Why Choose Facilities Consulting NW?
Whether you’re building a new facility, expanding an existing one, or simply seeking to optimize your operations, we provide comprehensive solutions to help you achieve your goals.
Avoid Costly Delays & Redesigns
We integrate critical compliance factors from the outset, ensuring your facility is planned with precision and meets all regulatory requirements.
Unparalleled Expertise
Our team of experienced professionals possesses deep knowledge of GMP regulations and industry best practices.
Holistic Approach
We offer a comprehensive suite of services, from initial planning to ongoing support, ensuring your facility’s success.
Client-Centric Focus
We prioritize your needs and goals, providing personalized guidance and support throughout the entire process.
Streamline Your Facility Projects with FCNW
01
Discovery
We begin with a detailed understanding of your goals and requirements.
02
Customized Plan
We develop a tailored strategy to meet your specific needs.
03
Implementation & Support
We manage the process from design to execution, ensuring compliance and efficiency.
01
Discovery
We begin with a detailed understanding of your goals and requirements.
02
Customized Plan
We develop a tailored strategy to meet your specific needs.
03
Implementation & Support
We manage the process from design to execution, ensuring compliance and efficiency.
Facility Design Consulting
From Concept to Completion
Ensure regulatory compliance, maximize efficiency, and achieve a smooth operational launch with our comprehensive facility design consulting services. We guide you through every stage of your facility’s lifecycle, from planning to ongoing operations.
Avoid costly redesigns and permit resubmissions by integrating critical compliance factors from the outset of your facility design. Our approach ensures that every aspect of your facility is planned with precision, incorporating essential elements that enhance functionality and ensure regulatory compliance.
Project Management
Streamlined Efficiency, Seamless Execution
Focus on what matters most while we handle the complexities of your project. We offer a collaborative and results-oriented approach that prioritizes efficiency and minimizes risks.
We act as your dedicated project consultant, representing your interests throughout the project to ensure that the project stays on track and meets all GMP and business requirements.
Project Planning & Design
We work with you from the inception of your project, helping to develop a clear and comprehensive project plan. Our planning process ensures that all aspects of your project are thoroughly considered and accounted for.
Design Analysis & Value Engineering
Our team conducts detailed design analysis to identify opportunities for cost savings and operational efficiency. Through this process, we help you optimize your project to ensure the highest return on investment without compromising on quality or compliance.
Construction Support
During the construction phase, we oversee the project to ensure that it is executed according to plan. This includes coordinating site visits, inspections, and ensuring that all construction activities comply with GMP standards and other regulatory requirements.
Risk Management
We identify potential risks early in the project and develop mitigation strategies. This includes conducting risk assessments, developing contingency plans, and ensuring all project activities adhere to safety and compliance standards.
Commissioning (CxA) & Start-Up Support
The commissioning process ensures all systems and equipment are installed and functioning as intended. Our start-up support ensures a smooth transition to full operations.
Project Planning & Design
We work with you from the inception of your project, helping to develop a clear and comprehensive project plan. Our planning process ensures that all aspects of your project are thoroughly considered and accounted for.
Design Analysis & Value Engineering
Our team conducts detailed design analysis to identify opportunities for cost savings and operational efficiency. Through this process, we help you optimize your project to ensure the highest return on investment without compromising on quality or compliance.
Construction Support
During the construction phase, we oversee the project to ensure that it is executed according to plan. This includes coordinating site visits, inspections, and ensuring that all construction activities comply with GMP standards and other regulatory requirements.
Risk Management
We identify potential risks early in the project and develop mitigation strategies. This includes conducting risk assessments, developing contingency plans, and ensuring all project activities adhere to safety and compliance standards.
Commissioning (CxA) & Start-Up Support
The commissioning process ensures all systems and equipment are installed and functioning as intended. Our start-up support ensures a smooth transition to full operations.
GMP Quality Systems
Your Roadmap to Quality & Compliance
Navigate the ever-evolving world of GMP regulations with confidence. Our comprehensive GMP Quality Systems service provides a clear path to achieving and maintaining the highest quality and compliance standards.
Quality Assurance + GMP Audits
Prepared for FDA, NSF, and TGA audits and maintained continuous compliance with detailed Quality Management Systems (QMS) gap assessments, supplier audits, and other consulting services.
Validated Systems Solutions
Ensuring that your systems are adequately validated is crucial for GMP compliance. We provide facility and equipment qualification solutions (DQ/IQ/OQ) that meet GMP standards, ensuring your facilities operate smoothly and efficiently.
Contamination Control Strategies
We employ effective contamination control strategies to eliminate risks, safeguarding your operations, and ensuring product safety.
Personnel & Process Flow Optimization
Optimizing personnel and process flows enhances efficiency and compliance. Our experts design layouts that maximize capacity, streamline operations, and minimize contamination risks.
Quality Assurance + GMP Audits
Prepared for FDA, NSF, and TGA audits and maintained continuous compliance with detailed Quality Management Systems (QMS) gap assessments, supplier audits, and other consulting services.
Validated Systems Solutions
Ensuring that your systems are adequately validated is crucial for GMP compliance. We provide facility and equipment qualification solutions (DQ/IQ/OQ) that meet GMP standards, ensuring your facilities operate smoothly and efficiently.
Contamination Control Strategies
We employ effective contamination control strategies to eliminate risks, safeguard your operations, and ensure product safety.
Personnel & Process Flow Optimization
Optimizing personnel and process flows enhances efficiency and compliance. Our experts design layouts that maximize capacity, streamline operations, and minimize contamination risks.
Make Your Facility Future-Ready
We are ready to provide tailored solutions for your facility needs, ensuring you stay ahead of the competition with compliant, reliable, and profitable operations.
FAQ
Our industry experts are well versed in all relevant FDA, NSF, and TGA regulations including: 21 CFR Part 11, 21 CFR 110, 21 CFR 111, 21 CFR Part 117, 21 CFR Part 210, FSMA, NSF 173, NSF/ANSI 455-2, and TGA PE009.
We ensure ongoing GMP compliance through comprehensive services including GAP audits, validation and qualification protocols, SOP development, staff training, and regular operational reviews. Our expertise helps identify potential compliance issues early and implement effective solutions to maintain the highest standards of GMP compliance throughout your facility's operations.
Yes. We conduct GAP audits, provide operational reviews, develop SOPs, and offer training to ensure ongoing GMP compliance. Our goal is to help you maintain and improve your facility's compliance, reliability, and efficiency.
Absolutely! If you already have facility designs, FCNW can conduct a thorough review to ensure they comply with GMP standards. We will assess the designs, identify any potential compliance issues, and provide recommendations for adjustments to meet regulatory requirements.
No. Facilities Consulting NW provides technical reviews and consulting for facility design but does not offer professional design services directly. We work closely with architects and engineers to ensure that your facility design meets all GMP compliance requirements.
If you do not have a design team, we can help you find qualified professionals to collaborate with on your project.
Yes. We offer post-project support to address any issues that may arise and to ensure that your facility continues to operate efficiently and in compliance with GMP standards.
If you do not have a design team, we can help you find qualified professionals to collaborate with on your project.
The typical project timeline varies based on the scope and complexity of the project. The design, planning, and implementation phases can range from a few months to over a year, depending on the project's size and specific needs.
During the proposal stage, we provide a customized approximate timeline to help you clearly understand the expected duration.