Our Services

COmputer system validation (CSV)

Ensure 21 CFR Part 11 and GAMP 5 compliances for critical software Systems:

Stand-alone Computer Systems
Analytical Systems
Building Automation System (BAS)
Distributed Control Systems (DCS)
Aseptic Processing Systems
Isolator Technologies.

CQV services for equipment, facility and utility

Comprehensive Qualification for Lab, Process and Production Equipment. End-to-end equipment and facility qualification to support facility readiness:

Cleanrooms Qualification
Water and Gas Distribution Systems
Analytical Instruments
Processing Equipment
Reach-in Storage areas: Cold Rooms, Cold Boxes, Warehouse
CTUs: Autoclave, freezer, Refrigerator, Incubator, Lyophilizer, Ultra-low Freezer
Cryogenic Freezer and Tanks
Product Filling and Packaging Systems
Equipment Calibration

Enviromental monitoring and clean room testing

Equipment Qualification in accordance with ISO 14644 and UPS <1116> and 797/800 standards to ensure cleanroom performance, contamination control, and regulatory compliance.

Cleanrooms, BSCs, HEPA, Pass-Throughs: HEPA integrity testing, Airflow testing, ACH, Air Flow Visualization (AFV), Particulate Monitoring, Pressure differentials, Enviromental Testing
Air Handling Units
Gas Generation and Distribution Systems
Liquid Nitrogen Handling and Distribution Systems

Data Integrity and risk assessments

We offer comprehensive data integrity evaluations and risk assessments designed to detect gaps, prevent breaches, and ensure compliance with 21 CFR, GAMP 5 and GxP requirements. Our service includes:

Data Integrity Risk Assessments
GMAP 5-Based RIsk assessments
Audit trails, Procedural and Policy Review
Gas Analysis, FMEA and Remediation Planning and Implementations