The GxP System Validation Process
Good Automated Manufacturing Practices (GAMP 5) is an advisory framework published by the International Society of Pharmaceutical Engineering (ISPE). It provides guidelines and best practices for the validation of GxP computerized systems, ensuring compliance and data integrity.
Risk Assessment in Validation
During validation, GxP-regulated functional software processes must be identified and assessed for potential risks. This involves evaluating the probability of occurrence and detection for each GxP functional process or group of processes to determine risk priority—ultimately shaping the testing strategy.Texium Solutions Group provides expert support in:
- Conducting Risk Assessments to identify key risk factors
- Mitigating Risk Impacts that influence testing outcomes
- Defining a Risk-Based Testing Strategy for compliance and efficiency
GxP Compliance Best Practices
At Texium Solutions, we help organizations establish a robust compliance framework for GxP system validation, ensuring adherence to regulatory requirements while optimizing efficiency.
By integrating these best practices, Texium Solutions ensures your GxP systems remain compliant, audit-ready, and aligned with global regulatory standards.
Structured Compliance Framework
Establish policies, procedures, and guidelines specific to GxP validated systems, with clear roles and responsibilities.
Regulatory Awareness & Monitoring
Stay updated on GxP regulations, guidelines, and industry best practices, enabling proactive compliance and timely updates.
Risk-Based Approach
Prioritize compliance efforts by assessing risks that impact product quality, patient safety, and regulatory adherence.
Validation & Documentation
Ensure GxP systems operate as intended through periodic reviews, deviation management, and maintaining complete validation records.
Document Control System
Implement structured processes for document creation, revision, approval, and archiving, ensuring accessibility and compliance.
Employee Training & Compliance Culture
Maintain comprehensive training programs and records to align with evolving regulatory requirements.
Data Integrity & Security
Enforce strong audit trails, data backups, access controls, and periodic integrity reviews to ensure data reliability.
Oversight & Continuous Improvement
Conduct regular compliance reviews, track performance metrics, and identify opportunities for enhancing compliance efficiency.
Industries We Serve
Pharmaceuticals & Life Sciences
Ensuring FDA & GxP compliance for drug development
Healthcare & Medical Devices
HIPAA compliance for secure patient data management.
Technology & Manufacturing
Regulatory frameworks for system validation and automation.
Why Choose Texium Solutions?
Proven Expertise
Decades of experience in research informatics and regulatory compliance.
End-to-End Support
From consultation to implementation, we offer comprehensive solutions.
Scalability & Security
Future-proof solutions designed for high-performance research environments.
Seamless Integration
Compatible with leading industry platforms for a unified digital experience.
Ensure GxP Compliance with Confidence!
Partner with Texium Solutions for expert GxP system validation, risk-based assessments, and regulatory compliance.
