At Genesis, we don’t just identify deficiencies, we resolve them. We maximize value by involving industry experts to ensure your facility,
systems and equipment are installed and operating in accordance
with user requirements.
Our approach begins with the end in mind – making sure your building and systems operate properly!
Our building commissioning experts understand all aspects of the project cycle and work with you to develop a commissioning execution plan that meets your needs. We support projects of all different sizes and types including equipment replacements (such as AHUs, chillers, and emergency generators), renovations, building expansions, and new buildings.
Our consists of personnel with backgrounds in engineering and field installation and startup. We have Subject Matter Experts (SMEs) with strong backgrounds in Building Automation Systems (BAS), HVAC systems, testing and balancing, cleanrooms, laboratories, clean utilities, and electrical systems. We support projects with cGMP manufacturing space and equipment, clean utilities (such as WFI and clean steam), cleanrooms, R&D laboratories, warehousing, storage facilities and equipment, offices, healthcare, medical device, higher education, mission critical and central utilities. We can also implement commissioning programs to meet LEED certification.
Our team goes beyond commissioning into qualification and validation. We develop a CQV plans that cover all aspects of facility, utility, and process and laboratory equipment validation. From commissioning of non-GMP systems though full CQV of GMP direct-impact systems that includes integrated commissioning, IQ, OQ and PQ.
The keys to your success are:
• Integrating commissioning into the planning phase and continuing through design, construction, start-up, acceptance, and training
• Applying Good Engineering Practices (GEP) and industry standards such as ISPE, ASHRAE, ISO, and ASTM
• Staffing projects with SMEs as well as MEP and automation system experts who can assess and troubleshoot operation of your facility, utility, and process systems
• Developing test plans with clear and thorough procedures that verify all aspects of installation, operation and performance
• Adding value to the process with a “resolution approach” to not only find issues but to resolve them
We ensure your systems and processes comply with stringent industry regulations, leveraging our expertise in a range of critical service areas:
• Equipment Validation: We perform rigorous validation of your process and laboratory equipment, ensuring it consistently meets the intended specifications and industry requirements, thus enhancing operational efficiency.
• Utility Validation: We specialize in validating utilities such as HVAC systems, water systems, clean gas systems, and steam generators, optimizing their performance within the defined parameters and improving overall process efficiency.
• Facility Validation: Our experts validate cleanrooms, laboratories, and other facility spaces to ensure full compliance with industry standards and guidelines such as ISO-14644, promoting a secure and effective work environment. To meet your compliance needs, we develop and oversee cleanroom certification programs and EMPQ programs.
• Environmental Monitoring Systems (EMS) Validation: We expertly validate your EMS to your technical and operational requirements and in compliance with 21 CFR Part 11, ensuring your system is calibrated and your data is secure.
• Computer System Validation (CSV): To improve data integrity, our CSV team employs agile methodologies in a regulated environment to validate the accuracy, reliability, and consistent performance of your computerized systems.
• Standard Operating Procedures (SOPs): We offer both pre-packaged and tailor-made SOP solutions, ensuring all critical tasks comply with industry best practices and regulatory requirements, thereby improving quality management systems.
We are committed to delivering the highest quality assurance, ensuring regulatory compliance, enhancing operational efficiency, and contributing to your success.
Less -Our retrocommissioning services fine-tune existing buildings and systems to ensure they’re delivering peak performance for energy savings, occupant comfort, and environmental quality.
These services include:
• Condition assessments of existing equipment and systems
• Control sequence review and optimization
• BAS trend log review
• System operational assessments
Our more formal retrocommissioning programs include:
• Investigation: Our team of commissioning engineers survey the installations to make visual observations, assess operational control through field testing and trend log review, review system configuration and design, and compile a report with observations for find and fix issues and potential Energy Conservation Measures (ECMs).
• Implementation: We support the design of any chosen ECMs and the installation or system modifications.
• Verification: After all ECMs are implemented and find and fix issues are resolved, we verify the systems are performing to meet the expected criteria.
Our retrocommissioning services can be tailored to meet your needs.
The purpose of temperature mapping is to ensure and prove that a temperature-controlled space is suitable for its intended purpose.
We offer comprehensive temperature mapping solutions that align with FDA, WHO, ISPE, and GxP Standards, to help you identify and resolve any temperature-related issues in your facility. Our team uses calibrated NIST traceable equipment to conduct thorough temperature mapping of your storage and handling areas, providing you with detailed reports and recommendations for improvement.
Our comprehensive solutions ensure tbat your storage and processing environments meet the highest industry standards:
• Ambient Warehouse: Our experts conduct extensive temperature mapping of your warehouse facilities, ensuring compliance with storage guidelines and optimizing inventory management.
• Cold Chain: We specialize in providing reliable temperature mapping solutions for your cold chain logistics, ensuring product integrity from origin.
Our highly skilled professionals augment your existing workforce, ensuring seamless project execution, and compliance with industry regulations:
• Commissioning Support: We assist in the commissioning process, helping to verify and document the installation and functionality of equipment and systems.
• Qualification Expertise: We ensure that your facilities, utilities, and equipment meet the necessary standards and perform reliably.
• Validation Professionals: We employ industry best practices and regulatory guidelines to execute validation activities, ensuring the accuracy, consistency, and compliance of your processes and systems.
• Regulatory Compliance: Our services align with the requirements of regulatory bodies, such as the FDA, to help meet and maintain compliance
• Industry Knowledge: Our team stays up to date with the latest trends, guidelines, and best practices, including those from respected organizations such as ISPE (International Society for Pharmaceutical Engineering) and ASTM International.
With our services, you gain access to a pool of skilled professionals who can seamlessly integrate into your project teams, providing the expertise necessary to achieve regulatory compliance, operational excellence, and project success.
Less -We use a quality-based process for evaluating building enclosure components to improve operational efficiency, enhance systems performance, and extend the facilities’ lifespan. We integrate our services within the design and construction phases to ensure alignment with owner requirements, and if desired, help you obtain “Enhanced System Commissioning” credit in the LEED rating system.
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