Quality Management System (QMS) Software in Egypt
An Egyptian-built, Arabic-supported electronic Quality Management System (eQMS) for pharmaceutical, food and manufacturing companies — document control, CAPA, deviations, change control, audits and training, compliant with ISO 9001, EDA GMP, EGAC ISO/IEC 17025 and FDA 21 CFR Part 11.
The Local eQMS Partner for Egyptian Regulated Industry
A Quality Management System (QMS) is the operating system of a compliant organisation — it controls documents, routes deviations and CAPAs, manages change, schedules audits and training, and holds the audit trail behind every quality decision. For Egyptian pharmaceutical, food and manufacturing companies, moving from paper and spreadsheets to an electronic QMS (eQMS) is now a regulatory expectation, not just an efficiency play: EDA inspections and EGAC assessments increasingly look for controlled, audit-trailed quality records.
CORPEX Informatics is an Egyptian company, headquartered in the New Administrative Capital, that develops and deploys eQMS for regulated organisations across Egypt and the wider MENA region. CORPEX pairs an enterprise-grade, FDA 21 CFR Part 11-ready platform with what the global vendors cannot offer Egyptian teams: Arabic-language support, on-site implementation, and contracts and pricing in Egyptian Pounds.
Why Egyptian Companies Are Moving to an Electronic QMS
Three pressures are pushing Egyptian organisations off paper quality systems:
- EDA data-integrity scrutiny. Egyptian Drug Authority inspections focus on ALCOA+ data integrity and on whether quality records are controlled — paper logs and uncontrolled spreadsheets are where findings originate.
- ISO 9001 & EGAC accreditation. Certification and accreditation both require demonstrable control of documents, records, corrective actions and competence — exactly what an eQMS enforces by design.
- Export & partner audits. Companies serving multinational customers or export markets are held to FDA 21 CFR Part 11 and EU Annex 11 for electronic records — a bar a validated eQMS is built to clear.
Why Egyptian Companies Choose a Local QMS Vendor
Global QMS platforms are powerful, but they are priced, supported and documented for large multinationals. Here is where a local partner makes the difference.
Arabic & English
Bilingual interface and an Arabic-speaking implementation and support team, so QA staff, document owners and EDA/EGAC auditors all work in the language they know best.
Egyptian Pound Pricing
Quotes, licensing and support in EGP, scoped for small and mid-sized Egyptian companies — not per-seat dollar licences built for global enterprises.
On-Site in Egypt
On-site configuration, validation, data migration and staff training in Cairo, the New Capital and across Egypt — not just remote tickets.
Built for EDA & ISO 9001
Controlled documents, audit trails and e-signatures designed around EDA GMP, ISO 9001 and EGAC ISO/IEC 17025, aligned with FDA 21 CFR Part 11 and EU Annex 11.
Connects to LIMS & ERP
Deviations, OOS results, CAPAs and change controls flow between quality, laboratory (LIMS) and enterprise (ERP) systems without re-keying.
A Vendor You Can Visit
A local team in the same time zone that can be on-site for go-live, audits and troubleshooting — the partnership Egyptian QA managers rely on.
One Integrated Quality System
Every module shares the same records, so a deviation can raise a CAPA, a CAPA can trigger a change control, and a change can update a controlled document — without leaving the system.
Document Control
Controlled creation, review, approval and versioning of SOPs and quality documents with full history.
Corrective Actions
Root-cause investigation, corrective and preventive actions, and effectiveness checks, tracked to closure.
Deviation Management
Log, classify and investigate deviations and non-conformances with linked CAPAs and approvals.
Change Control
Assess, approve and implement changes with risk evaluation and full traceability.
Audit Management
Plan, schedule and conduct internal and supplier audits with findings routed to CAPA.
Training Management
Assign, track and evidence training and competency, linked to document and role changes.
Risk Management
Structured risk assessment and mitigation tracking across quality processes.
Supplier Quality
Qualify, evaluate and monitor suppliers, with linked audits, complaints and CAPAs.
Complaints Handling
Capture, investigate and close customer complaints with regulatory traceability.
ISO 9001, EDA GMP, EGAC and 21 CFR Part 11
Egyptian organisations sit under several overlapping quality expectations at once. A single eQMS is what lets one system answer to all of them:
- ISO 9001 — control of documents, records, corrective action and competence, enforced by the system rather than by procedure alone.
- Egyptian Drug Authority (EDA) GMP — controlled quality records and ALCOA+ data integrity for pharmaceutical manufacturing and QC.
- EGAC ISO/IEC 17025 — quality-system requirements for accredited testing laboratories.
- FDA 21 CFR Part 11 & EU Annex 11 — electronic records and signatures for export and partner audits, with tamper-evident audit trails.
Deploying a new eQMS is itself a computerised system that regulators expect to be validated — CORPEX delivers that with local computer system validation (CSV) services in Egypt.
QMS Implementation in Egypt: What to Expect
A focused eQMS rollout is configuration and change management, not just installation. Here is how a CORPEX project is phased.
Assessment & Design
We map your quality processes, document set and regulatory scope (ISO 9001, EDA, EGAC, export), then produce the configuration design and validation plan.
Configure & Migrate
The system is configured to your workflows, existing documents are migrated under control, and your team is trained in Arabic and English.
Validate & Go-Live
We execute validation, hand over the documentation, and support go-live so you are inspection-ready from day one.
Built for Egyptian Industry Leaders
CORPEX solutions 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 CORPEX understands the quality documentation an EGAC assessor expects and the records an EDA inspection scrutinises.
Ready to Digitise Your Quality System?
Talk to a local CORPEX specialist about an eQMS configured for your organisation, your compliance obligations and your budget — in Arabic or English.
Request a ConsultationQMS Software in Egypt — Frequently Asked Questions
Is there a QMS software vendor based in Egypt?
Yes. CORPEX Informatics is an Egyptian company headquartered in the New Administrative Capital that builds and implements an electronic QMS (eQMS) for pharmaceutical, food and manufacturing organisations across Egypt and the MENA region — with Arabic-language support, on-site implementation, and contracts in Egyptian Pounds.
What modules does CORPEX eQMS include?
The full quality system: document control, CAPA, deviation and non-conformance management, change control, audit management, training management, risk management, supplier quality, complaints handling, management review, and KPIs and analytics — integrated so a finding in one module flows into the next.
Which standards does CORPEX eQMS support?
ISO 9001 quality management, EDA GMP, EGAC ISO/IEC 17025 for laboratories, and electronic-record requirements under FDA 21 CFR Part 11 and EU Annex 11, with audit trails, electronic signatures and ALCOA+ data-integrity controls built in.
Does CORPEX eQMS support Arabic?
Yes. It is delivered with bilingual Arabic and English support, including an Arabic-speaking implementation and support team, so QA staff, document owners and auditors work in the language they know best.
Can CORPEX eQMS connect to our LIMS and ERP?
Yes. It integrates with CORPEX LIMS and with third-party LIMS and ERP systems, so deviations, out-of-specification results, CAPAs and change controls flow between quality, laboratory and enterprise systems without re-keying. Each integration is scoped during implementation.
How does an eQMS help with EDA and EGAC readiness?
It replaces paper logs and spreadsheets with controlled, audit-trailed records, so the document control, CAPA, deviation and training evidence an EDA inspector or EGAC assessor asks for is already on file and retrievable — shortening inspection prep from weeks of binder-building to a few controlled reports.
How much does QMS software cost in Egypt?
It depends on the number of users, the modules deployed and the deployment model (on-premise or cloud). As a local vendor, CORPEX quotes and contracts in Egyptian Pounds and scopes to small and mid-sized Egyptian organisations — typically more cost-effective than per-seat licences from global QMS vendors. Contact CORPEX for a quote.