Understanding GAMP 5
GAMP 5 (Good Automated Manufacturing Practice Guide, Version 5) was published by ISPE in 2008 and remains the industry standard for computerized system validation in pharmaceutical and related regulated industries. The guide provides a risk-based approach that scales validation effort to system complexity and impact.
Risk-Based Validation
GAMP 5’s fundamental principle is that validation effort should be proportionate to risk:
- Higher risk systems require more extensive validation
- Lower risk systems can use streamlined approaches
- Risk assessment guides validation strategy
Software Categories
The guide defines categories that help determine validation requirements:
| Category | Description | Validation Approach |
|---|---|---|
| 1 | Infrastructure Software | Verification of installation |
| 3 | Non-Configured Products | Configuration documentation |
| 4 | Configured Products | Configuration and testing |
| 5 | Custom Applications | Full SDLC documentation |
ATEK as Category 4
ATEK’s environmental monitoring platform is a Category 4 Configured Product:
- Commercial off-the-shelf software
- Configured to customer requirements
- No custom code development
- Validation through configuration documentation and testing
How ATEK Supports GAMP 5 Compliance
ATEK provides the documentation and features needed for validated environments.
Validation Documentation
Our validation packages include:
- User Requirements Specification (URS): Template for documenting your requirements
- Installation Qualification (IQ): Verify correct installation
- Operational Qualification (OQ): Verify system operates as specified
- Performance Qualification (PQ): Verify system performs in your environment
- Traceability Matrix: Link requirements to testing
Data Integrity
ALCOA+ principles are embedded in our platform:
- Attributable: All data linked to user accounts
- Legible: Clear, readable data presentation
- Contemporaneous: Real-time data capture
- Original: First-capture data storage
- Accurate: Calibrated sensors, validated calculations
- Complete: No gaps in monitoring records
- Consistent: Standardized data formats
- Enduring: Long-term data retention
- Available: Data accessible when needed