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Our Services

COmputer system validation (CSV)

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

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  • 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:

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  • 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

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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.

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  • 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

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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:

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  • Data Integrity Risk Assessments

  • GMAP 5-Based RIsk assessments

  • Audit trails, Procedural and Policy Review

  • Gas Analysis, FMEA and Remediation Planning and Implementations

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