Government and Public Sector

Introduction and Sector Challenges

The Pharmaceutical sector is undergoing rapid transformation driven by Pharma 4.0, digital manufacturing, and regulatory modernization.
Pharmaceutical manufacturers, research labs, and distribution centers are increasingly relying on MES systems, LIMS platforms, IoT-enabled equipment, and AI-driven drug development tools.

This digital evolution creates opportunities for increased productivity, quality control, and global distribution efficiency, but also exposes the sector to risks such as data integrity failures, cybersecurity threats, and regulatory non-compliance.

Cyber Threat Statistics

More than 70% of pharmaceutical companies reported at least one cybersecurity incident targeting manufacturing or research systems in the last 12 months (Source: IBM X-Force).
Regulatory agencies (like FDA, EMA, PIC/S) are increasingly focusing on data integrity and cybersecurity in GMP audits.

The sector must balance digital transformation goals with strict regulatory compliance and cyber resilience.

Objectives

Through our specialized consulting services for the Pharmaceutical Sector, MZYYAR aims to:

Strengthen cybersecurity across GMP environments, research platforms, and supply chain systems.
Ensure compliance with global pharmaceutical regulations: EU GMP Annex 11, 21 CFR Part 11, PIC/S, ISO 27001.
Support digital transformation initiatives aligned with Pharma 4.0.
Safeguard product data integrity and patient safety.
Minimize production downtime and regulatory risks.

Our Consulting Services for the Government Sector

We offer a wide range of consulting services tailored to pharmaceutical manufacturers, R&D labs, and distribution centers:

Cybersecurity Services

Pharma Cyber Risk Assessments (IT/OT/GxP Systems)
MES, LIMS, and SCADA Security Consulting
Data Integrity Risk Assessments for GMP Systems
Vulnerability Management and Penetration Testing for Pharmaceutical Environments
Incident Response Planning for Pharma Cyber Events
Supply Chain Cyber Risk Assessment (for Pharma Logistics)

Advisory & Compliance Services

Compliance Readiness for 21 CFR Part 11, EU GMP Annex 11, PIC/S Guidelines
CSV (Computer System Validation) Consulting for GxP Systems
Data Integrity Program Development
Business Continuity and Disaster Recovery Planning for Pharmaceutical Operations
GRC Framework Implementation for Pharmaceutical Enterprises
Audit Readiness Support for Regulatory Inspections (FDA, EMA, MOH)

Technology & Digital Transformation Services

Pharma 4.0 Readiness Assessments
Digital Manufacturing Security Strategy (MES, ERP Integration)
Secure Cloud Adoption for Pharma Data
IoT and Smart Manufacturing Security in Pharmaceutical Plants
Digital Quality Management System (QMS) Security Consulting
Data Analytics and AI Security in Drug Development Platforms

Key Standards and Frameworks

We help government organizations align with local and international standards, ensuring data protection and service availability.

Standard / Framework

21 CFR Part 11 (FDA)

Applicability

Electronic Records and Signatures

Reference

EU GMP Annex 11

Computerized Systems in GMP Environments

PIC/S Guidelines

Pharmaceutical Inspection Convention Standards

ISO/IEC 27001

Information Security for Pharma IT

ISO/IEC 22

Information Security for Pharma IT

GAMP 5

Validation of Automated Systems

NIST Cybersecurity Framework

OT and IT Cybersecurity

Local MOH Regulations

National Compliance Requirements

Expected Outcomes

We help industrial organizations achieve measurable and quantifiable outcomes, including:

Improved Pharma Cybersecurity Posture

≥30% reduction in vulnerabilities across government IT and OT assets

Regulatory Compliance

100% alignment with 21 CFR Part 11, Annex 11, PIC/S

Downtime Reduction in Energy Services

≥25% decrease in system-related production interruptions

Business Continuity Readiness

≥90% BCP implementation across GxP-critical sites

Pharma 4.0 Maturity Progress

Achieve Level 2 or 3 in Digital Maturity Assessment for Pharma

Contact Us

📧 Email: info@mzyyar.com 📞 Phone: +962 775 219 942 +962 796 306 8237 Location : Tariq- Jordan