🔒 Validation & Compliance Ecosystem

📋 CSV – Computer System Validation

Purpose: Establishes the foundational validation protocol ensuring that computerized systems meet user requirements and comply with regulatory expectations throughout their entire lifecycle.

The Three Qualification Pillars:

Installation Qualification (IQ): Verifies that all hardware, software, and network components are installed correctly and meet specifications. Confirms that the system’s physical infrastructure is sound.

Operational Qualification (OQ): Demonstrates that the system operates as intended under normal operating conditions. Tests control logic, alarms, data integrity, user access, and all critical functions including Part 11 compliance (electronic signatures and audit trails).

Performance Qualification (PQ): Validates system performance with real or simulated product over an extended period (minimum 30 days). Confirms that validated parameters produce consistent, acceptable results.

Regulatory Alignment:

CSV is the primary mechanism for demonstrating compliance with 21 CFR Part 11 (electronic records/signatures), EU Annex 11 (computerized systems), and GAMP 5 (validation framework). It provides the documented evidence that your system is fit for purpose.

🔄 CSA – Computerized System Assurance

Purpose: Provides continuous, risk-based assurance that computerized systems remain in a validated state throughout their operational lifecycle, with proactive identification and management of compliance risks.

Core CSA Activities:

Periodic System Reviews (PSR): Typically annual, these reviews assess system performance, deviation trends, change impact, audit trail completeness, and data integrity. The risk-based approach determines whether full revalidation is needed or if focused testing suffices.

Deviation Management: When deviations occur (failures, unexpected results), CSA determines root cause and whether the deviation indicates loss of validated state. CAPA is implemented with verification and closure documented.

Change Control: CSA assesses the regulatory impact of any change. Minor changes (e.g., screen layout) may need only documentation; major changes (control logic, database structure) may trigger revalidation.

The CSA-CSV Connection:

CSA uses CSV-established baselines as the reference point. If CSA detects drift from validated parameters, it recommends revalidation (a new CSV exercise) or control implementation to restore compliance. This bidirectional relationship keeps systems compliant indefinitely.

⚙️ SCADA – Supervisory Control & Data Acquisition

Purpose: Provides real-time monitoring and control of manufacturing processes, acquiring sensor data, executing control logic, managing alarms, and maintaining data logs with integrity controls.

Critical Functions (All Must Be Validated):

Data Acquisition: SCADA reads sensor inputs (temperature, pressure, flow, pH) at defined intervals. Data is time-stamped and logged with attribution (which sensor, which equipment).

Control Logic: Based on sensor inputs, SCADA executes predefined control logic (e.g., “if temp > 75°C, reduce heater power by 20%”). This logic MUST be validated in CSV OQ to ensure process safety.

Alarm Management: When parameters exceed setpoints, SCADA triggers alarms. Operator response is logged. Alarm effectiveness is critical—missed alarms = undetected process excursions = batch failure potential.

Data Logging & Integrity: SCADA stores all data in validated databases with redundancy/backup. Data cannot be edited post-collection (write-once). Audit trails record all access and modifications by operators/administrators.

In CSV/CSA Context:

SCADA is the operational workhorse. CSV establishes SCADA’s validated state (IQ/OQ/PQ). CSA monitors SCADA performance, validates that logged data matches sensor readings, and verifies alarm effectiveness. SCADA’s audit trail provides much of the evidence for CSA periodic reviews.

👥 HMI – Human-Machine Interface

Purpose: Provides the validated operator interface for interacting with SCADA systems, displaying real-time process data, executing commands, and maintaining audit trail records in compliance with 21 CFR Part 11.

21 CFR Part 11 Compliance Mechanisms:

Electronic Signatures: Instead of paper signatures, HMI implements electronic signatures (combination of password + biometric or badge). The signature legally binds the operator to any action taken (approvals, data entry, parameter changes).

Audit Trails: Every operator action is logged with timestamp, user ID, action type, data before/after change, and context. This creates an unbreakable record of “who did what, when, and why.”

User Access Control: HMI enforces role-based permissions. A Line Operator might only VIEW process data, while a Supervisor can MODIFY setpoints. Access is tied to unique user IDs—no shared logins.

Data Display Validation: The data shown on HMI screens must accurately reflect SCADA source data. Misalignment = regulatory violation. CSV OQ validates that screen values match SCADA values in real-time.

In CSV/CSA Context:

HMI is where operators interface with the validated system. CSV tests that screens are accurate, signatures work, and audit trails capture all actions. CSA spot-checks audit trails to confirm ongoing Part 11 compliance. HMI audit trails provide much of the evidence for data integrity audits.