Qualification & Validation Services
Ensuring Compliance, Performance, and Operational Excellence. At GMC Cx, we provide industry-leading Qualification and Validation (Q&V) services to ensure that your systems, processes, and facilities meet regulatory standards and operate at peak performance. Our expert team specializes in Commissioning, Qualification, and Validation (CQV) for pharmaceutical, biotechnology, medical device, and life sciences industries, helping you achieve compliance with FDA, EU GMP, MHRA, WHO, and other global regulatory bodies.
Equipment Qualification (IQ, OQ, PQ)
We ensure that your critical equipment and systems are installed, operated, and performing as per predefined specifications through a structured qualification approach:
Installation Qualification (IQ)
Verifying proper installation according to manufacturer recommendations and regulatory guidelines.
Operational Qualification (OQ)
Confirming that equipment operates within defined limits under test conditions.
Performance Qualification (PQ)
Ensuring equipment consistently performs as intended in real-world production conditions.
Process Validation
We deliver end-to-end process validation services to confirm that your manufacturing processes are reproducible, robust, and compliant with cGMP standards. Our process validation includes:
Process Design
Process Qualification
Continued Process Verification
Facility & Utility Qualification
We qualify critical utilities and controlled environments to meet GMP standards, including:
Water and Gas Systems
Compressed and Gas Systems
Cleanrooms and Controlled Areas
Environmental Monitoring System (EMS)
Qualification
Solvent Delivery Systems (SDS) andSolvent Waste Systems
Autoclaves and Glasswashers (maybe there is a more general word for these)
Cold Storage Units (CSU) and walk-in cold rooms and freezer rooms.
Risk-Based Approach to Qualification & Validation
Our CQV experts use a science- and risk-based approach to focus on critical quality attributes (CQAs) and critical process parameters (CPPs), ensuring cost-effective and efficient validation strategies aligned with the latest ICH Q9 and ASTM E2500 guidelines.
Why Choose GMC Cx?
Regulatory Expertise:
We align with global compliance requirements, including FDA, EU GMP, and ISO standards.
Customized Solutions:
Our tailored validation programs fit your unique operational needs.
End-to-End Support:
From risk assessment to full lifecycle validation, we ensure your systems are audit-ready.
Industry Experience:
A team of experienced validation engineers, CQV specialists, and GMP consultants.
Lean commissioning and qualification programs based on ASTM e2500
User Requirement Specifications (URS)
Commissioning and Qualification Strategy
Failure Mode and Effect Analysis (FMEA)
Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
P&ID walk-downs and verification of system drawings as required.
Writing reports to summarize validation/verification/ commissioning and/or revalidation/verification commissioning activities.
Investigating abnormal testing results.
Preparation and execution of leverageable commissioning protocols including Installation Verification, (IV), Operational Verification (OV) and Integrated Systems Testing (IST).
Validation Master Plan and Project Plans (VMP)
Functional Requirements Specification (FRS)
Risk Assessment (RA) and System Impact Assessments (SIA)
Standard Operating Procedure (SOP) development for both operation and maintenance programs
Trace Matrices.
Standard Operating Procedure (SOP) development for both operation and maintenance programs
Writing procedures, investigations, protocols, change controls, etc. to support the maintenance and engineering departments.
Troubleshooting CQV problems.
Protocols including Installation and Operational Qualification (IOQ) and Performance Qualification (PQ).
WHERE WE WORK
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Mission Critical Data Centers
Telecommunications
Laboratories
Pharmaceutical
Manufacturing
Healthcare & OSHPD
Hospitality & Gaming
Office – Low and High Ris
Mixed-Use Facilities
High-rise Residential
Institutional
Government Facilities
COMMISSIONING
COMPLIANCE
LEED Fundamental
LEED Enhanced Cx
Title-24 Commissioning
CalGreen Commissioning
Local Energy Code Regulations
CGMP Cx and Qualification
Uptime Institute Level 1 – 5 Cx
SYSTEMS WE
COMMISSION
Mechanical
Electrical
Emergency Power Systems
Low Voltage
Lighting and Lighting
Renewable Energy and Water
Plumbing
Process and Utilities
Controls & Automation
Assemblies
SYSTEMS WE
COMMISSION (CONT.)
Building Enclosures
Microgrids
IT
Clean Rooms
Lab Exhaust & Fume Hoods
Fire Alarm
Security
AV
Environmentally Controlled Rooms
EXISTING BUILDING COMMISSIONING
Existing-Building-Commission.jpg Existing building commissioning Existing Building Commissioning (EBCx) is a systematic process for planning, assessing, investigating, analyzing, improving, optimizing and verifying the performance of building systems and assemblies.
OTHER SERVICES
SPECIALTY SERVICES
As a value add to our core commissioning services, we provide enhanced testing and certifications including IR Scanning, Building Envelope Commissioning (BECx) and Indoor Air Quality (IAQ) testing.
ANALYTICS
The MBCx process has been shown to reduce energy waste by 30%. The benefits of MBCx include transparency, increased energy efficiency and more precise operation by ensuring the building meets or exceeds its planned utility consumption.