Device Inspection System (Vision/Microscopy) – Equipment Validation SOP

Standard Operating Procedure for Device Inspection System Validation

Purpose: This SOP outlines the validation process for the Device Inspection System used in the inspection of coating defects and dimensions of drug-eluting stents and coated devices.

Scope: This procedure applies to the Quality Control (QC) and Research & Development (R&D) areas involved in the validation of the Device Inspection System.

Definitions:

  • DQ: Design Qualification
  • IQ: Installation Qualification
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • CSV: Computer System Validation

Roles:

  • Validation Team: Responsible for executing the validation activities.
  • Quality Assurance: Ensures compliance with regulatory requirements.
  • Equipment Owner: Responsible for maintaining the equipment.

Lifecycle Procedure:

  1. Design Qualification (DQ) – Establish user requirements and specifications.
  2. Installation Qualification (IQ) – Verify that the system is installed correctly.
  3. Operational Qualification (OQ) – Validate the system’s operational capabilities.
  4. Performance Qualification (PQ) – Confirm the system’s performance meets specifications.

GDP Controls: Good Documentation Practices must be adhered to throughout the validation process to ensure traceability and compliance.

Acceptance Criteria Governance: Acceptance criteria shall be governed by the User Requirement Specification (URS) and Annex 11 compliance.

Calibration/PM Governance: The Device Inspection System must be calibrated and maintained according to the manufacturer’s specifications and internal calibration schedules.

Change Control Triggers: Any modifications to the Device Inspection System or its operational procedures must undergo a formal change control process.

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Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or when significant changes occur that may impact the system’s performance.

Records/Attachments List:

  • Validation Protocols
  • Validation Reports
  • Calibration Certificates
  • Change Control Records
  • Periodic Review Documentation

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