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Our Work

Commissioning & Qualification Support for Complex, Regulated Manufacturing Programs

We support life sciences and regulated manufacturers with execution-focused CQV services across multi-site programs, greenfield builds, expansions, and beyond.

Due to client confidentiality agreements, some details are anonymized.

Supported multiple facilities across the U.S.

GMP / GxP-ready deliverables

From commissioning to final qualification

Working alongside Engineering, Quality, and Operations

Supporting manufacturers from greenfield startup through operational stabilization.

Recent CQV
Engagements

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Examples of recent commissioning and qualification work.

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BioTech Facility - Qualifications and Start-Up Management March 2026 - Present Supported greenfield construction of a new biotech manufacturing facility, providing commissioning, qualification, and validation (CQV) support during start-up activities. Responsibilities included protocol development and execution, as well as troubleshooting and plant punch-list support. Location: Muskegon, Michigan

Life Science Facility – Cleaning Qualifications June 2025 - February 2026 Path Forward performed cleaning qualification services for newly installed COP parts washers at a life sciences facility. Path Forward assisted the client by rendering the following services: • Supported on-site engineering team with process development activities • Determined COP wash configurations • Established cleaning parameters • Defined time, temperature, and concentration parameters • Developed and executed over 2,000 pages of IQ and OQ qualification protocols, that included complex swabbing regimens to document successful program operation and cleaning. Location: Logan, Utah

BioTech Facility – Qualifications & Start-Up Management January 2023 - February 2026 Path Forward Consulting LLC performed qualification and start-up services for a greenfield biotech facility. This multi-year project involved commissioning, qualification, and startup of both liquid processing and powder handling/blending equipment. Services rendered included: • Development and execution of over 5000 pages of IQ and OQ qualification protocols. • Supporting onsite engineering team with process development activities. • Managing the development and implementation of enterprise asset management for entire facility • Development and implementation of PM program for all newly installed equipment • Development and implementation of spare parts program for all newly installed equipment Location: Northern Utah

Life Science Facility – New Equipment Installations, Plant Expansion October 2025 - Present Path Forward supported a life sciences manufacturing facility during a plant expansion and installation of new production equipment. Services rendered included: • Development and execution of Installation Qualifications (IQ) • Development and execution of Operational Qualifications (OQ) • Asset architecture development • Development and integration of maintenance plans • Development, purchasing, and integration of spare parts Location: Pensacola, Florida

Installation Qualification Hardware May 2025 Path Forward Consulting LLC partnered with a nationally recognized construction firm within the food and beverage industry to provide P&ID and valve tag hardware support during plant renovations. Services supported installation documentation and equipment traceability throughout ongoing upgrades. Location: Wisconsin

Life Sciences Facility – Qualifications & Start-Up Management January 2023 - March 2023 Path Forward Consulting LLC performed qualification and start-up services for a life sciences manufacturing facility. This project involved extensive work within highly regulated cleanroom environments and required close coordination with engineering and operations teams. Location: Logan, Utah

Manufacturing Facility – Development of Commissioning Program July 2023 - September 2023 Path Forward developed a formal commissioning program for the facilities engineering team of a manufacturing center. The program was designed to support the startup and management of non-process related utilities and building systems. The program was modeled such that it was compliant with ANSI / ASHRAE / IES Standard 202-2018, The Commissioning Process for Buildings and Systems. Location: Logan, Utah

Life Sciences Facility – CQV Coaching & Development Program July 2023 Path Forward partnered with the manufacturing and facilities engineering departments of a cell culture media manufacturing facility to deliver in-person CQV training. The training focused on the principles of the IQ/OQ/PQ process and improving qualification protocol development. Emphasis was placed on developing documentation that can withstand both customer and regulatory audits. Location: Utah

Manufacturing Facility – CQV Coaching & Development Program January 2025 Path Forward Consulting LLC partnered with the engineering department of a manufacturing company to deliver virtual CQV training. The training focused on the application of equipment qualification principles outside of FDA-regulated industries. The course emphasized how CQV principles can be applied to engineered products across multiple manufacturing sectors, not just food & beverage, medical device, or pharmaceutical environments. Location: Vermont

Infant Nutrition Facility – CQV Plan Development November 2024 - December 2024 Path Forward Consulting LLC developed a comprehensive CQV plan for the installation of multiple pieces of packaging equipment within a manufacturing facility. Services rendered included development of a structured CQV plan to support qualification planning and execution. Location: Vermont

BioTech Facility – CMMS Integration and Management [April 2026 - Current] Provided dedicated support for the implementation of a CMMS program at a new biotech manufacturing facility with multiple work centers. Supported system integration efforts and coordination across functional areas to ensure successful deployment. Services rendered included: CMMS implementation support; system integration; asset and work center setup; coordination of manufacturing equipment, process utilities, and non-process utilities. Location: Muskegon, Michigan

Commissioning planning & execution

Turnover/verification packages and traceability support

Stakeholder coordination and schedule support

IQ/OQ/PQ protocol development and execution

Deviation support and documentation remediation

How We Support Projects

Our work typically includes one or more of the following.

Environments We’ve Supported

Experience across highly regulated and hygienic manufacturing environments.

Bioprocessing & Life Sciences Manufacturing

Regulated Food & Beverage Manufacturing

Cleanroom & Controlled Utility Systems

Greenfield Facilities & Expansions

Startup & Operational Readiness Programs

Planning a Build, Expansion, or Qualification Program?

Tell us what you’re building, upgrading, or qualifying — we’ll help you map the fastest path to readiness.

Prefer email or phone? We’re happy to connect directly.

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