trends
- Training status
- SOP currency
- Need for revalidation

### 6.2 Revalidation Criteria

Revalidation will be triggered by:

1. **Significant Changes**:
   - Major software upgrades
   - Hardware replacements
   - Process modifications
   - Changes to critical components
   - Relocation of equipment
   - Changes in critical vendors or suppliers
   - Significant organizational changes affecting system ownership
   - Changes in regulatory requirements impacting validation status

2. **Performance Issues**:
   - Recurring deviations
   - Out-of-specification results
   - System failures
   - Quality issues

3. **Regulatory Triggers**:
   - New regulatory requirements
   - Regulatory inspection findings
   - Industry standard changes

4. **Time-Based Triggers**:
   - According to risk-based schedule
   - After extended period of non-use

### 6.3 Change Control Process

All changes to validated systems and processes will follow this process:

1. **Change Request**:
   - Detailed description of proposed change
   - Justification for change
   - Initial impact assessment

2. **Evaluation**:
   - Detailed impact assessment
   - Risk assessment
   - Determination of validation requirements
   - Development of test strategy

3. **Approval**:
   - Review by key stakeholders
   - Approval by authorized personnel
   - Documentation of approval decision

4. **Implementation**:
   - Implementation planning
   - Execution of change
   - Required testing
   - Documentation updates

5. **Verification**:
   - Verification of changes
   - Execution of required validation activities
   - Documentation of results

6. **Closure**:
   - Final review
   - Formal closure
   - Update of validation status

### 6.4 Deviation Management

Deviations from validated processes or systems will be managed as follows:

1. **Identification and Documentation**:
   - Description of deviation
   - Initial impact assessment
   - Immediate actions taken

2. **Investigation**:
   - Root cause analysis
   - Extent of impact assessment
   - GxP impact assessment

3. **Corrective and Preventive Actions (CAPA)**:
   - Development of CAPA plan
   - Implementation of corrective actions
   - Implementation of preventive actions

4. **Effectiveness Check**:
   - Verification of CAPA effectiveness
   - Documentation of results

5. **Closure**:
   - Final review
   - Formal closure
   - Update of validation status if required

## 7. Quality Oversight

### 7.1 Quality Assurance Role

Quality Assurance will provide oversight of validation activities through:

1. **Document Review and Approval**:
   - Review of validation documents for compliance
   - Approval of key validation deliverables
   - Verification of document completeness
   - Ensuring traceability across validation documentation
   - Verification of compliance with regulatory requirements

2. **Audit of Validation Activities**:
   - Planned audits of validation execution
   - Verification of protocol execution
   - Review of documentation practices
   - Witnessing of critical validation activities
   - Review of test data integrity
   - Assessment of validation team competency

3. **Quality Metrics**:
   - Tracking of validation schedule adherence
   - Monitoring of deviation and CAPA status
   - Assessment of validation effectiveness
   - Measurement of validation resource utilization
   - Tracking of defect discovery rates during validation
   - Monitoring time to close validation issues
   - Reporting validation status to senior management

### 7.2 Review & Approval Process

The following review and approval process will be followed for validation documentation:

1. **Document Preparation**:
   - Preparation by assigned author
   - Internal technical review

2. **Quality Review**:
   - Review by Quality Assurance
   - Verification of compliance with standards
   - Documentation of review comments

3. **Stakeholder Review**:
   - Review by relevant stakeholders
   - Documentation of review comments
   - Resolution of comments

4. **Final Approval**:
   - Approval by authorized personnel
   - Documentation of approval
   - Controlled distribution

### 7.3 Audit Requirements

Validation activities will be subject to the following audits:

1. **Internal Audits**:
   - Scheduled validation process audits
   - For-cause audits as needed
   - Pre-approval audits before major regulatory submissions

2. **Supplier Audits**:
   - Audits of critical suppliers
   - Assessment of supplier validation practices
   - Verification of supplier qualifications

3. **Regulatory Inspections**:
   - Preparation for regulatory inspections
   - Support during inspections
   - Management of inspection findings

## 8. Supporting Systems & Tools

### 8.1 Document Management

Validation documentation will be managed through:

- Electronic document management system for controlled documents
- Version control mechanisms
- Review and approval workflows
- Secure storage and backup
- Retention according to regulatory requirements
- Controlled access based on roles
- Audit trail of document activities

### 8.2 Training Management

Training for validation activities will be managed through:

- Learning management system
- Role-based training requirements
- Training effectiveness assessment
- Documentation of training completion
- Periodic refresher training
- Training status tracking

### 8.3 Change Control System

Changes will be managed through:

- Electronic change control system
- Configurable workflows
- Risk assessment integration
- Impact assessment tools
- Approval routing
- Implementation tracking
- Change history reporting

### 8.4 CAPA System

Deviations and CAPAs will be managed through:

- Electronic CAPA management system
- Integration with deviation management
- Root cause analysis tools
- CAPA effectiveness tracking
- Trend analysis capabilities
- Reporting functions

## 9. Appendices

### 9.1 Risk Assessment Templates

#### Example: Risk Assessment Form

```
Risk Assessment ID: [Unique Identifier]
System/Process: [Name]
Date: [YYYY-MM-DD]
Participants: [Names and Roles]

Risk Items:
1. [Risk Description]
   - Potential Impact: [High/Medium/Low]
   - Probability: [High/Medium/Low]
   - Risk Score: [Calculation]
   - Mitigation Strategy: [Description]
   - Residual Risk: [High/Medium/Low]
   - Owner: [Name]

2. [Risk Description]
   - Potential Impact: [High/Medium/Low]
   - Probability: [High/Medium/Low]
   - Risk Score: [Calculation]
   - Mitigation Strategy: [Description]
   - Residual Risk: [High/Medium/Low]
   - Owner: [Name]

Overall Risk Assessment: [High/Medium/Low]
Recommendations: [Description]
Approvals: [Names, Signatures, Dates]
```

### 9.2 Protocol Templates

#### Example: IQ Protocol Template

```
Installation Qualification Protocol
Protocol ID: [Unique Identifier]
System/Equipment: [Name]
Version: [Number]
Status: [Draft/Approved/Executed]

1. Purpose and Scope
2. References
3. Responsibilities
4. Prerequisites
5. Equipment and Materials
6. Installation Verification Tests:
   6.1 Hardware Verification
   6.2 Software Installation Verification
   6.3 Configuration Verification
   6.4 Utilities Verification
7. Acceptance Criteria
8. Deviations
9. Conclusion
10. Approvals
```

#### Example: OQ Protocol Template

```
Operational Qualification Protocol
Protocol ID: [Unique Identifier]
System/Equipment: [Name]
Version: [Number]
Status: [Draft/Approved/Executed]

1. Purpose and Scope
2. References
3. Responsibilities
4. Prerequisites
5. Equipment and Materials
6. Operational Tests:
   6.1 Functional Testing
   6.2 Security Testing
   6.3 Alarm Testing
   6.4 Boundary Testing
7. Acceptance Criteria
8. Deviations
9. Conclusion
10. Approvals
```

### 9.3 Report Templates

#### Example: Validation Summary Report Template

```
Validation Summary Report
Report ID: [Unique Identifier]
System/Process: [Name]
Version: [Number]
Date: [YYYY-MM-DD]

1. Executive Summary
2. Validation Scope
3. Validation Approach
4. Validation Activities Performed
5. Summary of Results:
   5.1 Risk Assessment
   5.2 IQ Results
   5.3 OQ Results
   5.4 PQ Results
6. Deviations and Resolutions
7. Traceability Matrix
8. Conclusion and Validation Statement
9. Approvals
```

### 9.4 Checklist Templates

#### Example: Validation Readiness Checklist

```
Validation Readiness Checklist
System/Process: [Name]
Date: [YYYY-MM-DD]
Completed By: [Name]

1. Planning Documents:
   □ Validation Plan approved
   □ Risk Assessment completed
   □ Requirements documented

2. Resources:
   □ Validation team identified
   □ Training completed
   □ Schedule established

3. Documentation:
   □ Document templates available
   □ Document control process in place
   □ Traceability matrix prepared

4. Testing:
   □ Test environments ready
   □ Test data prepared
   □ Testing tools available

5. Quality Oversight:
   □ QA involvement planned
   □ Review and approval process defined
   □ Audit schedule established

Overall Readiness: [Ready/Not Ready]
Comments: [Description]
```

## 10. References

1. FDA. 21 CFR Part 11, Electronic Records; Electronic Signatures.
2. FDA. 21 CFR Part 210 & 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.
3. FDA. 21 CFR Part 820, Quality System Regulation.
4. EudraLex. Volume 4, EU Guidelines for Good Manufacturing Practice, Annex 11, Computerized Systems.
5. EudraLex. Volume 4, EU Guidelines for Good Manufacturing Practice, Annex 15, Qualification and Validation.
6. International Conference on Harmonization (ICH). Q8 Pharmaceutical Development.
7. International Conference on Harmonization (ICH). Q9 Quality Risk Management.
8. International Conference on Harmonization (ICH). Q10 Pharmaceutical Quality System.
9. ISPE. GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems.
10. PIC/S. PI 011-3 Good Practices for Computerized Systems in Regulated "GXP" Environments.
11. FDA. Data Integrity and Compliance with Drug CGMP: Questions and Answers, Guidance for Industry.
12. ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes.
13. ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
14. EU MDR 2017/745 Medical Device Regulation.
15. ISO 14971:2019 Medical devices — Application of risk management to medical devices.