Delivered Seamless QMS Integration for a Global CRO
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.
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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
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
