What We Do

Assess, Develop, Test, Implement = Results

Malcom has developed a proven approach, methodology, industry documentation and workflow "best practices". We assess, develop, test, and implement cGMP or EBR/MES solutions with achievable, measurable, and tangible results, on-time and on-budget.

Solutions:

  • cGMP Documentation/Workflow
  • Electronic Batch Records (EBR)/Manufacturing Execution System (MES)
  • Malcom professionals don't sit in an office all day. We spend time where the process happens and where the documentation is executed. This is how we gain first-hand knowledge to quickly address your business needs and interact with our clients on all levels to improve their current systems such as:

    Documentation that: CAPA certification
    • "fits" the process
    • Improves "right first time"
    • Reduces human error
    • Reduces deviations
    • Simplifies integration to EBR/MES
    "Best Practice" Guidance Document that: cGMP
    • Defines documentation "Best Practices"
    • Outlines rules/requirements
    • Improves workflow & content
    • Improves process understanding
    • Addresses regulatory commitments
    Eliminating EBR implementation
    • Redundancy
    • Waste
    • Unnecessary entries/data
    • Excessive checks
    • Satellite forms
    Reducing Cycle Times for: Electronic Batch Record
    • Batch Record Review
    • Lot Release
    • Investigations
    • Document creation/revision
    • EBR/MES Implementation

    Results