11-4-730, Chilkalguda, Secunderabad, Telangana
Service Detail
Qualification and Validation
- Ensures that all equipment and systems meet defined requirements.
- Verifies performance, functionality, and compliance with industry standards.
- Aims for full stakeholder acceptance by delivering validated solutions.
- Risk Assessment: Identifies potential failures and their impact.
- Gap Analysis: Compares existing systems against regulatory requirements.
- Mitigation Plan: Develops corrective actions to address deficiencies.
- Ensures systems meet user and regulatory expectations.
- Covers system testing, validation planning, and compliance documentation.
- Factory Acceptance Testing (FAT): Ensures equipment meets design specifications before shipment.
- Site Acceptance Testing (SAT): Verifies installation, performance, and integration on-site.
- Confirms that processes consistently meet specifications.
- Includes installation (IQ), operational (OQ), and performance (PQ) qualifications.
- ASTM E2500: Science- and risk-based manufacturing qualification.
- ICH Q9: Structured approach to quality risk management in pharmaceuticals.
- Ensures smooth transition from commissioning to full-scale operation.
- Includes functional testing, troubleshooting, and operator training.
- Ensures IT and automated systems function correctly and securely.
- Complies with FDA 21 CFR Part 11, GxP, and ISO regulations.
- Maintains validation records, risk assessments, and compliance reports.
- Ensures audit readiness with organized documentation.
