Pharmaceutical Manufacturing


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 Consultant Services & 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

Connect with RCA Today

Contact us to learn more about our regulatory compliance experts and how they can help

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