Digital QMS (QMex) – EIPICO

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

Client: EIPICO (The Egyptian International Pharmaceutical Industries Company)
Sector: Pharmaceutical Manufacturing
Location: Egypt

Establishing a Smart Quality Management Software System (QMex) at EIPICO (2)
Establishing a Smart Quality Management Software System (QMex) at EIPICO

Background

EIPICO, Egypt’s largest pharmaceutical manufacturer, initiated a digital transformation program to modernize its Quality Management System and enhance operational efficiency across its primary manufacturing sites. The existing paper-based QMS created challenges in document traceability, deviation handling, and cross-departmental coordination, affecting agility and regulatory preparedness.

Objective

To implement a fully integrated electronic Quality Management System powered by QMex, enabling end-to-end digital oversight of quality operations across EIPICO and EIPICO 3. The objective was to strengthen compliance, streamline communication, and establish a sustainable digital framework aligned with cGMP and ISO requirements.

Scope of Work

QMex Implementation Across Two Manufacturing Sites

Electronic Document Control, CAPA, and Deviation Management.
Change Control and Risk Management modules.
Training and Competency Management systems.
Internal Audit Management.
Integration with ERP and LIMS platforms for seamless data flow.

Challenges Identified

Developed a transformation roadmap connecting corporate objectives with QMex implementation milestones.
Conducted full system validation (IQ/OQ/PQ) ensuring data integrity and regulatory compliance.
Customized QMex workflows to align with EIPICO’s procedures and approval structures.
Delivered comprehensive training and digital competency programs to support user adoption.
Established real-time monitoring dashboards to enhance quality oversight and decision-making.

Results Achieved

Unified Digital QMS & Enhanced Operational Efficiency

Successful deployment of QMex across EIPICO and EIPICO 3 under full regulatory compliance.
Reduced document processing and approval time by over 40%, improving productivity and interdepartmental collaboration.
Strengthened transparency and traceability across the full quality lifecycle.
Achieved harmonized digital operations across both manufacturing sites, supporting audit readiness and operational alignment.

Conclusion

Through Agon’s digital transformation expertise and the implementation of QMex, EIPICO transitioned into a fully electronic, data-driven quality ecosystem. The project marks a major milestone in EIPICO’s modernization strategy, positioning the company among the region’s leaders in digital quality excellence.

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