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Services

Commissioning, Qualification & Validation (CQV)

Services

Commissioning, Qualification & Validation (CQV)

Our extensive knowledge and years of experience across the life sciences industry work as an insurance policy for your project execution. Whether you partner with us for your entire commissioning, qualification and validation project scope or require a more specialized solution, we offer proven strategies to help you achieve and maintain operational readiness that will bring your pharmaceutical products to market on time and on budget.

Commissioning, qualification and validation strategies + experience to help you reach goals faster

Our extensive knowledge and years of experience across the life sciences industry work as an insurance policy for your project execution. Whether you partner with us for your entire commissioning, qualification and validation project scope or require a more specialized solution, we offer proven strategies to help you achieve and maintain operational readiness that will bring your pharmaceutical products to market on time and on budget.

Hands-on Learning Makes a Difference

Manufacturing Area

Utilities Area

Analytical Lab

Microbiology Lab

Networking

Digital Solutions

Lecture Room

Warehouse

Personnel and Material Flow

Manufacturing Area

Program Covington: Automation & MES CQV Commissioning, Qualification and Verification

Project Basecamp: Lab Instrument Qualification

A proven, systematic process

Commissioning, qualification and validation strategies + experience to help you reach goals faster

Our extensive knowledge and years of experience across the life sciences industry work as an insurance policy for your project execution. Whether you partner with us for your entire commissioning, qualification and validation project scope or require a more specialized solution, we offer proven strategies to help you achieve and maintain operational readiness that will bring your pharmaceutical products to market on time and on budget.

  • User Requirements Specifications (URS)
  • Functional and Design Specifications (FS/DS)
  • Risk Assessments
  • Commissioning Protocols
  • Checklists for mechanical completion
  • Instrument calibration checks
  • Wiring continuity/loop checks
  • Basic operational checks (e.g., pump starts)
  • Qualification protocols
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation protocols
  • For processes, cleaning and computer systems
  • Protocol execution
  • Traceable and controlled:
  • Performed by trained personnel
  • Real-time data recording
  • Documentation of any deviations with impact assessments
  • Final review by Quality Assurance
  • Good Documentation Practices (GDP):
  • Legible, accurate, contemporaneous, original, attributable (ALCOA principles)
  • Deviation resolution and impact assessment
  • Final report generation, summarizing:
  • Test outcomes
  • Deviations and corrective actions
  • Conclusion on system or process suitability
  • Archiving of all records in compliance with regulatory and internal requirements
  • HVAC
  • Rooms
  • Water systems
  • Electrical power and lighting systems
  • Fire protection systems
  • Waste management systems
  • Building security systems
  • Clean Utilities (Generation & Distribution)
  • WFI
  • RO
  • Compressed Gases
  • Clean Steam
  • Dirty Utilities
  • Water
  • Instrument Air
  • Compressed Gases
  • Waste Systems
  • Manufacturing and packaging equipment
  • Process utilities (e.g., steam, compressed air, process water)
  • Laboratory equipment
  • Cleaning systems
  • Buffer Vessels
  • Upstream Equipment
  • Bioreactors
  • Fermentation
  • Downstream Equipment
  • Chromatography
  • Filtration
  • Formulation
  • Fill/Finish
  • Packaging
  • UV-Vis
  • Spectrophotometers
  • HPLC/UPLC/GC
  • TOC Analyzer
  • Plate Readers – Nanodrop, qPCR
  • BACT/ALERT, VITEK MS, VITEK 2,SCANRDI, BIOFIRE FILMARRAY
  • EM Equipment
  • Particulate and microbial controls
  • Temperature and humidity control
  • Air flow patterns
  • Data sheet and submittal reviews
  • Instrument classification
  • Instrument Criticality Assessments
  • Instrument installation
  • Wiring/loop diagram walkdowns
  • Loop checks
  • Calibration certification
  • Water Systems
  • Purified Water (PW)
  • Water for injection (WFI)
  • Clean Steam
  • Compressed Air and Process Gases
  • Clean compressed air
  • Nitrogen (N2)
  • Oxygen (O2)
  • Carbon Dioxide (CO2)
  • HVAC Systems
  • Cleanroom Air Handling Units (AHUs)
  • Pressure differentials, HEPA filtration, Air change rates
  • CIP and Sterilization
  • CIP
  • SIP
  • Autoclaves
  • Sterilizing Filters and Filter Integrity Testing
  • Lyophilizers (Freeze Dryers)
  • Filling and Packaging Lines
  • Process Equipment
  • QC Lab – Analytical Instruments
  • HPLC
  • GC
  • UV/Vis
  • TOC Analyzers
  • pH meters
  • Microbiology Lab – Microbial methods
  • Sterility Testing Systems
  • Endotoxin Detection Systems
  • Bioburden Testing Systems
  • Mixing Tanks/Reactors
  • Filling Lines (Vials, Syringes, bottles)
  • Pumps, Hoses, Piping, etc

A PROVEN, SYSTEMATIC PROCESS

ENGINEERING

Project Management

Startup

Process Engineering

Automation Engineering

Instrumentation & Controls

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How can Sequence support your project success?

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Tulip

No Code App Development for Manufacturing Operations

Tulip creates user-friendly and functional apps that improve the productivity of operations, without writing any code. Users can start from scratch or customize an App Template to fit their needs.

Sequence partners with Tulip for implementation and validation of the Tulip platform as well as creation, configuration and validation of Tulip Applications that are hosted on the platform. Our application builds include Electronic Batch Records, Weigh and Dispense, Digital SOPs for training (with embedded videos) and more.

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