Electronic batch records for Saudi pharmaceutical plants, built for QP release.

The SFDA Guide to Good Manufacturing Practice for Medicinal Products includes an Annex 16, "Qualified Person and Batch Release", which makes the Qualified Person (QP) responsible for confirming that each batch was made and checked in line with Saudi law, the marketing authorisation and GMP. Corpex-EBR records QP certification as its own signature step after QA disposition. Only users with the Qualified Person role can sign it, the certifying person is recorded, and it is refused until QA has completed its disposition.

Yes. Annex 11 in the SFDA GMP guide covers computerised systems. Section 15 says that when a system records certification and batch release, it should allow only Qualified Persons to certify, should identify and record the person certifying, and that this should be done with an electronic signature. Section 8.2 asks that printouts supporting batch release can show whether data changed after the original entry. Corpex-EBR is built to those points; your validation and procedures still decide whether your site complies.

SFDA became a PIC/S Participating Authority on 1 July 2023. For a manufacturer it means SFDA GMP inspections sit inside the same inspection scheme as many European and other regulators, so records are read against familiar expectations: traceable entries, an audit trail that is reviewed, and signatures that cannot be repudiated. Corpex-EBR keeps the audit trail on at all times and cannot be switched off by any user, including administrators.

SFDA GMP v4.4, Chapter 4, says that where a validated process is continuously monitored and controlled, automatically generated reports may be limited to compliance summaries and exception / OOS data reports. Corpex-EBR allows review by exception only when the process is marked validated and continuously monitored; otherwise the reviewer follows the full-review path. In both cases the release gate stays shut while exceptions, deviations, missing signatures or open laboratory investigations remain.

Yes. Corpex-EBR installs on your own servers or private cloud, so batch records, signatures and audit trails can stay on infrastructure you place in Saudi Arabia. Batch records contain operator names, which is personal data under the Saudi Personal Data Protection Law (Royal Decree M/19), which SDAIA administers. Where you transfer data outside the Kingdom is a decision for you and your legal adviser. This is a statement about where the system runs, not a certification.

Chapter 4 of the SFDA GMP guide says batch documentation is kept for one year after expiry of the batch, or at least five years after certification by the Qualified Person, whichever is longer. Corpex-EBR computes the retention date for each batch from its own dates using a per-market rule table, blocks deletion inside the retention window at database level, and supports legal holds.

No, and we do not claim an integration. RSD is SFDA's drug track-and-trace system. According to SFDA, each pack carries a 2D barcode with expiry date, batch number, GTIN and a serial number. That serialisation happens on the packaging line and in the serialisation system. Corpex-EBR can emit batch events as GS1 EPCIS 2.0 events that a serialisation or track-and-trace system can consume. It is the batch record behind the batch number: it holds the executed process, the signatures and the release decision. We can discuss how your serialisation system and the batch record line up for your site.

The screens are in English today. A master batch record version can carry instruction text in additional languages, and a version with a declared language cannot become effective until that language has been approved. We do not offer an Arabic interface, and we say so rather than promise one.