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CSV Services
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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.

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FDA 21 CFR Part 11 EU GMP Annex 11 ISPE GAMP 5 ICH Q10
Founder-led project scoping and delivery

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What We Deliver

A complete, audit-ready CSV 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.

Regulatory Alignment

Every document is built to survive an inspection

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
Systems We Validate

Every computerised system in your GxP environment

From enterprise software to lab instruments - if it touches a regulated process, we validate it.

Cat 4
LIMS
LabWare, STARLIMS, Labvantage
Cat 4
ERP Systems
SAP, Oracle, Microsoft Dynamics
Cat 4
MES
Siemens, Rockwell, Werum PAS-X
Cat 3/4
SCADA / DCS
Wonderware, Ignition, DeltaV
Cat 4
QMS Software
MasterControl, Veeva, Pilgrim
Cat 3
Lab Instruments
HPLC, dissolution, balance systems
Cat 4
Chromatography DS
Empower, Chromeleon, OpenLAB
Cat 4
Document Control
Documentum, Ennov, SharePoint GxP
Cat 3/4
BMS / EMS
Environmental monitoring systems
Cat 4
Serialisation / Track & Trace
Antares, Systech, rfxcel
Cat 4
Clinical Trial Systems
EDC, CTMS, eTMF platforms
Not listed? Ask us →
FAQ

Common CSV questions

CSV is the documented process of demonstrating that a computerized system used in pharmaceutical manufacturing or quality control consistently does what it is designed to do. It is mandated by FDA 21 CFR Part 11, EU GMP Annex 11, and ISPE GAMP 5.
PHARPRO provides the complete CSV package: User Requirements Specification (URS), risk classification, Validation Master Plan, IQ/OQ/PQ protocols, execution support, discrepancy management, and final Validation Summary Report - all audit-ready from day one.
A typical CSV project for a single system runs 6–12 weeks, depending on system complexity and risk category. We define the timeline clearly in the project proposal. Expedited timelines are available for inspection-driven projects.
Yes. Documentation, risk assessment, protocol development, and review cycles are all conducted remotely with no loss of quality. On-site visits are arranged for IQ/OQ activities that require physical system access.
GAMP 5 (Good Automated Manufacturing Practice) is an ISPE framework that defines a risk-based approach to CSV. It classifies software into categories (1, 3, 4, and 5 in the Second Edition) based on complexity and GxP impact, then prescribes proportionate validation effort for each. PHARPRO uses GAMP 5 as the primary methodology across all CSV engagements.
IQ (Installation Qualification) verifies the system is installed to specification. OQ (Operational Qualification) demonstrates it operates as intended across its defined range. PQ (Performance Qualification) confirms it performs consistently under real or simulated production conditions. Together they form the core qualification lifecycle for any GxP computerized system.
A VSR is the final closure document for a CSV project. It summarises all validation activities, references executed protocols, records outcomes of each qualification phase, documents deviations and their resolutions, and states the overall validation conclusion including residual risks. It is the primary evidence package reviewed during FDA, EU GMP, or WHO inspections.
CSV consulting cost varies based on system complexity, GAMP 5 category, and project scope. A single GAMP Category 4 system (e.g. LIMS or ERP) typically ranges from $8,000–$20,000 USD for a full URS-through-VSR engagement. PHARPRO provides fixed-price proposals with no hourly billing - contact us for a free scoping call and quote.
Yes. PHARPRO validates cloud-hosted and SaaS GxP systems in full compliance with GAMP 5 and applicable FDA/EU GMP requirements. The approach includes supplier qualification, infrastructure and data security review, system-level IQ/OQ/PQ protocols, and audit trail verification - addressing the additional complexity of shared infrastructure and vendor responsibility boundaries.
Periodic review is a formal re-assessment of a validated computerized system to confirm it remains in a validated state. EU GMP Annex 11 clause 11 and FDA expectations both require periodic review - typically annually or after significant change. PHARPRO conducts periodic reviews covering system change log analysis, SOP currency, audit trail integrity, and user access review, producing a Periodic Review Report suitable for inspection.
GxP spreadsheets are typically classified as GAMP 5 Category 4 tools and require a validation approach proportionate to their GxP risk. PHARPRO's spreadsheet validation service includes a risk assessment, URS, functional specification, IQ/OQ test cases including macro and formula verification, and a Validation Summary Report - ensuring the spreadsheet meets Part 11 and data integrity requirements.
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.
PHARPRO is a specialist pharmaceutical consulting firm based in Amman, Jordan, delivering computerized system validation (CSV) projects across the MENA region - including Jordan, UAE, Saudi Arabia, Egypt, and Kuwait. CSV engagements are practitioner-led and aligned with FDA 21 CFR Part 11, EU GMP Annex 11, and ISPE GAMP 5. Fixed-price proposals and remote delivery are available for regional clients. Contact us for a free scoping call.
FDA 21 CFR Part 11 is the US regulation governing electronic records and electronic signatures in FDA-regulated environments. EU GMP Annex 11 is the European equivalent covering computerised systems in pharmaceutical manufacturing. Both require audit trails, access controls, data integrity, and validated systems - but differ in scope and specific provisions. PHARPRO designs all CSV projects to satisfy both frameworks simultaneously, regardless of which authority will inspect.
If a system fails qualification testing, the failure is documented as a discrepancy or deviation. The root cause is investigated, a corrective action is implemented, and affected test cases are re-executed after remediation. PHARPRO manages the full discrepancy lifecycle - root cause analysis, CAPA, retesting, and formal closure - ensuring the qualification package remains coherent and inspection-ready even when failures occur during execution.
Most CSV activities - URS development, GAMP 5 risk classification, Validation Master Plan, protocol authoring, review and approval cycles, and final reporting - are conducted remotely with no loss of quality. On-site visits are arranged only for IQ/OQ execution phases requiring physical system access. For SaaS or cloud-hosted systems, the entire engagement can often be completed remotely. Contact us to discuss your project.
Verified Project Record

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.

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Related Insights

Go deeper on CSV methodology

In-depth guides from Mohammad Awawdeh on IQ/OQ/PQ, GAMP 5, URS writing, and validation documentation best practice.

Qualification Guide
IQ OQ PQ Explained: What Each Phase Requires
Regulatory basis, documentation requirements, and what auditors look for in each qualification phase.
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GAMP 5
GAMP 5 Risk Categories: How to Classify Your System
What changed in the Second Edition and how to assign the correct category to any computerized system.
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Documentation
How to Write a URS for a Pharmaceutical Computerised System
Structure, GxP requirements, and a step-by-step guide to writing a compliant User Requirements Specification.
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Documentation
What Is a Validation Master Plan? Requirements & Guide
What a VMP must contain, who owns it, and how to keep it current through the system lifecycle.
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Risk Management
CSV Risk Assessment: Applying GAMP 5 Principles
How to conduct a risk assessment for computerized systems and document it to regulatory standards.
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SaaS & Cloud
CSV for SaaS & Cloud Applications in Pharma
Validation approach, vendor qualification, and documentation strategy for cloud-hosted GxP systems.
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Find compliance gaps before auditors do. SOP reviews, CAPA management, and QA programme assessments.

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Equipment qualification and temperature distribution studies for controlled pharmaceutical environments.

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GMP Training Programmes

Instructor-led CSV, data integrity, and GMP training - online and on-site - for pharmaceutical teams.

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From the Compliance Library

Related Reading

IQ OQ PQ Explained

What each qualification phase requires, documentation standards, and acceptance criteria — with a 2026 update.

Read the guide →

GAMP 5 Software Categories

How to classify your computerised system under GAMP 5 and what each category means for your validation scope.

Read the guide →

How to Write a URS

Structure, content requirements, and common mistakes when writing a User Requirements Specification for a GxP system.

Read the guide →

EU GMP Annex 11 Checklist

A practical compliance checklist for computerised systems — audit trails, electronic signatures, and supplier assessment.

Read the guide →

Why PHARPRO

Practical CSV validation support with audit-defensible outputs

Hands-on deliveryWork is scoped around your systems, documents, people and regulatory market.
Clear deliverablesDefined responsibilities, review cycles, acceptance criteria and closure evidence.
Risk-based approachEffort is focused on product quality, patient safety and data-integrity risk.
MENA reachSupport across Jordan, UAE, Saudi Arabia and Egypt.

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.

Free Download: The 50-Question Pharma Compliance Checklist 50 pre-inspection questions covering CSV, QA, data integrity, training, and CAPA - aligned with FDA 21 CFR Part 11 & EU GMP Annex 11. Free, instant access.
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