Computer System Validation Services in Egypt
On-site, Arabic-supported GAMP 5 and CSA computer system validation (CSV) for pharmaceutical, food, water and chemical organisations — evidencing compliance with EDA, EGAC ISO/IEC 17025, FDA 21 CFR Part 11 and EU Annex 11.
The Local CSV Partner for Egyptian Regulated Industry
Computer system validation (CSV) is how a regulated organisation proves that its software — a LIMS, a QMS, an ERP or a chromatography data system — does what it is supposed to do, and nothing it shouldn’t. For laboratories and manufacturers in Egypt, validation is no longer a formality: Egyptian Drug Authority (EDA) inspections and EGAC ISO/IEC 17025 assessments now examine computerised-system control and data integrity directly, and any lab serving export markets is held to FDA 21 CFR Part 11 and EU Annex 11.
CORPEX Informatics is an Egyptian company, headquartered in the New Administrative Capital, that delivers CSV on-site across Egypt and the wider MENA region. We pair a GAMP 5 and CSA-aligned methodology with something global consultancies cannot offer Egyptian teams: Arabic-speaking validation engineers, execution on your premises, and contracts in Egyptian Pounds.
Why Egyptian Labs and Manufacturers Are Validating Now
Three pressures are turning validation from a paper exercise into an operational requirement for Egyptian organisations:
- EDA data-integrity scrutiny. Egyptian Drug Authority inspections increasingly focus on ALCOA+ data integrity and on whether computerised systems are validated and controlled — spreadsheets and unvalidated software are where findings originate.
- EGAC ISO/IEC 17025 accreditation. Assessors examine control of data and electronic records directly; a validated system turns that from a scramble into evidence that is already on file.
- Export compliance. Labs and manufacturers serving multinational clients or export markets must meet FDA 21 CFR Part 11 and EU Annex 11 for electronic records and signatures — a bar only a validated system clears.
Why Choose a Local Validation Partner
Global consultancies are capable, but they are priced and staffed for large multinationals. Here is where a local partner changes the equation for an Egyptian organisation.
Arabic & English
Arabic-speaking validation engineers and bilingual documentation, so your QA team, analysts and EDA/EGAC auditors all work in the language they know best.
Execution in Egypt
We execute IQ/OQ/PQ on your premises in Cairo, the New Capital and across Egypt — not just a remote protocol pack you have to run yourself.
Egyptian Pound Contracts
Scoped and billed in EGP, sized for Egyptian labs and manufacturers — not enterprise dollar day-rates built for global pharma.
EDA & EGAC Fluency
We know what an EDA inspector and an EGAC assessor actually ask for, so the validation package is built around the evidence they expect.
Any Vendor’s System
Validation for CORPEX products or as an independent service for third-party LIMS, QMS, ERP and CDS already installed in your facility.
A Team You Can Call In
Same time zone, on-site for execution, audits and remediation — the partnership Egyptian QA managers rely on when an inspection date is set.
One Validated System, Every Regulator
Egyptian organisations sit under several overlapping expectations at once. A single, well-executed validation is what lets one system answer to all of them:
- Egyptian Drug Authority (EDA) — local GMP inspections covering computerised-system control and ALCOA+ data integrity.
- EGAC ISO/IEC 17025 — accreditation for testing labs, where control of data and electronic records is assessed directly.
- FDA 21 CFR Part 11 — electronic records and signatures for anything touching the US market.
- EU Annex 11 — the European standard for computerised systems in GxP environments.
- GAMP 5 & WHO GMP — the risk-based lifecycle and manufacturing baseline the whole industry validates against.
What Your Validation Package Contains
The package is the evidence. This is the documentation produced across a CORPEX CSV project — the same set an EDA, EGAC or FDA inspector expects to review.
| Deliverable | Purpose |
|---|---|
| Validation Master Plan (VMP) | Defines the scope, approach, roles and acceptance criteria for the whole validation. |
| User Requirements Specification (URS) | Captures what the system must do, in the language of the regulation and the workflow. |
| Functional Risk Assessment | Ranks each function by risk to quality, safety and data integrity to focus testing (GAMP 5 / CSA). |
| Requirements Traceability Matrix (RTM) | Links every requirement to its test, proving nothing was missed. |
| IQ / OQ / PQ Protocols & Reports | Executed evidence the system is installed, operates, and performs as intended. |
| Validation Summary Report | Concludes the system is fit for its intended use and released for GxP operation. |
Systems We Validate in Egypt
CSV for CORPEX products or as an independent service for third-party systems.
LIMS & CDS
Laboratory Information Management Systems, chromatography data systems and ELNs — the data backbone EDA and EGAC examine first.
eQMS
Electronic Quality Management Systems: document control, CAPA, change control, deviations and audit trails.
ERP & MES
Enterprise resource planning, manufacturing execution and environmental monitoring systems operating under GxP.
Our Risk-Based Approach
GAMP 5 and CSA-aligned — rigorous where risk lives, efficient everywhere else.
Assess & Plan
We define intended use, draft the VMP and URS, and run a functional risk assessment to focus effort on high-risk functionality (CSA).
Qualify (IQ/OQ/PQ)
We execute Installation, Operational and Performance Qualification on-site, tracing every requirement to its test in the RTM.
Report & Maintain
We deliver the Validation Summary Report and, where needed, periodic review and change control to keep the system in a validated state.
Built for Egyptian Regulated Industry
CORPEX solutions and services are trusted by leading Egyptian pharmaceutical and industrial organisations — including Marcyrl Pharmaceutical Industries, ATCO Pharma, October Pharma, Orchidia Pharmaceutical Industries, Arabco, SEKEM, and the Egyptian Drug Authority (EDA). That local footprint means we understand the documentation an EGAC assessor expects and the computerised-system controls an EDA inspection scrutinises.
Get Your Systems Inspection-Ready
Talk to a local CORPEX validation specialist about a CSV plan for your LIMS, QMS or ERP — scoped to your regulators and your budget, in Arabic or English.
Request a ConsultationCSV in Egypt — Frequently Asked Questions
Is there a computer system validation (CSV) provider based in Egypt?
Yes. CORPEX Informatics is an Egyptian company headquartered in the New Administrative Capital that provides on-site CSV for laboratories and manufacturers across Egypt and the MENA region — in Arabic and English, on your premises, and contracting in Egyptian Pounds.
Which regulations does CORPEX validate against in Egypt?
EDA GMP and EGAC ISO/IEC 17025 locally, while simultaneously meeting FDA 21 CFR Part 11, EU Annex 11, GAMP 5 and WHO GMP for export markets. One validation, executed once, answers to all of them.
Which systems can CORPEX validate?
LIMS, electronic QMS, ERP, chromatography data systems (CDS), electronic laboratory notebooks (ELN), SCADA/MES and environmental monitoring systems — for CORPEX products or as an independent service for third-party systems already installed in your facility.
What is the difference between CSV and CSA?
Computer Software Assurance (CSA) is the FDA’s modern, risk-based evolution of CSV. It concentrates scripted testing and documentation on high-risk functions and allows lighter testing for low-risk ones. CORPEX applies a CSA-aligned approach so validation is rigorous where it matters and efficient elsewhere, cutting cost and timeline.
What documents will I receive from a CSV project?
A complete package: VMP, URS, Functional Risk Assessment, Requirements Traceability Matrix, executed IQ/OQ/PQ protocols and reports, and a Validation Summary Report — exactly the evidence an EDA, EGAC or FDA inspector expects to review.
Does CORPEX deliver validation on-site and in Arabic?
Yes. We deliver CSV on-site in Cairo, the New Administrative Capital and across Egypt, with Arabic-speaking validation engineers, and can provide documentation in Arabic and English.
How long does a computer system validation take in Egypt?
It depends on system complexity, the number of functions in scope and the risk level. A focused single-system validation is typically completed in a few weeks; an enterprise platform with many integrations takes longer. A risk-based, CSA-aligned approach shortens the timeline by focusing on high-risk functionality.