Commissioning and Qualification
Optimizing people, processes and timelines to deliver highly successful operations.
Total Commissioning, Qualification and Validation (CQV) solutions for the life sciences industry
Sequence provides comprehensive quality and compliance solutions for our life sciences clients to help them optimize their laboratory, computer systems and manufacturing operations. Using a strategic approach, our consultants utilize technical and operational expertise in process design, engineering, commissioning, qualification and validation to bring projects to life effectively and efficiently.
Areas of Focus
- Biopharmaceutical
- Cell & Gene Therapy
- Laboratories
Engagement Models
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 to help you bring your pharmaceutical products to market on time and on budget.
- We bring lessons learned through our large consulting base of cumulative knowledge and experience together with our understanding of regulatory requirements, combined with critical aspects as it pertains to product quality and patient safety.
- We know how to navigate a project lifecycle while adding value from conceptual design through licensure and beyond.
- Our consultants are cross-functionally trained to support the design and testing of any area within the facility: Manufacturing, Lab, Utilities, Equipment and IT/Computerized Systems.
Project Consulting
Total responsibility for delivering a specified CQV (commissioning, qualification, validation) Scope of Work throughout all stages of the project lifecycle: Strategy > Planning > Execution > Delivery
Managed Services
Shared responsibilities, in partnership with your team, to provide continuous improvement programs that increase operational efficiency.
Specialized Support
Providing individuals to execute specialized tasks under your management.
A PROVEN, SYSTEMATIC PROCESS
Execution of Commissioning, Qualification and Validation Deliverables
To help expedite your project timeline and get your facility production-ready, we offer a science- and risk-based CQV project plan, based on our industry knowledge that includes common project pitfalls and compliance best practices. Our proactive, hands-on approach allows us to anticipate issues before they arise, adjust quickly as project variables change and seamlessly adapt as projects become more complicated along the way. This results in a smoother overall project execution and reduced timeline to turn over a facility fit for intended use that is ready for inspection.
Requirement Definition
Our SMEs use a systematic approach of developing user- and functional- requirement specifications for facilities, utilities, processes, software and systems to ensure key components such as CQAs, CPPs, product knowledge, process knowledge and sequence of operations are defined to reflect desired functionality and intended use.
Design Review
Sequence will perform Design Reviews throughout the project design lifecycle in order to yield the Design Qualification deliverables for Direct Impact systems. Our SMEs perform DR/DQ activities as documented evidence that the design of new equipment and/or software is suitable for intended use.
Strategy & Planning
Whether you need support for an existing facility or a new one, our team of experts can develop and implement strategies to bring the full scope of your manufacturing and engineering project into a compliant state, by utilizing a science and risk-based approach (i.e. ASTM-e2500, ISPE Baseline Guidance, etc.) and quality-by-design concepts. Available strategies include:
- Risk Management (per ICH Q9)
- Science-Based
- Establish CQAs, CPPs, Control Strategies (CDEs), and Critical Aspects via product risk assessments and system risk assessments
- Leveraged Vendor Documentation
- Perform Vendor Assessments
- Continuous Improvement
- Operational and Performance Data (Data Analytics)
- Change Management
- Good Engineering Practice (GEP) – SME Driven
- Data Integrity Assessment/Testing Strategy
- Periodic Review for Established Systems
Planning is critical when performing a risk-based CQV effort. Our team of experts will develop CQV plans (Site Validation Master Plan, Commissioning Plan, IT Validation, Lab Validation, Computer System Validation) based on industry standards and guidelines to cover the following components:
- Documentation Practices (GDP)
- Change Management
- Deviation Management
- System Assessments
- Impact Assessments
- Risk Assessments
- Part 11 Assessments
- Boundary Identification
- Leveraging Strategies
- Vendor Assessments
Testing
We will assist you with the development and execution of deliverables to demonstrate fit for intended use as defined in the specifications. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to provide the framework for reliable and repeatable functionality of manufacturing processes to produce commercial pharmaceutical products as required by the FDA.
Turnover
Our team will help you create the final package needed for turnover, which will include documented evidence of your facility's operation and its preparedness for inspection including all commissioning, qualification and validation documentation.
Service Areas
When starting up a new pharmaceutical manufacturing facility, it's critical to work with the right CQV partner as early as possible. At Sequence, our team of consultants bring comprehensive knowledge of pharmaceutical manufacturing processes to ensure the commissioning and qualification (IQ, OQ and PQ) activities are completed to ensure the facility is fit for intended use and ready for regulatory submissions.
We regularly perform commissioning and qualification for the following systems and areas:
Facilities
- HVAC
- Rooms
- Water systems
- Electrical power and lighting systems
- Fire protection systems
- Waste management systems
- Building security systems
Utilities
- Clean Utilities (Generation & Distribution)
- WFI
- RO
- Compressed Gases
- Clean Steam
- Dirty Utilities
- Water
- Instrument Air
- Compressed Gases
- Waste Systems
Equipment
- 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
Computerized Systems
- Manufacturing execution systems (MES)
- Physical - Sensors, Transmitters, etc.
- Monitoring, Supervision, Discrete Control, Continuous Control, Batch Control (PLC/DCS)
- Enterprise Resource Planning (ERP) - Business Planning and Logistics
- Laboratory Information Management System (LIMS)
- Computerized Maintenance Management Systems (CMMS)
- Quality Management Systems (QMS)
Lab Equipment
- UV-Vis
- Spectrophotometers
- HPLC/UPLC/GC
- TOC Analyzer
- Plate Readers – Nanodrop, qPCR
- BACT/ALERT, VITEK MS, VITEK 2,SCANRDI, BIOFIRE FILMARRAY
- EM Equipment
Clean Rooms and Controlled Environments
- Particulate and microbial controls
- Temperature and humidity control
- Air flow patterns