Inspection-Ready CSV. From Planning Through Closure.
End-to-end CSV lifecycle - URS, risk classification, IQ/OQ/PQ protocols, and summary reports. Aligned with FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
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.
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.
Client Reviews
What our clients say
"PHARPRO supported us with strong technical understanding and practical execution. Their work added real clarity to our validation and compliance activities."
AG
Axantia Group
Pharmaceutical Manufacturer
"Professional, responsive, and perfectly aligned with the demands of our regulated environment. PHARPRO delivered without ambiguity."
DD
Dar Al Dawa
Pharmaceutical Manufacturer
"PHARPRO helped us approach validation and quality in a more structured, inspection-focused way. Their risk-based methodology was exactly right."
AH
Al Hayat Pharmaceuticals
Pharmaceutical Manufacturer
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Go deeper on CSV methodology
In-depth guides from the PHARPRO team on IQ/OQ/PQ, GAMP 5, URS writing, and validation documentation best practice.
Free Download: The 50-Question Pharma Compliance Checklist50 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.