Malcom Associates | Getting Started
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How Do We Get Started?

How Do We Get Started?

 

We conduct a Value Assessment to identify opportunities, potential “compliance gaps”, and the justification for the recommended path forward.

 

Examples of what we Assess:

 

  • Compliance and industry “best practice” gaps and the recommended fix
  • Opportunities to reduce human errors.
  • Unnecessary and/or redundant instructions, entries, forms, and data.
  • Work instructions that are incomplete, inadequate or not clearly stated.
  • Inconsistency in how instructions, parameters and specifications are stated within the Batch Record or other documentation/ systems.
  • Integrity of the data.  What is recorded, how is it used
  • Sequence of steps in the Batch Records, SOPs, or workflow do not accurately follow the process, increase cycle times or are not streamlined to meet business demands.
  • Readiness for automated/electronic environment and system integration.
  • FMEA and Risk Management Process
  • Quality Systems gaps

 

We can also conduct a business ROI analysis to provide financial and process improvement justification.