Compliance

A system for Quality Assurance and Regulatory Affairs (QA/RA) is intended to improve effectiveness of operations, and not a burden or drag to efficiency. QA/RA requirements are seamlessly blended using our strengths in process engineering, performance management systems, information systems, and Quality Systems.

  • Process and quality compliance
  • Electronic inspection records
  • Data reporting using SAP Crystal Reports
  • System control plan development
  • Failure modes and effects analysis (FMEA) 
  • Equipment and process validation
  • ISO 9000
  • 21 CFR 211 cGMP
  • 21 CFR 820 QSR
  • 45 CFR 164 Security & Privacy

Effectiveness

Overall company performance and efficiency is driven by a streamlined strategic focus and structure. A clear understanding of the strategic cascade of business processes, performance standards, and responsibilities outlines the framework for success.​

  • Corporate strategic planning.
  • Business process mapping.
  • Business and operational intelligence.
  • Decision support systems.
  • Objective performance management systems.
  • Pay-for-performance system.
  • Data retrieval, reporting, and score boarding.

​Manage initiatives with precision by deploying a highly disciplined project evaluation and review technique, coupled with Applied IE's broad knowledge of business and operations management systems.

Efficiency

The fundamentals of industrial engineering have been the envy and foundation for process improvement program such as lean, six sigma, and the Toyota production system. Industrial engineering methods, coupled with innovative Applied IE expertise and technology enable us to quickly implement practical solutions that increase effectiveness and efficiency.

  • Motion, methods and time measurement.
  • Facility, line, and workstation layout.
  • Flow and throughput analysis.
  • Workload balancing and process optimization.
  • Kanban: Visual inventory management.
  • Management support staff and operational team structure.
  • Alfred4™ - Paperless computer system and electronic records.