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.

Solution

Gap Analysis: A thorough review of both the parent and acquired organization’s QA processes identified areas for standardization potential process gaps
Standardization: ACL Digital Life Sciences strategized the creation of a global QMS that incorporated best practices from both existing systems. Regional Standard Operating Procedures (SOPs) were maintained to address local regulatory requirements
In-Person Support: A dedicated QA team member from ACL Digital was stationed at the new location. This physical presence facilitated a smooth integration process and ensured effective communication
Training and Implementation: ACL Digital’s experienced QA team provided in-person training at the new site, ensuring staff understood and could implement the standardized SOPs with confidence
Regular Updates: The CRO received regular updates on the integration progress, fostering transparency and trust