Standard Operating Procedure for the Validation of SCADA Systems in Manufacturing

Purpose

This Standard Operating Procedure (SOP) defines the validation process for SCADA systems utilized in manufacturing to ensure compliance with applicable regulatory requirements and to guarantee that the systems perform as intended.

Scope

This SOP applies to the validation of SCADA systems used in the production area, focusing on supervisory control and monitoring functionalities. It covers the entire lifecycle of the system from Design Qualification (DQ) through Performance Qualification (PQ).

Definitions

• SCADA System: Supervisory Control and Data Acquisition system used for monitoring and controlling industrial processes.
• Validation: A documented process that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
• Criticality: The importance of the system in relation to product quality; in this case, classified as critical.
• CSV: Computer System Validation.

Roles

• Validation Team: Responsible for executing the validation activities and documentation.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documents.
• IT Support: Provides technical support and assists in the implementation of validation activities.

Lifecycle Procedure

The validation lifecycle consists of the following phases:

1. Design Qualification (DQ): Document requirements and specifications for the SCADA system.
2. Installation Qualification (IQ): Verify that the system is installed according to specifications.
3. Operational Qualification (OQ): Test the system to ensure it operates within defined limits.
4. Performance Qualification (PQ): Confirm that the system performs effectively in the production environment.

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process to ensure that all records are accurate, complete, and verifiable.

Acceptance Criteria Governance

Acceptance criteria must align with User Requirements Specifications (URS) and comply with Annex 11 and 21 CFR Part 11 regulations to ensure data integrity and security.

Calibration/PM Governance

Calibration and preventive maintenance (PM) must be performed according to the manufacturer’s recommendations and documented in the maintenance logs.

Change Control Triggers

Any changes to the SCADA system, including updates, modifications, or changes in usage, will trigger a change control process, requiring re-evaluation of the validation status.

Revalidation Triggers and Periodic Review

Revalidation is required after any significant change to the system. A periodic review of the system should be conducted at least annually to ensure continued compliance and effectiveness.

Records/Attachments List

• Validation Plan
• Validation Protocols (DQ, IQ, OQ, PQ)
• Change Control Records
• Calibration and Maintenance Logs
• Training Records