Regulatory Compliance Associates® Inc. can help with remediation activities in the areas of manufacturing operations and quality systems. We have completed many projects assisting our clients to evaluate what is needed, collaboratively determine action plans and provide assistance to execute. We have also performed post-implementation audits to ensure effectiveness of improvements.

 

RCA can assist you and your organization in:

 

  • Auditing capabilities to understand and verify if there is a gap in compliance within manufacturing operations and any Quality area
  • Developing specific strategies and defining tactical actions for current good manufacturing practice (cGMP) areas to regain compliance with U.S. and other regulated bodies
  • Guiding and leading implementation for improvement efforts in:
    • Manufacturing shop floor production
    • Quality systems: quality control, quality assurance, document control, investigations, and corrective and preventive actions (CAPAs), batch record review and release
    • Supporting departments and activities: preventative maintenance / calibration, warehousing, vendor auditing, etc.
  • Performing oversight activities for manufacturing / production and quality control (QC) testing

 

At RCA, we tailor-make a specific solution to fit your organization’s need.

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