Service Overview
As pharmaceutical manufacturing and quality control laboratories become digitalized, automated computer systems—from PLC equipment controllers and SCADA networks to LIMS, ERP, and QMS software—must be validated to guarantee data integrity, system security, and reliable performance.
QEEMA Egypt offers specialized Software Validation and Computer System Validation (CSV) services. Guided by GAMP 5 (Good Automated Manufacturing Practice) risk-based frameworks, we support pharmaceutical companies in qualifying software applications and automated instruments to pass EDA, WHO, and FDA regulatory audits seamlessly.
Core Scope & Technical Deliverables
Computer System Validation (CSV) per GAMP 5
Risk-based classification and validation life-cycle execution tailored for GAMP Categories 3 (Configured), 4 (Configurable), and 5 (Custom) systems.
- GAMP Category 3, 4, and 5 systems
- Validation Master Planning (VMP)
- Life-cycle risk management
IQ / OQ / PQ Software Protocols
Preparation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test scripts for laboratory software and plant automation.
- Lab software (HPLC/GC CDS, LIMS)
- PLC & SCADA automation test scripts
- System security & permission checks
URS & Risk Assessment Development
Drafting clear User Requirements Specifications (URS), Functional Specifications (FS), and conducting Functional Risk Assessments (FMEA/GAMP Risk Matrix).
- User Requirements Specification (URS)
- Traceability Matrix (TM) mapping
- FMEA risk matrix evaluation
21 CFR Part 11 & Data Integrity Compliance
Thorough auditing and verification of electronic signatures, audit trail functionality, access controls, password security, and ALCOA+ data governance principles.
- Audit trail verification & log checks
- Electronic signature authentication
- ALCOA+ data governance audit
Implementation Methodology
System Categorization & Inventory
Audit existing automated systems and software to categorize them under GAMP 5 guidelines.
URS & Traceability Matrix
Establishing URS and mapping functional requirements to specific IQ/OQ test scripts via a Traceability Matrix (TM).
Protocol Execution & Audit Trail Testing
Testing user permissions, password policies, audit trail logs, data backup/restore, and disaster recovery scenarios.
Validation Summary Report
Compiling audit trail verification evidence and issuing formal CSV completion reports for QA sign-off.
Target Sectors & Applications
Our specialized consulting services cater to: