GAMP 5 Validation Consultant for Risk-Based Pharmaceutical CSV
Founder-led GAMP 5 validation consulting from system classification and supplier assessment through URS, risk-based testing, traceability and defensible closure.
PHARPRO computerized system validation (CSV) consulting delivers the complete URS-through-VSR documentation lifecycle for pharmaceutical and life sciences companies in Jordan, UAE, Saudi Arabia, and across the MENA region. Fixed-price projects aligned with FDA 21 CFR Part 11, EU GMP Annex 11, and ISPE GAMP 5. Remote delivery available. Typical engagement: 6–12 weeks per system.
Start your CSV project
Tell us about your system - we'll respond within one business day with a clear scope and fixed-price proposal.
What's included in a CSV validation package?
Every engagement produces structured, traceable documentation that holds up in an FDA, EU GMP, or WHO inspection.
User Requirements Specification (URS)
Structured URS aligned to regulatory expectations - covering functional, performance, and compliance requirements with full traceability.
Risk Classification & Assessment
GAMP 5 category assignment, GxP impact analysis, and risk-based validation strategy - proportionate to system complexity.
Validation Master Plan (VMP)
Site-level or project-level VMP establishing scope, responsibilities, documentation standards, and acceptance criteria framework.
IQ / OQ / PQ Protocols & Reports
Installation, Operational, and Performance Qualification - written, executed, and reported to regulatory standards with full discrepancy management.
Audit Trail & Data Integrity Review
21 CFR Part 11 and EU GMP Annex 11 audit trail verification - covering access controls, timestamps, change records, and ALCOA+ compliance.
Validation Summary Report (VSR)
Comprehensive closure report consolidating all validation activities, outcomes, and residual risks - ready for regulatory filing.
How does PHARPRO align CSV documentation with FDA, EU GMP and GAMP 5?
We write to the current version of each framework, cross-referencing where requirements overlap or diverge.
| Framework | Scope | Applies To |
|---|---|---|
| FDA 21 CFR Part 11 | Electronic records, e-signatures, audit trails | US FDA-regulated markets |
| EU GMP Annex 11 | Computerised systems in GMP-regulated operations | EMA / EU-regulated markets |
| ISPE GAMP 5 | Risk-based approach to CSV - categories 1–5 | All regulated pharma environments |
| ICH Q10 | Pharmaceutical Quality System lifecycle management | Global regulated markets |
Every computerised system in your GxP environment
From enterprise software to lab instruments - if it touches a regulated process, we validate it.
Common CSV questions
CSV experience with transparent scope
Review the dated CSV, ERP, BMS, software-gap and training engagements. Client logos, quotations and outcome metrics remain withheld until reuse permission is confirmed.
View project record →Go deeper on CSV methodology
In-depth guides from Mohammad Awawdeh on IQ/OQ/PQ, GAMP 5, URS writing, and validation documentation best practice.
Complete compliance support
Related Reading
Why PHARPRO
Practical CSV validation support with audit-defensible outputs
PHARPRO aligns each engagement with the regulations and guidance applicable to the client’s product, market and quality system. Final responsibility and approval remain with the regulated company.
Need a focused FDA Part 11 assessment?
Review electronic records, audit trails, e-signatures, access controls and remediation requirements with PHARPRO's dedicated 21 CFR Part 11 consulting service for the Middle East.
More questions
Which regulatory frameworks does PHARPRO's CSV work cover?
All CSV engagements are aligned with FDA 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5 (5th and 6th editions), ICH Q10, and applicable WHO guidelines. We reference the current regulatory landscape and flag any upcoming changes.
What is the difference between IQ, OQ, and PQ in pharmaceutical validation?
CSV (Computerized System Validation) and computerised system validation refer to the same regulated process. The US spelling is "computerized" (FDA/ICH usage) while the UK/EU spelling is "computerised" (EU GMP/MHRA). Both describe the documented lifecycle of demonstrating that a software system used in a regulated pharmaceutical environment consistently performs as intended.
What is the difference between CSV and computerised system validation?
CSV (Computerized System Validation) and computerised system validation refer to the same regulated process. The US spelling is "computerized" (FDA/ICH usage) while the UK/EU spelling is "computerised" (EU GMP/MHRA). Both describe the documented lifecycle of demonstrating that a software system used in a regulated pharmaceutical environment consistently performs as intended.
What changed in GAMP 5 Second Edition compared to the first edition?
GAMP 5 Second Edition (published by ISPE in 2022) introduced significant changes to how pharmaceutical companies approach computerized system validation. Key changes include: revised software categories (removing Category 2, redefining categories 1, 3, 4, and 5), a stronger emphasis on critical thinking and science- and risk-based approaches rather than prescriptive documentation, updated guidance on agile development and cloud/SaaS systems, and increased focus on data integrity throughout the validation lifecycle. PHARPRO applies GAMP 5 Second Edition methodology to all CSV projects, ensuring your validation approach reflects the current regulatory expectation.
What CSV validation services does PHARPRO provide for pharmaceutical companies in the Middle East?
PHARPRO is a specialist CSV consulting firm based in Amman, Jordan, delivering full-lifecycle computerized system validation across the Middle East and MENA region — including UAE, Saudi Arabia, Egypt, Kuwait, and Bahrain. Services include URS authoring, GAMP 5 2nd Edition risk classification, IQ/OQ/PQ protocol development, audit trail review, 21 CFR Part 11 and EU GMP Annex 11 gap assessments, and periodic review. Remote delivery is available throughout the region with no compromise on quality.