Digital QMS (QMex) – ACDIMA

Establishing a Smart Quality Management Software System (QMex) at ACDIMA

Client: ACDIMA (Arab Company for Drug Industries and Medical Appliances)
Sector: Pharmaceutical Manufacturing and Group Management
Location: Egypt

Background

ACDIMA, a leading regional pharmaceutical group overseeing multiple manufacturing subsidiaries, sought to unify and digitalize its quality systems to enhance compliance alignment and operational visibility across sites. To streamline documentation, CAPA control, and quality analytics, the organization required a centralized digital Quality Management Software platform.

Objective

To implement QMex, a cloud-based Quality Management Software solution, across ACDIMA’s subsidiaries, establishing a unified digital ecosystem that supports regulatory compliance, cross-site collaboration, and continuous improvement.

Scope of Work

Multi-Site QMex Deployment Strategy

Implementation of a centralized Document Management System.
Standardized CAPA and Deviation management across all subsidiaries.
Real-time quality performance dashboards and KPI monitoring.
Electronic training management for quality and production personnel.
Full system validation and integration with ACDIMA’s corporate IT framework.

Challenges Identified

Varying digital maturity levels across different ACDIMA subsidiaries.
Complex approval workflows requiring tailored system configurations.
Data migration and harmonization from multiple legacy platforms.

Solutions Implemented

Digital QMS Standardization & Validation

Designed a scalable and harmonized QMex digital architecture.
Configured QMex to align with ACDIMA’s multi-tier organizational structure.
Delivered user training and change management programs to strengthen adoption.
Executed full Computer System Validation (CSV) in compliance with GAMP 5 and 21 CFR Part 11 requirements.

Results Achieved

Unified Digital Quality Ecosystem & Enhanced Compliance

Achieved full digital integration across ACDIMA’s sites with aligned QMS operations.
Reduced audit preparation time by 50% through real-time documentation and compliance dashboards.
Strengthened management oversight with reliable data-driven insights.
Positioned ACDIMA as a regional leader in digital quality transformation across the MENA pharmaceutical sector.

Conclusion

Under Agon’s strategic implementation approach, ACDIMA successfully transitioned from fragmented paper-based processes to a unified, intelligent QMex platform. The transformation strengthened compliance governance, enhanced operational efficiency, and advanced ACDIMA’s vision for complete digital quality excellence.

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