Overview
ACL Digital Life Sciences successfully integrated Quality Assurance (QA) processes and resources for a clinical research organization (CRO) expanding to a new location. The company was also tasked with facilitating a smooth implementation of the Quality Management System (QMS) at the new site while ensuring compliance with regulatory requirements.
Challenges
Integrating two established QA processes: The CRO’s existing practices needed to be harmonized with the newly acquired location’s system
Maintaining regional compliance: The new QMS had to adhere to both international regulations (ICH-GCP, FDA, EMA) and local requirements.
Merging systems efficiently: Combining the existing systems presented a risk of creating redundancies or inefficiencies.
Benefits
- Strategic Approach: The gap analysis provided a clear roadmap for phasing out SOP updates, allowing for focused and prioritized implementation
- Streamlined Integration: The physical presence of the ACL Digital QA team member accelerated the integration process and ensured momentum
- Confidence and Clarity: In-person training resolved ambiguities and equipped the new location staff with the necessary knowledge and skills to implement the QMS effectively
- Enhanced Transparency: Regular updates kept the CRO informed of progress and facilitated open communication
