Commissioning, Qualification, and Validation (CQV)

Services - CQV

Our Commissioning, Qualification, and Validation (CQV) services ensure that facilities, systems, and equipment are designed appropriately, function as intended, and work together to produce a safe and effective product.

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.

Biopharmaceutical CQV Expertise

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Commissioning

Our approach begins with the end in mind – ensuring the optimal performance and functionality of your building and systems! We have a comprehensive understanding of the entire project cycle and collaborate with you to create a commissioning execution plan tailored to your specific [...]More +

Our approach begins with the end in mind – ensuring the optimal performance and functionality of your building and systems!

We have a comprehensive understanding of the entire project cycle and collaborate with you to create a commissioning execution plan tailored to your specific requirements. Our expertise extends to projects of varying sizes and types, encompassing equipment replacements (such as AHUs, chillers, and emergency generators), renovations, building expansions, and new construction.

Our team comprises individuals with backgrounds in engineering, field installation, and startup. We have Subject Matter Experts (SMEs) who possess extensive knowledge in Building Automation Systems (BAS), HVAC systems, testing and balancing, cleanrooms, laboratories, clean utilities, and electrical systems. We provide support for projects involving cGMP manufacturing spaces and equipment, clean utilities (such as WFI and clean steam), cleanrooms, R&D laboratories, warehousing, storage facilities and equipment, offices, healthcare, medical devices, higher education, mission-critical facilities, and central utilities. Additionally, we can help you implement commissioning programs to achieve LEED certification.

We go beyond commissioning. We develop comprehensive CQV plans that encompass all aspects of facility, utility, process, and laboratory equipment validation. Our services range from commissioning non-GMP systems to conducting full CQV for GMP direct-impact systems, including integrated commissioning, IQ, OQ, and PQ.

The keys to your success include:

  • Integrating commissioning from the planning phase and continuing throughout design, construction, start-up, acceptance, and training.
  • Applying Good Engineering Practices (GEP) and industry standards such as ISPE, ASHRAE, ISO, and ASTM.
  • Assigning project teams consisting of SMEs, MEP experts, and automation system specialists who can assess and troubleshoot the operation of your facility, utility, and process systems.
  • Developing robust test plans that verify all aspects of installation, operation, and performance.
  • Adding value to the process by adopting a “resolution approach” that not only identifies issues but also provides effective solutions for them.
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Qualification

We ensure your systems and processes comply with stringent industry regulations, leveraging our expertise in a range of critical service areas: Equipment Qualification: We perform rigorous qualification of your process manufacturing and laboratory equipment, ensuring it consistently meets the [...]More +

We ensure your systems and processes comply with stringent industry regulations, leveraging our expertise in a range of critical service areas:

Equipment Qualification: We perform rigorous qualification of your process manufacturing and laboratory equipment, ensuring it consistently meets the intended specifications and industry requirements, thus enhancing operational efficiency.

Utility Qualification: We specialize in qualifying utilities such as water systems, clean gas systems, and steam generators, optimizing their performance within the defined parameters and improving overall process efficiency.

Facility Qualification: Our experts qualify 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 Environmental Monitoring Performance Qualification (EMPQ) programs.

Environmental Monitoring Systems (EMS) Qualification: We expertly qualify 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 dedicated to delivering the highest quality assurance, ensuring regulatory compliance, enhancing operational efficiency, and contributing to your overall success.

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Retrocommissioning

Our retrocommissioning services specialize in optimizing existing buildings and systems to achieve peak performance, resulting in energy savings, improved occupant comfort, and enhanced environmental quality. Our services include: Condition assessments: We thoroughly evaluate existing equipment and [...]More +

Our retrocommissioning services specialize in optimizing existing buildings and systems to achieve peak performance, resulting in energy savings, improved occupant comfort, and enhanced environmental quality.

Our services include:

Condition assessments: We thoroughly evaluate existing equipment and systems to identify any potential areas for improvement.

Control sequence review and optimization: Our experts examine and enhance the control sequences to ensure optimal operation.

BAS trend log review: We analyze the trend logs from the Building Automation System (BAS) to identify trends and patterns for further optimization.

System operational assessments: We assess the overall performance of the systems to identify any operational inefficiencies.

Our formal retrocommissioning programs encompass the following steps:

Investigation: Our experienced commissioning engineers conduct a detailed survey of the installations, making visual observations and performing field tests and trend log reviews. They also review system configuration and design. The findings are compiled into a comprehensive report, highlighting identified issues and suggesting potential Energy Conservation Measures (ECMs).

Implementation: We provide support in designing the chosen ECMs and assist in the installation or modification of systems accordingly.

Verification: Once all ECMs have been implemented, and any identified issues have been addressed, we verify that the systems are performing as expected, meeting the predetermined criteria.

We understand that every project is unique, and we’re dedicated to tailoring our retrocommissioning services to meet your specific requirements and goals.

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Temperature Mapping

The purpose of temperature mapping is to ensure and prove that a temperature-controlled space is suitable for its intended purpose. We offer a range of comprehensive temperature mapping solutions that adhere to industry standards such as FDA, WHO, ISPE, and GxP. These solutions help you identify [...]More +

The purpose of temperature mapping is to ensure and prove that a temperature-controlled space is suitable for its intended purpose.

We offer a range of comprehensive temperature mapping solutions that adhere to industry standards such as FDA, WHO, ISPE, and GxP. These solutions help you identify and address any temperature-related issues within your facility. To ensure accuracy and reliability, our team uses calibrated NIST-traceable equipment during the temperature mapping process. We then provide you with detailed reports and actionable recommendations for improvement based on our findings.

Our comprehensive solutions guarantee that your storage and processing environments meet the highest industry standards. Here are some of our specialties:

Controlled Temperature Units (CTUs):  Our team verifies the consistent temperature control in your refrigerators, freezers, and incubators, safeguarding the quality of stored biological samples and pharmaceutical products.

Autoclaves & Ovens: We provide thorough temperature mapping of autoclaves and ovens, ensuring proper sterilization processes.

Cold Chain: We specialize in providing reliable temperature mapping solutions for your cold chain logistics. With our expertise, we ensure the integrity of your products throughout their journey, starting from the point of origin. This helps to safeguard the quality and efficacy of temperature-sensitive items.

Ambient Warehouse: Our team of experts conducts extensive temperature mapping of your warehouse facilities. By doing so, we ensure compliance with storage guidelines and optimize inventory management to enhance operational efficiency.

We’re dedicated to delivering accurate temperature mapping results and helping you maintain the integrity of your temperature-controlled equipment and spaces.

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CQV Staff Augmentation

Our team enhances your existing workforce, ensuring the smooth execution of projects while adhering to industry regulations. Commissioning Support: We provide assistance throughout the commissioning process, verifying and documenting the installation and functionality of equipment and [...]More +

Our team enhances your existing workforce, ensuring the smooth execution of projects while adhering to industry regulations.

Commissioning Support: We provide assistance throughout the commissioning process, verifying and documenting the installation and functionality of equipment and systems.

Qualification Expertise: We guarantee that your facilities, utilities, and equipment meet the required standards and consistently perform as expected.

Validation Professionals: Following industry best practices and regulatory guidelines, we conduct validation activities to ensure the accuracy, consistency, and compliance of your processes and systems.

Regulatory Compliance: Our services are designed to align with the stringent requirements of regulatory bodies, including the FDA, helping you meet and maintain compliance.

Industry Knowledge: Our team stays updated 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 talented pool of professionals who seamlessly integrate into your project teams, providing the expertise necessary to achieve regulatory compliance, operational excellence, and project success.

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Building Enclosure Commissioning

Building Enclosure Commissioning (BECx) ensures the performance, integrity, and durability of a building’s envelope. Our Building Enclosure Commissioning process involves a meticulous and systematic approach to evaluating and verifying the performance of the building envelope. We work closely [...]More +

Building Enclosure Commissioning (BECx) ensures the performance, integrity, and durability of a building’s envelope.

Our Building Enclosure Commissioning process involves a meticulous and systematic approach to evaluating and verifying the performance of the building envelope. We work closely with architects, engineers, and contractors to ensure that the enclosure systems meet design intent, industry standards, and regulatory requirements.

Our services encompass various stages of the construction process, including design review, construction observation, and performance testing. We thoroughly assess the key elements of the building enclosure, such as roofs, walls, windows, doors, and sealants, to identify any deficiencies or vulnerabilities.

Through diagnostic testing, we evaluate factors such as air leakage, water penetration, thermal performance, and structural integrity. We use state-of-the-art equipment and industry-approved testing methods to obtain accurate and reliable data.

Based on the findings, we provide detailed reports and recommendations to address any identified issues. Our expertise enables us to propose effective solutions that enhance the performance and sustainability of the building enclosure

By implementing Building Enclosure Commissioning, you can mitigate risks associated with moisture intrusion, air leakage, energy loss, and potential structural problems. Our services not only help you meet regulatory requirements but also contribute to long-term cost savings, improved building durability, improved energy efficiency, and enhanced occupant satisfaction.

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