Computerized system validation is required by medical device regulations to ensure quality, safety, and effectiveness. Systems that fail to properly validate are at risk of FDA citations, product delays, or worse. However, many companies struggle to implement validation appropriately and efficiently.
What is Covered Under Computerized System Validation?
Validation applies to any computerized systems that:
- Impact medical device functionality
- Collect or analyze product quality data
- Manage device design, production, or distribution
This includes software, databases, cloud platforms, and computer equipment. Their installations, configurations, and operations must be proven reliable.
A Risk-Based Approach to Validation
Trying to exhaustively validate every minor system is impractical and diverts resources from more critical activities.
The FDA allows a risk-based validation approach tied to system criticality. This involves:
- Categorizing systems by potential risks if failures occurred
- Defining validation scope and testing rigor accordingly
- Focusing efforts on most critical systems
Aligning validation activities with risk priorities strikes the right balance between safety, compliance, and resource efficiency.
Meeting GAMP 5 Validation Standards
GAMP 5 is the industry best practice guidance for computerized system validation. Aligning with its methodologies and deliverables helps satisfy regulators that systems are fit for intended use.
Key GAMP 5 System Validation Deliverables
- User Requirements Specifications (URS)
- Traceability Matrix
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (OQ)
- Validation Summary Report
These artifacts demonstrate validation rigor without excessive documentation.
5 Steps to Computerized System Validation
Follow these best practices for efficient, compliant validation:
1. Document User Requirements Specifications
Capture high-level functional and performance requirements for systems requiring validation. This ensures correct system design and configuration.
2. Verify and Test Installation
Perform installation qualification to confirm:
- Hardware/software verification against specifications
- Accurate configuration and integrations
- Security controls and access restrictions
3. Functionally Test Operations
Through operational qualification, test critical system functions against requirements to ensure reliable performance across different use conditions.
4. Validate Performance Reliability
Performance qualification simulates production system usage, data loads, and stress scenarios to demonstrate stability. Periodically retest to ensure operations stay consistent.
5. Maintain Validation Deliverables and Change Controls
Keep URS, qualification evidence, traceability matrices, and summary reports organized for regulatory submissions and internal reference. Manage system changes through formal change control and monitor to ensure ongoing validation state.
Validating Cloud-Based Systems
Validating cloud platforms brings unique challenges, including limited internal system access and dependence on vendor controls.
Best practices for cloud validation include:
- Gaining contractual commitments to meet functional requirements
- Obtaining independent audit certifications where possible
- Performing data security risk assessments
Firms specializing in computer validation for the medical device industry like Greenlight Guru can provide further guidance for cost-effective compliance.
Frequently Asked Questions
1. What regulations cover validation requirements?
Regulations include FDA 21 CFR 820 Quality System Requirements, ISO 13485 Medical Devices Quality Management, and EU MDR 2017/745. Aligning with international standards satisfies most regulators.
2. What systems require validation?
Any computerized systems involved in device product design, manufacturing, testing, distribution, complaint management, or other regulated processes need validation. This excludes basic office software or tools unrelated to product quality.
3. Why follow GAMP 5 methodology for validation?
GAMP 5 represents the medical device industry best practice for efficient, risk-based validation aligned with regulatory expectations. Leveraging its standardized deliverables and testing methods reduces compliance resource demands.
Conclusion
Computerized system validation is a vital process for medical device companies to avoid significant compliance, financial, and patient safety risks. Following standardized GAMP 5 guidelines allows for right-sized validation based on criticality. Partnering with expert providers can further optimize efforts.