Written by: Crystal Booth, M.M.- Regional Manager, Southeast USA at PSC Biotech

Are you finding yourself with repeated deviations or complex processes that slow you down? Did you go into an audit feeling ready and came out the other side blindsided by a 483?

Making multiple changes in processes over time, whether to prevent deviations or adapt to changing regulations, may create hidden obstacles, unnecessary or redundant steps, and broken links in procedures.  You may end up with standard operating procedures that no longer talk to one another properly, thus creating more deviations when an employee gets confused.

Identifying your desired state of operations and seeing your future state operations can be overwhelming.  How do you get to your future state without stopping and starting all over?  A gap assessment can help identify broken links and streamline processes to accelerate your success.

A gap assessment will compare your current state of operations to your desired state of operations.  In doing so, the analysis will identify gaps and areas of improvement.  In general, the steps of a gap assessment include:

  1. Identifying and documenting your future goals or desired future state of operations.
  2. Identifying and documenting your current state of operations.
  3. Comparing the current state of operations verses the future state of operations.
  4. Using gap analysis tools, such as Ishikawa, to find potential gaps and identify potential solutions.
  5. Evaluating the potential solutions by developing a plan to test one of the solutions.
  6. Testing one of the potential solutions with a small-scale study to see if processes improve.
  7. Analyzing the results of the study.
  8. Creating a plan to bridge the gap and implement the successful change into the routine process.

PSC Biotech™ provides custom fit options to help companies perform gap assessments of their operations.  Because regulations and guidance documents are periodically updated to help the industry adapt to current Good Manufacturing Practices, adjusting to the changes can be difficult for small and large companies alike.  Experienced consultants are available to perform gap analysis to ensure your current processes are compliant.

PSC Biotech™ has a wide variety of solutions to ensure success for any size company.  Some of our offerings include consulting, performing risk assessments, writing standard operating procedures, writing protocols, writing white papers, project management or even executing projects to free up your company’s valuable resources.  Whatever your need may be in the life science industry, PSC Biotech™ will be there to help. Give us a call today!

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