Whether you are building a new facility or expansion 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 validation program to help.

 

Manufacturing Support

  • We can assist with the entire validation life cycle continuum—starting with validation strategy / validation master plan through purchase, qualification, and commissioning
  • We have validation experts that can help and guide you from design qualification, user requirement definition through factory / site acceptance and through commissioning and qualification. We have experts in: user requirement specification (URS), factory acceptance test (FAT), site acceptance test (SAT), and installation qualification / operational qualification / process qualification (IQ/OQ/PQ) summary reports
  • Expertise in validation of: equipment, facilities, utilities, computer systems and controls supporting the areas of: manufacturing, laboratory, utilities, and processes
  • Re-validation of existing equipment and operations
  • Remediation of quality system deficiencies related to your laboratory, manufacturing process, equipment, or facility
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