Pharmaceutical Software Solutions
Integrated pharmaceutical software for manufacturing and QC — LIMS, electronic QMS, ERP, regulatory affairs and computer system validation — built for compliance with EDA GMP, EGAC ISO/IEC 17025, FDA 21 CFR Part 11 and EU Annex 11.
One Integrated Pharmaceutical Software Platform
Running a pharmaceutical or biotechnology operation means keeping laboratory data, quality processes, regulatory dossiers and manufacturing all under control at once — and proving it to an inspector on demand. CORPEX gives pharmaceutical manufacturers a single, integrated software platform that connects the QC laboratory (LIMS), the quality management system (eQMS), regulatory affairs (RDX), and the enterprise (ERP), so data flows without re-keying and the audit trail is complete end to end.
CORPEX Informatics is an Egyptian company headquartered in the New Administrative Capital, and its pharmaceutical software is used by leading Egyptian manufacturers — including Marcyrl, ATCO Pharma, October Pharma and Orchidia — as well as the Egyptian Drug Authority (EDA). That means Arabic support, on-site implementation, and a system designed around the EDA GMP and EGAC ISO/IEC 17025 requirements an Egyptian pharma company actually faces, while still meeting the FDA 21 CFR Part 11 and EU Annex 11 standards that export markets demand.
Research and Development
RENOVA RDX is a Modern integrated platform for pharmaceutical R&D and Regulatory affair. Renova RDX helps manufacturers maximize operational efficiency while assuring compliance with both internal corporate and external regulatory standards. It is a fully scalable system designed for organizations of any size. Task management gives users throughout the facility or organization appropriate access to input and retrieve data from a single, centralized system.
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Regulatory Affairs
Regulatory team should be fully equipped to develop regulatory strategy and manage compliance, risks and dossier submissions across the globe. The regulatory team should leverage the obtained regulatory approvals to penetrate new markets quickly and cost effectively. Regulatory module organizes archiving and management system for CTD files, clinical studies, regulatory approvals, bioequivalent studies, submissions, comments, licences, requests, naming, pricing, scientific files, product master files in addition to any important documents.
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Quality Control
Silver-LIMS is integrated platform that will efficiently assist organizations manage their incoming raw materials, in-process, and finish goods from initial registration of the material to its final product. Silver LIMS helps manufacturers maximize operational efficiency while assuring compliance with both internal corporate and external regulatory standards. Silver LIMS organizes QC laboratory data and documentation activities such as Methods of analysis (SOPs), Certificate of analysis (COA) of finished products, bulk, raw and package materials, Product specifications, Annual product review, Statistical Process control, standard materials and laboratory instruments.
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Quality Assurance
CORPEX-DC solution simplifies the management of all documents, from automating key processes such as revision tracking to exceeding compliance requirements. Store all of your organization's documents in one secure, centralized system and implement consistent, companywide document workflow processes. Easily locate documents using intelligent, global search capabilities that leverage metadata to locate assets with as little as a single word of text.
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Microbiology
MicroLIMS is an innovative microbiology laboratory solution empowers microbiological examinations like test suitability, growth promotion tests (GPT), Microbiological Limits tests (MLT), Antibiotic bioassay, Sterility tests, Bacterial endotoxins, preservative and disinfectant efficacy test are included. Common laboratory activities like media preparations, reference strains and stock control in addition to assets and instrument logs. Control of samples that are out of specifications (OOS) are conducted.
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ERP
In today's dynamic and competitive business landscape, the need for robust and streamlined Enterprise Resource Planning (ERP) systems has never been more critical. Corpex-ERP stands at the forefront of innovation, offering a comprehensive solution that transcends traditional ERP capabilities.
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Built for Pharmaceutical Compliance
Pharmaceutical software is only useful if it stands up to inspection. Every CORPEX module is engineered around the standards a pharma manufacturer answers to:
- Egyptian Drug Authority (EDA) GMP — controlled records and ALCOA+ data integrity for manufacturing and QC.
- EGAC ISO/IEC 17025 — accreditation requirements for QC and testing laboratories.
- FDA 21 CFR Part 11 & EU Annex 11 — electronic records and signatures with tamper-evident audit trails for export and partner audits.
- ICH & WHO GMP — stability (ICH Q1A), quality risk management and the guidelines that govern global pharmaceutical quality.
Because deploying regulated software is itself a computerised system that must be validated, CORPEX delivers local computer system validation (CSV) services in Egypt alongside every implementation, so the system is inspection-ready at go-live.
Explore the Pharmaceutical Platform
Each system stands alone or works as one — localised for Egyptian pharma with Arabic support and EGP pricing.
Pharma LIMS
QC sample management, stability (StabLIMS), microbiology (MicroLIMS) and instrument integration for Egyptian pharma labs.
Pharma eQMS
Document control, CAPA, deviations, change control, audits and training in one integrated quality system.
CSV Services
GAMP 5 / CSA computer system validation with full IQ/OQ/PQ documentation, delivered on-site.
Pharmaceutical Software — Frequently Asked Questions
What software does a pharmaceutical company need?
A regulated pharmaceutical operation typically needs a LIMS for QC laboratory data, an electronic QMS for document control, CAPA and change management, a regulatory affairs system for dossiers and submissions, and an ERP for manufacturing and supply. CORPEX provides all four as one integrated platform, so data flows between them without re-keying.
Is CORPEX pharmaceutical software compliant with EDA and 21 CFR Part 11?
Yes. CORPEX software is engineered around Egyptian Drug Authority (EDA) GMP and EGAC ISO/IEC 17025, with electronic records, audit trails and electronic signatures aligned to FDA 21 CFR Part 11 and EU Annex 11 — and CORPEX provides the computer system validation (CSV) evidence to prove it.
Does CORPEX support Arabic and local implementation in Egypt?
Yes. CORPEX is an Egyptian company headquartered in the New Administrative Capital, with Arabic-speaking implementation and support teams, on-site deployment across Egypt, and contracts in Egyptian Pounds.
Can the modules be bought separately or must I take the whole suite?
Modules can be deployed individually — for example LIMS for the QC lab first, then eQMS — or as a full integrated suite. Because they share a common platform, adding a module later connects it to what you already run without a separate integration project.
Which Egyptian pharmaceutical companies use CORPEX?
CORPEX solutions are trusted by leading Egyptian pharmaceutical manufacturers including Marcyrl Pharmaceutical Industries, ATCO Pharma, October Pharma and Orchidia Pharmaceutical Industries, as well as the Egyptian Drug Authority (EDA).
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