Computerized System Validation (CSV)
End-to-end CSV lifecycle support - URS, risk classification, IQ/OQ/PQ protocols, audit-trail review, and Validation Summary Reports. Aligned with FDA 21 CFR Part 11, EU GMP Annex 11, and ISPE GAMP 5.
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Quality Assurance & Gap Assessment
QA programme reviews, gap assessments against regulatory expectations, SOP development, CAPA management, data integrity audits, and inspection readiness support for regulated pharma operations.
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CQV & Thermal Mapping
Commissioning, Qualification, and Validation for pharmaceutical equipment and utilities. Thermal mapping studies for cold chain storage and temperature-controlled environments - aligned with EU GMP Annex 15.
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GMP Training
Instructor-led pharmaceutical training programmes - Cleaning Validation, CSV, Compressed Air Testing, and EU GMP Annex 1. Delivered online and on-site for pharma teams across Jordan and MENA.
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Pharma Digital Support & DVS
Compliance-first digital transformation - Pharma 4.0 strategy, AI-assisted validation, software implementation, and PHARPRO DVS: an FDA 21 CFR Part 11 compliant validation lifecycle platform.
Digital services details →