Expert Services

Qualification & Validation Support

Qualification & Validation Support

At AQC, we provide comprehensive Qualification & Validation (Q&V) support to help medical device manufacturers meet stringent regulatory requirements. Our services ensure that your processes, equipment, and systems are fully compliant with industry standards, including FDA, ISO 13485, and EU MDR.

Our Qualification & Validation Services

Process Validation

We conduct thorough validation of manufacturing processes to ensure product consistency and compliance. Our approach includes:

  • Process Design & Risk Assessment
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Continuous Monitoring & Process Improvement

Equipment Qualification

Ensuring that all equipment used in manufacturing meets regulatory standards is critical. Our support includes:

  • Equipment Installation & Commissioning
  • IQ/OQ/PQ Protocol Development & Execution
  • Calibration & Preventive Maintenance Support

Software Validation

With increasing reliance on software-driven systems, we offer validation services for:

  • Manufacturing Execution Systems (MES)
  • Enterprise Resource Planning (ERP) Software
  • Laboratory Information Management Systems (LIMS)
  • Custom-Built Software & Automated Systems

Cleaning & Sterilization Validation

We assist in ensuring that cleaning and sterilization processes meet industry standards by:

  • Developing Cleaning Validation Protocols
  • Conducting Residue & Bioburden Testing
  • Evaluating Sterilization Effectiveness & Compliance

Facility & Utility Qualification

Our expertise covers qualification of controlled environments, ensuring:

  • HVAC, Water & Compressed Air System Compliance
  • Environmental Monitoring & Control
  • Validation of Cleanrooms & Controlled Areas

Regulatory Documentation & Compliance

We provide full documentation support, including:

  • Validation Master Plans (VMP)
  • Protocols & Reports for IQ/OQ/PQ
  • Risk Assessments & Gap Analyses
  • Audit Readiness & Regulatory Submission Support

We at AQC provide Qualifications and Validation guidance services as following:

Qualification:

  • Production Equipment’s
  • HVAC System
  • Water Generation & Distribution System
  • Steam Generation & Distribution System
  • Compressed Air System

Note: AQC can provide the customized template for URS, FAT, SAT, DQ, IQ, OQ, PQ

Validation:

  • Process Validation
  • Cleaning Validation
  • Analytical Method Validation
  • Media Fill Validation
  • Computer System Validation
  • Clean Room Validation
  • Compressed Air Validation
  • Water System Validation
  • Temperature Mapping
  • Sterilization Validation
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

BH-403, Fourth Floor 81 High Street, Business Hub, Sector 81, Faridabad, Haryana 121002, India

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