Part 11 Compliance Considerations for SCADA Systems

Supervisory Control and Data Acquisition (SCADA) systems are tremendous assets in the pharmaceutical, medical device, and other FDA regulated manufacturing industries, providing cost efficiencies and improving the consistency of product quality. They have also enabled the industries to move from hardcopy to electronic production records. Systems used for manufacturing pharmaceuticals, medical devices, and other regulated health care products must comply with current Good Manufacturing Practices (cGMP). Production related electronic records are subject to compliance with the same predicate rules (e.g. 21 CFR Part 211 and 21 CFR Part 820) that would apply under paper-based quality systems. In addition, the systems that produce and retain these records are required to comply with 21 CFR Part 11 rules for electronic records and signatures.

SCADA system records and functions that are subject to 21 CFR Part 11:

• User access security restriction
• Electronic signatures
• Graphical user interface (GUI) displays, operator entries, and controls
• Recipe creation, editing, and version control
• Recipe sequence enforcement
• Electronic logging of recipe procedures executed by system with time-stamped audit trails
• Data collection, storage, protection, audit trails, and retrieval.
• Production data historian with audit trails and reports
• SOP’s for life-cycle management

Functional Specifications for new systems must include 21 CFR Part 11-related requirements, and qualification testing must clearly challenge and document them.

Production data is acquired primarily from manufacturing equipment instrumentation via process logic controllers, as well as operator workstations and interfaced peripherals such as barcode readers. Production data is also generated in the form of batch identification and target parameters from the recipe and batch databases. Interfacing manufacturing execution systems (MES), and enterprise resource planning systems (ERP) may also provide data for the batch record. Each data parameter value within the electronic batch record must be traceable back to its specific source, and it must be linked to its production batch identifier. All critical data collection functions must be qualified to ensure the integrity of the data acquired by the SCADA software system and stored in the resulting electronic batch records.

Loss of critical data associated with a lot or batch can result in the loss of product. Data security and automated periodic or real-time backups of production data should be implemented to prevent data loss. Historical production records must remain accessible and readable throughout the lifecycle of the system or the record retention period required by regulation, whichever comes first. Finally, all data records must be comprehensive, complete, bound to their associated records, and easily retrievable for audit by the FDA.

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