Most pharmaceutical companies operating across MENA have at least 10–30 GxP-critical computerised systems. LIMS, ERP, SCADA, MES, EDMS, quality management platforms, validated spreadsheets — each one potentially carrying a compliance gap that regulators can and do cite during inspections.
The question is not whether gaps exist. The question is whether you find them before the inspector does. PHARPRO's Software & CSV Gap Assessment is a structured, expert-led review of your validated system landscape — pinpointing compliance gaps in critical areas such as electronic signatures, data integrity, and system validation — mapped against FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5, and delivered with six concrete outputs including a written gap report, risk assessment, CAPA plan, and compliance roadmap.
Inspectors work from structured checklists. They know exactly which 21 CFR Part 11 and Annex 11 requirements to probe. If your documentation doesn't answer those probes before they walk in, you are already behind. A gap assessment changes that.
What Undetected CSV Gaps Cost
The cost of a PHARPRO gap assessment is a fraction of what a single critical observation costs to remediate — not counting the indirect costs of delayed product releases, repeat inspections, or regulatory agency correspondence.
What the Assessment Covers
GxP System Inventory
Complete mapping of all computerised systems in scope — LIMS, ERP, MES, SCADA/DCS, EDMS, QMS, instruments, and standalone applications.
GAMP 5 Risk Categorisation
Each system assessed against GAMP 5 Second Edition categories. Incorrect categorisation is one of the most common — and most cited — CSV gaps.
Validation Documentation Review
Review of existing VMP, URS, risk assessments, IQ/OQ/PQ protocols and reports. Identification of missing, inadequate, or out-of-date documentation.
21 CFR Part 11 & Annex 11 Compliance
Audit trail completeness, e-signature controls, access management, backup & recovery, and system lifecycle controls — checked against current regulatory expectations.
Data Integrity Controls
ALCOA+ review across critical data flows. Raw data access controls, data review processes, and audit trail review procedures assessed against MHRA guidance.
Excel & Spreadsheet Validation
GxP-critical spreadsheets identified, validation status confirmed, and gaps against 21 CFR Part 11 and data integrity expectations documented.
The Most Common Gaps PHARPRO Finds
How many of these gaps exist in your environment right now? Most companies don't know until an inspector tells them. Request a consultation and find out.
Request Free Consultation →The Assessment Methodology — 6 Steps
Optional next step: PHARPRO can execute the remediation — writing validation documentation, executing qualification protocols, or implementing corrective actions identified in the gap report. This is available as a separate engagement based on your priorities and timeline.
Who Needs a CSV Gap Assessment
Why PHARPRO for Your Gap Assessment
- 8+ years in pharmaceutical manufacturing & compliance — real-world experience writing validation documentation, executing qualification protocols, and managing system implementations across MENA's leading pharmaceutical manufacturers
- Proven delivery of enterprise CSV gap assessments — delivered for Al Hayat Pharmaceuticals, Axantia Group, JFDA, and leading manufacturers across Jordan, UAE, KSA, Egypt, and Oman
- Experience with ERP, DMS, QMS, and validation platforms — PHARPRO has assessed SAP, Oracle, Empower, and custom systems across regulated environments
- Dual regulatory fluency — FDA 21 CFR Part 11 and EU GMP Annex 11 expertise in a single team, plus WHO TRS 996, SFDA, and JFDA knowledge for regional compliance
- Inspector-ready output — the gap report, CAPA plan, and regulatory alignment checklist are structured to answer the exact questions inspectors ask
- No sales agenda for the assessment — the gap report and all six deliverables are yours regardless of whether you engage PHARPRO for remediation
- DVS software available — clients who proceed with remediation have access to PHARPRO DVS for accelerated documentation delivery
تقييم الفجوات في الأنظمة الحاسوبية — بالعربية
خدمة PHARPRO لتقييم فجوات CSV والأنظمة البرمجية — مراجعة شاملة لجميع الأنظمة الحاسوبية الحيوية في منشأتك مقارنةً بمتطلبات FDA 21 CFR Part 11، وAnnex 11 الأوروبية، وGAMP 5. المخرج: تقرير مكتوب بالفجوات مصنّفةً حسب الخطورة، وخارطة طريق للمعالجة. الاستشارة الأولى مجانية. للتواصل: [email protected] أو واتساب +962 79 856 5807
Common Questions
How is this different from an internal self-assessment?
Internal assessments are valuable but carry blind spots — teams often validate against their current understanding of requirements, which may not reflect the latest regulatory guidance or inspector expectations. PHARPRO brings external expertise, current regulatory knowledge, and an inspector's perspective that internal teams rarely replicate.
What if my systems are partially validated?
Partial validation is the most common finding — and exactly what the gap assessment is designed to address. PHARPRO maps what exists, documents what's missing, and prioritises remediation by regulatory risk. You don't need to be fully validated to start an assessment; the assessment tells you where you are.
Do you work remotely or on-site?
Both. Documentation reviews are conducted remotely via secure file sharing. System configuration reviews may be conducted remotely (screen share/VPN access) or on-site depending on system type and client preference. PHARPRO serves clients across Jordan, UAE, KSA, Egypt, and internationally.
How do I request an assessment?
Complete the form below or contact us directly via email or WhatsApp. An initial scoping call is scheduled within 48 hours of your request — no preparation required, just a summary of your GxP system landscape.
Request Your Free CSV & Software Gap Assessment Consultation
Tell us about your environment. We'll schedule a scoping call within 48 hours — no preparation needed.
Or reach us directly: [email protected] · WhatsApp +962 79 856 5807