A LIMS for labs that answer to the SFDA.

The SFDA Guide to Good Manufacturing Practice for Medicinal Products does not name a LIMS. Its Annex 11 applies to all forms of computerised systems used as part of GMP-regulated activities, so a LIMS that holds QC and stability results has to be validated and controlled like any other GMP computerised system. CORPEX LIMS is built for that, and the CORPEX validation team documents it through computer system validation.

Yes. SFDA joined the Pharmaceutical Inspection Co-operation Scheme in 2023 and was the first Arab authority admitted; the PIC/S member list shows accession in July 2023. For a QC laboratory the practical effect is that inspections follow PIC/S-style expectations, including its data integrity guidance (PI 041). CORPEX LIMS is designed around ALCOA+ and PIC/S PI 041. That is our design basis; it is not a statement that SFDA has adopted PI 041.

SFDA's GCC guideline for stability testing (DS-G-005, version 3.4) places the GCC states in climatic zones III and IVa and sets the general-case long-term condition at 30 °C ± 2 °C / 65 % RH ± 5 % RH for 12 months at submission, with accelerated testing at 40 °C ± 2 °C / 75 % RH ± 5 % RH for 6 months. Zone IVb (30 °C / 75 % RH) is not the GCC condition. In CORPEX LIMS the zone and condition table is editable master data, so your regulatory team sets it to the current SFDA document.

Annex 11 in the SFDA GMP guide asks that, based on a risk assessment, the system record all GMP-relevant changes and deletions, that a reason is documented for a change or deletion of GMP-relevant data, and that the audit trail is available, convertible to an intelligible form and regularly reviewed. CORPEX LIMS writes a hash-chained audit trail with user, time, old and new value and reason, shows it read-only, and can verify the chain on demand.

CORPEX LIMS is installed on the customer's own servers or private cloud, so you choose where the data sits, including inside Saudi Arabia. A LIMS holds some personal data, such as user accounts, signatures and audit entries. SDAIA's Regulation on Personal Data Transfer Outside the Kingdom sets conditions for moving personal data out of the Kingdom, and the Personal Data Protection Law is the legal frame. Hosting in-Kingdom is a deployment fact, not a legal certification; take advice from your own counsel on what applies to you.

Partly. The application shell, navigation, sign-in page and in-app help are available in Arabic with right-to-left layout. The working screens (samples, worksheets, investigations, stability) are in English today. If your analysts need those screens in Arabic, ask us at the demo what that would involve.

SAAC (Saudi Accreditation Center) accredits testing and calibration laboratories against ISO/IEC 17025. A LIMS does not make a lab accredited. CORPEX LIMS supplies controls an assessor looks for: analyst qualification checked before work is allocated, calibration status on every instrument, validated methods, an analyst who cannot review their own result, with review and approval as separate electronic signatures, and a traceable record behind every certificate.

CORPEX Informatics is based in the New Capital, Egypt, and serves the region. There is no Saudi office. You can book a demo online, or meet us in Riyadh during CPHI Middle East (26 to 28 April 2027).