Manufacturing and Facility Validation

Whether you are building a new facility or expanding to your existing operations; installing new capital equipment; re-validating existing equipment/utilities or you have been challenged with compliance deficiencies with your manufacturing operations/equipment, facility, or utility, turn to the experts at Regulatory Compliance Associates® Inc. We can develop and tailor the appropriate facility validation program to help.


Manufacturing Support


RCA can assist with the entire validation life cycle continuum—starting with the validation strategy / validation master plan through purchase, qualification, and commissioning. We have validation experts that can help and guide you from design qualification, and user requirement definition through factory / site acceptance and through commissioning and qualification.


  • Our service solutions include:
  • User requirement specification (URS)
  • Factory acceptance test (FAT)
  • Site acceptance test (SAT)
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Process qualification (PQ)


Expertise in validation of:


  • Equipment
  • Facilities
  • Utilities
  • Computer systems
  • Controls supporting the areas of:
    • Manufacturing
    • Laboratory
    • Utilities
    • Processes
  • Facility validation of existing equipment and operations to stay in compliance
  • Remediation of quality system deficiencies:
    • Manufacturing process
    • Laboratory
    • Equipment
    • Facility


About Regulatory Compliance Associates


Regulatory Compliance Associates (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:



We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.


As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.


  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021


About Sotera Health


The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.


Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.



To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 



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