Commissioning, Qualification, & Validation
Commissioning, Qualification, and Validation (CQV) form an integrated framework ensuring that every facility — whether pharmaceutical, healthcare, industrial, laboratory, or commercial — operates reliably and in full compliance with global standards.
At Bonafide HVAC, we implement systematic CQV processes that verify performance, safety, and efficiency, ensuring each system functions exactly as intended across diverse industries.
Precision Management of Scope, Schedule, and Resources
At Bonafide Solutions, we specialize in project scope, timelines, and resources to ensure controlled changes, reduce risks, and keep your project aligned with strategic goals. Our disciplined approach drives consistent success in delivering complex facility projects across pharmaceutical, healthcare, industrial, and commercial sectors.
COMMISSIONING
Systematic testing and verification of equipment and systems to ensure they are installed and function according to design specifications, enabling safe and efficient facility startup.
QUALIFICATION
Structured processes to confirm that critical systems, equipment, and processes operate consistently and meet predetermined performance criteria under real-world conditions.
VALIDATION
Comprehensive documentation and testing to demonstrate that the facility and systems consistently produce reliable, compliant, and high-quality outcomes as required by industry regulations.
Managing Scope, Schedule, and Resources
Managing scope, schedule, and resources ensures controlled change, minimizes risks, aligns goals, and drives consistent project success across industries.
COMMISSIONING
Ensuring that systems are designed, installed and perform as intended
QUALIFICATION
Confirming that systems meet their requirements and specifications
VALIDATION
Documenting evidence that systems consistently produce the desired results
Ensuring accuracy, reliability, and Global Compliance at every stage
Our Comprehensive Validation Framework (CVF) is designed to guarantee that every process, system, and outcome meets the highest standards of quality, security, and global compliance. Through systematic validation steps, we help organizations build trust, reduce risks, and achieve operational excellence.
Commissioning & Validation Master Plans (CVMPs)
The CVMP acts as the roadmap for all validation activities, defining scope, responsibilities, and regulatory requirements. It aligns stakeholders and ensures clarity from the start.
Process Validation (PV)
Process Validation confirms that manufacturing processes consistently deliver quality products. Covering design, qualification, and ongoing verification, it ensures every batch meets global compliance standards.
Protocol Development & Execution
Structured protocols (DQ, IQ, OQ, PQ, Cleaning) provide step-by-step validation. This ensures traceability, audit readiness, and regulatory global compliance at every stage.
Complete System Validation
Beyond individual equipment, we validate the entire system—facilities, utilities, computerized systems, and operations—ensuring end-to-end reliability and performance.
Engineering-Driven, Best Practices & Risk-Based Approach
Bonafide applies engineering principles and risk-based strategies to streamline Commissioning, Qualification and Validation, reducing costs, accelerating timelines, and ensuring best practices global compliance with global pharmaceutical and biotech standards.
Engineering-Driven, Risk-Based Approach
We apply rigorous enginerring principles and structured risk assessments to identify critical systems early. This ensures testing activities are meaningful, targeted, and aligned with ASTM E2500 and other global best practices.
Optimized Cost Efficiency
Our approach eliminates unnecessary documentation and redundant testing, streamlining processes without sacrificing quality. By focusing only on value-adding tasks, we deliver significant cost savings across the project lifecycle.
Accelerated Project Delivery
With streamlined Commissioning and Qualification workflows, we minimize delays and maximize productivity. This acceleration helps you achieve regulatory approval and get your facility operational faster—giving you a competitive edge.
Trusted Technical Expertise
Our highly skilled engineers and consultants bring deep industry experience to every project. From planning to execution, you benefit from hands-on guidance, clear strategies, and seamless delivery.
Resource Optimization
We focus your resources where they matter most—on critical quality attributes and performance factors. This ensures smarter allocation of time, manpower, and capital investment for maximum impact.
Global Compliance Assurance
Every step of our process is designed to meet international regulatory standards (FDA, EMA, ISPE, ICH, ASTM). With bonafide, global compliance isn’t just achieved—it’s assured.
Best Practices
Industry best practises and innovations, and feedback loops to continuously refine our processes—delivering ever-better performance, higher quality, and greater value over time.
