Commissioning and Validation

When you need to verify the performance of your facility and manufacturing systems, or validate equipment, our commissioning and validation team will ensure all standards are met through a comprehensive assessment and assist in planning corrective actions if necessary.

Our commissioning and validation process focuses on the key areas: performance, staff training, and engineering documentation. We provide documented evidence that equipment, software, and instruments are fit for use and consistently perform as expected. Our processes ensure this performance can be reliably repeated as specified.

Our qualification services are delivered to FDA-regulated Life Sciences research and manufacturing sites. As a Principal Commissioning Agent, we can also assist you in reaching LEED Certification for your facility at any level.

Commissioning and validation are typically the final steps before project completion. Our mission is to ensure that all problems are resolved, training is complete, systems are operational, and maintenance personnel are equipped to keep the systems operating reliably and efficiently. We deliver consistency by standardizing our deliverables and ensure quality by providing our expertise, vast experience, and continuous professional development.

SYSTEMS & FACILITIES COMMISSIONING

RETRO - COMMISSIONING

SYSTEMS VALIDATION

CHANGE MANAGEMENT

SYSTEMS AND FACILITIES COMMISSIONING

We utilize our specialized engineering and controls integration expertise. We partner with clients to provide long-term support and continuous improvement.

Our commissioning services include:

HVAC and Control Systems
Electrical Power Distribution
Lighting
Life Safety Systems
Ultrapure and Clean Systems
Renewable Energy Systems
Building Envelope

SYSTEMS VALIDATION

Our GMP validation services ensure that equipment, software, and instruments used in pharmaceutical, biologic, and medical device manufacturing meet your specifications, are fit for use, and deliver repeatable functionality. We provide thorough testing, documentation of system and facility fitness, and resolve any issues that arise.

Our system validation services include:

Pharmaceutical Equipment and Utilities Validation
Laboratory Instrumentation Validation
Computer System Validation
Computer Software Assurance
Regulatory Compliance
Automated System Validation
Equipment and Instrument Validation

CHANGE MANAGEMENT AND ISSUE RESOLUTION

Our professionals are skilled in change management, process improvement, and failure investigations, including FDA 483 observations. When you have an issue with quality, we are here. We partner with our clients to provide long-term support and continuous improvement.

Our change management services include:

Corrective Action
Preventative Action
Documentation & training

Ensuring Consistency and Reliability

By standardizing our work products and deliverables we guarantees that our services meet the stringent requirements of GMP regulations. We centralize all commissioning and validation documents and reports, making them instantly available to all project stakeholders.

Commissioning with Future in Mind

We partner with our clients to provide long-term support and continuous improvement. Our commitment extends beyond project completion, ensuring sustained success and compliance. Our team collaborates closely on-site with the system owner, construction manager, and sub-contractors, building lasting relationships that lead to future collaborations.

Nimble Solutions for Any Location

Our deep technical knowledge equips us to handle projects of varying complexity both large and small. With eight locations across the country, we provide the nimble ability to respond quickly, ensuring timely, high-quality delivery and support wherever your project is located.

Specialized Expertise Integration

Our project teams can engage in-house specialized engineering and control integration experts, ensuring that all aspects of commissioning and validation are handled with precision and professionalism.

CASE STUDY

Commissioning and Qualification

FM Global Commissioning TGMS Sensidyne system

CASE STUDY

Sensidyne Gas System Commissioning

CASE STUDY

Environmental Sustainability Laboratory Commissioning

CASE STUDY

Laboratory For Integrated Science & Engineering (LISE) Commissioning

CASE STUDY

Center for Nanotechnology Commissioning

CASE STUDY

Commissioning and MEP Engineering Consulting

CASE STUDY

Sterilization Facility Commissioning

WHITE PAPER - Commissioning and V-model

Download

GUIDE - Ensuring Proper Operating Sequences and Other Lessons Learned

Download

“Employees are very knowledgeable, respectful, and collaborate effectively with members of a project team.”

- QA Validation Manager, Biotechnology Manufacturer

“Great people and able to meet demands.”

- Automation Engineer, Biotechnology Manufacturer

“I've been impressed with the thoroughness of your testing abilities, the quickness in which you pick up on process knowledge, your commitment to work safely, and the commitment to quality and closure that you have shown. Please keep up the great work!”

- Project Manager, Life Sciences Client

“My experience working with Hallam Engineers is that they are very friendly, knowledgeable, and responsive to their customers needs.”

- Food and Beverage Manufacturer

“Everyone at Hallam is very good at explaining the reason behind decisions and taking the appropriate time to make sure it is understood.”

- Higher Education Professional

“Team players, great problem solvers.”

- Architect

“I'm continually impressed by everyone I've met and worked with on the Hallam team. It's a pleasure to have such trust in a consultant. Thank you for all you do!”

- Architect

Whether you are a life sciences company, a university or industrial plant, our tailored approach ensures that our solutions are perfectly aligned with your unique requirements and timeline. At Hallam-ICS, our approach is rooted in a culture that values collaboration, meticulous attention to detail, and an unwavering commitment to safety. Our team’s engineering expertise and ability to tailor our services to different industries and needs sets us apart, making us a trusted partner in achieving your operational goals.

We follow our proprietary CODES™ process—COMMUNICATIONS, OVERSIGHT, DOCUMENTATION, EXPECTATIONS, and SCHEDULE—to deliver exceptional project quality and consistency. Each project starts with a comprehensive discovery phase, when we gather critical information about your needs and milestones to develop a customized project plan that ensures seamless execution. Throughout the project, we maintain open lines of communication and provide detailed documentation, ensuring that every phase is meticulously managed. Our commitment to technical excellence, combined with our robust customer service, guarantees a successful project outcome and an exceptional customer experience.

How to Properly Decommission a cGMP System in Compliance with FDA

May 29, 2025 4 min read

Why Ongoing Commissioning is the Key to Long-Term Building Efficiency

February 3, 2025 5 min read

The Role of the Commissioning Authority: Who They Are, Why They Matter

January 2, 2025 5 min read

COMMISSIONING AND VALIDATION

ENSURING SYSTEMS ARE OPERATING RELIABLY AND EFFICIENTLY