FMEA and Computer System Validation

Case Study Life Sciences

A GMP product testing company utilizes our Regulatory and Compliance solution to identify gaps in their procedures and controls, resulting in the implementation of mitigation actions.  

SITUATION  

Our client was seeking to evaluate and assess existing systems, procedures and controls for potential gaps.  They also desired a partner that could begin implementation of any corrective actions identified during the evaluation. The partner needed to be able to evaluate, plan and manage Failure Mode and Effects Analysis (FMEA) related activities including:  

  • E-record and e-signature compliance 
  • Evaluation of laboratory systems to determine compliance gaps based on the FMEA 
  • Development of data processing maps for each lab system 
  • Computer system validation support 

SOLUTION  

Our engagement team was comprised of one validation lead and two validation engineers.  We developed and executed the FMEA, followed by the development of a Computerized System Gap Analysis checklist for laboratory system evaluations. Data processing map development and Computer System Validation work ran in parallel to the lab system evaluations. Our engagement manager provided oversight of the team, scope, deliverable production, budget, contract compliance and maintained consistent communication with the team and Client via weekly status reports and monthly Engagement Review meetings. 

"With the help of the well-managed and focused team, the FMEA and Gap Assessments quickly provided insight into our strengths and weaknesses, allowed us to pinpoint areas for improvement, and promptly begin implementation of mitigation actions."- Validation Manager 

RESULT 

We successfully delivered an FMEA with appropriately focused content, completed evaluations and development of data processing maps for 18 laboratory systems. We also provided Computer System Validation support for multiple software systems.  This enabled the client to quickly recognize and understand gaps, and begin implementation of mitigation actions, while still addressing the validation needs to incoming computerized systems.