COMMISSIONING AND QUALIFICATION

COMMISSIONING AND QUALIFICATION

Commissioning has become an essential step to insure building systems are installed and operating properly, according to the design intent, before the building is occupied. In regulated industries like the pharmaceutical, biotechnology, and medical device industries, Commissioning and Qualification activities are the foundation for achieving regulatory compliance and for moving into the Process Validation stage. A well-planned and well-executed Commissioning and Qualification effort will accelerate the operation and production activities of the facility, leading to the ultimate goal of producing a marketable product.

Experience

IES is a proven leader in supporting technology-driven facilities achieve successful operation and regulatory compliance by providing tailored C&Q support. Our team has the experience and technical knowledge to execute the most complex, demanding projects due to our combined experience in design, operations, energy efficiency, construction quality, risk management and safety requirements. We work with you throughout the full project lifecycle to insure your objectives are met.

Knowledge

IES is an engineering firm as well as a Commissioning and Qualification services provider. We offer design services for several market sectors, including biopharma, medical devices, and microelectronics. Our team’s knowledge and understanding of technology driven processes allow us to identify potential issues early on that may affect commissioning and qualification later in the project—which can translate into a valuable savings of both time and money.

Innovation

Innovative solutions are crucial to a successful project. Our team includes process engineers with experience in pharmaceutical and biotechnology as well as technical staff that have specialized experience in building systems. Our innovative services are tailored to each client, which can provide our clients with a competitive advantage—especially for facilities that include pilot plants and/or process equipment.

Commissioning Services

Develop commissioning plans that support the overall project schedule

Owner Project Requirements (OPR) and Design Reviews

Commissioning schedule integrated with construction

Participation in the RFI process

Pre-functional checklists and Functional Performance Tests

LEED Enhanced Commissioning

Review of contractor training plans

Conduct Seasonal Testing

Develop Systems Manuals

Preparation of final commissioning reports

Execution of commissioning activities to allow leveraging into qualification activities

Qualification Support

User Requirement Specifications (URS)

System Requirement Specifications (SRS)

Validation Master Plans (VMP)

Standard Operating Procedures (SOP)

Impact Assessments (IA)

Factory Acceptance Testing (FAT)

Site Acceptance Testing (SAT)

IQ, OQ, and PQ protocol development and execution

Schedule integration

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