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THE S4 COMPLIANCE PROCESS

SIMPLE, SYSTEMATIC, SUSTAINABLE, SCALEABLE

 

FOR QUALITY SYSTEMS COMPLIANCE AND

SYSTEMS ENGINEERING

Good Quality System design builds on the requirements and intentions of the regulations, then adapts those

requirements and intentions to the company, processes, operations and culture in which the system must function.  

A good Quality System is enforced, but never force-fit.  Not if the goal is long-term compliance and success.

AccuReg's S4 Compliance Process (Simple, Systematic, Sustainable, Scaleable)

works for you because it works with you.

 

Developed in the field by Dr. Loui Silvestri and his team as a targeted, comprehensive compliance approach to

wide-reaching, systemic Quality System challenges, the tried and proven S4 approach offers lasting solutions scaled to efficiently address root cause issues. Our S4 Process can be applied to full Quality Systems

or to individual Quality System processes and components, including:

  • Quality Systems design, including comprehensive Quality Master Plans

  • Corrective and Preventive Action (CAPA) systems - automated, manual or hybrid

  • Complaint handling systems - automated, manual or hybrid

  • Comprehensive documentation and record-keeping systems

  • Individual compliance documents, including Master Batch Records (MBRs), Device Master Records (DMRs), Device History Records (DHRs), Design History Files (DHFs), Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), and more

  • Master validation plans, programs, protocols, procedures and control forms

  • Validation and qualification (IQ/OQ/PQ/PPQ) of equipment, processes, facilities, test methods and software/computer systems

  • Equipment relocation and re-qualification

  • Process automation and control

  • Process analysis and methods improvement

  • Production equipment and software procurement

  • Business process re-engineering (BPR)

  • Training programs (GMP, GCP, QS Regulation and ISO) for personnel at all levels

  • Post-marketing regulatory support such as:

    • Medical device tracking requirements
    • Medical device design control processes

    • MDRs, Corrections and Removals reporting

    • Pharmaceuticals and biologics adverse event reporting

AccuReg FDA Regulatory & Compliance Consulting, Quality Systems