Ensuring Compliance, Accuracy, and Data Integrity

Analytical instruments like HPLC, GC, UV, and FTIR are critical in regulated industries for quality control and analytical testing. Validation ensures these systems generate reliable, compliant, and audit-ready data, meeting FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and USP guidelines.

Key Validation Aspects:

• Installation Qualification (IQ) – Verifies proper setup and configuration
• Operational Qualification (OQ) – Ensures system performance meets specifications
• Performance Qualification (PQ) – Confirms accuracy, precision, and reproducibility
• Data Integrity & Compliance – Validates audit trails, access controls, and electronic records
• Method Validation & Calibration – Ensures analytical accuracy and consistency

Why Validate?

Regulatory Compliance – Avoid non-compliance risks and penalties

Data Integrity – Prevent unauthorized changes and errors

Reliable Analytical Results – Ensure accuracy and reproducibility

SmartSPOC provides end-to-end laboratory system validation to help maintain compliance and ensure precise analytical outcomes.

Ensure your automation systems are compliant, secure, and audit-ready.