{"id":2360,"date":"2026-08-21T13:48:26","date_gmt":"2026-08-21T13:48:26","guid":{"rendered":"https:\/\/www.buffaloextracts.com\/knowledge\/?p=2360"},"modified":"2026-08-21T13:49:34","modified_gmt":"2026-08-21T13:49:34","slug":"eu-gmp-annex-11-scada-extraction-systems","status":"publish","type":"post","link":"https:\/\/www.buffaloextracts.com\/knowledge\/eu-gmp-annex-11-scada-extraction-systems\/","title":{"rendered":"EU GMP Annex 11: What It Means for SCADA-Controlled Extraction Systems"},"content":{"rendered":"

Annex 11 Compliance Is an Ongoing Operational Discipline, Not a One-Time Validation Event<\/strong><\/h2>

EU GMP Annex 11 SCADA extraction compliance is one of the most technical regulatory requirements facing regulated extraction manufacturers that use computerised systems for process control and data recording. Published as part of EU GMP EudraLex Volume 4 Annex 11 Computerised Systems, the guideline establishes the framework for validating, operating, and maintaining any computerised system that is part of a GMP-regulated manufacturing process - including the SCADA systems that control temperature, pressure, and flow parameters in supercritical CO2 and cryo-ethanol extraction equipment.<\/p>

See How Our Extraction Systems<\/a> Can Support Your Process<\/p>

The scope of EU GMP computerised systems extraction is broader than many facilities realise: Annex 11 applies not only to the SCADA system itself, but to every element that relies on it - the instruments that feed it data, the recipe system that drives process parameters, the audit trail that records operator actions, and the data storage systems that protect batch records from loss. GMP Annex 11 extraction system compliance is not achieved once at validation - it is an ongoing operational discipline. This guide explains what Annex 11 requires from SCADA-controlled extraction systems, how computerised system validation (CSV) works in practice, and what the audit trail and data integrity requirements mean for day-to-day operations.<\/p>

What Annex 11 Requires from SCADA in Extraction<\/strong><\/h2>

EU GMP Annex 11 SCADA extraction requirements apply to SCADA systems that perform one or more GMP-regulated functions: controlling process parameters, recording batch data, generating batch records, managing access to GMP functions, or providing the audit trail for operator actions and system events. For supercritical CO2 extraction, a SCADA system typically performs all of these simultaneously: it controls extraction temperature (typically 35\u201380\u00b0C), pressure (typically 100\u2013350 bar), CO2 flow rate, co-solvent delivery, and separator temperature; it records these parameters continuously throughout each batch; it generates the electronic batch record; and it maintains the time-stamped audit trail of every parameter change and operator action.<\/p>

\"Co2<\/a><\/p>

GMP Annex 11 extraction system requirements for SCADA cover: supplier assessment (the SCADA software supplier must be assessed for GMP compliance capability), computerised system validation (the system must be formally validated before GMP use), ongoing operational controls (access management, audit trail monitoring, periodic review), and decommissioning requirements (data must remain accessible and readable for the required retention period after the system is retired).<\/p>

The fundamental distinction that Annex 11 SCADA extraction compliance draws is between validated and non-validated systems: any SCADA system controlling a GMP process parameter or generating a GMP record must be validated. Using a non-validated SCADA system for GMP production - even temporarily - is a fundamental compliance failure and a routine inspection finding. Change control in GMP extraction is also directly connected: any modification to validated SCADA hardware or software must pass through the change control GMP extraction process, with impact assessment determining whether re-qualification testing is required.<\/p>

Computerised System Validation: The CSV Lifecycle<\/strong><\/h3>

Computerised system validation extraction (CSV) is the documented evidence that a SCADA system does what it is designed to do, consistently and correctly, throughout its operational life. CSV extraction GMP Annex 11 follows the ISPE GAMP 5 lifecycle model<\/a>, which Annex 11 formally recognises. The CSV lifecycle for GMP Annex 11 extraction documentation covers:<\/p>