The client is a prominent biotechnology company committed to innovation and excellence in developing advanced biotechnological solutions. Due to the highly regulated nature of their operations, ensuring compliance of computerized systems with regulatory standards and internal policies is critical to their continued success and operational integrity.
The Solution by SQA Solution
SQA Solution provided a specialized Quality Systems and Compliance (QSC) Consultant whose responsibilities included:
- System Compliance and Validation: Leading and managing computerized system assessments, validations, and enhancements, ensuring alignment with regulatory standards.
- Data Integrity: Spearheading the Data Integrity program, including conducting gap and risk assessments and implementing remediation plans.
- Documentation Management: Developing and approving comprehensive SOPs, validation strategies, plans, and procedures to ensure consistent compliance.
- Quality Oversight: Reviewing and approving change controls, deviations, and CAPAs, ensuring corrective actions were effectively implemented.
- Project Leadership: Serving as a key SME, providing expert input in project meetings, workshops, and strategic initiatives.
Recommendations for Future Enhancements
- Continuous Training: Regular updates and training sessions on regulatory changes for continuous improvement.
- Optimized Resource Allocation: Ensuring adequate resources are allocated for comprehensive compliance and validation activities.
- Cross-Departmental Collaboration: Enhancing collaboration across teams to improve change management and operational efficiency.
Conclusion
The engagement of the SQA Solution QSC Consultant has significantly strengthened the biotechnology company’s ability to maintain regulatory compliance and enhance their quality management system. Despite facing operational challenges, the consultant effectively managed compliance risks and improved validation processes, contributing to the client’s ongoing success and operational excellence.
