Performing a Laboratory Informatics System Risk Assessment

Every software validation that is part of a Quality Risk Management program should start with a formal, documented risk assessment of the laboratory informatics (LIMS, ELN, SDMS, CDS, etc.) system being validated. Risk assessments consist of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. An assessment begins with a well-defined problem description or risk hazard, which allows for an appropriate risk management tool and the types of information that will address the risk question to be more readily identifiable. As an aid to clearly define the risk(s), three fundamental questions need to be asked for each potential risk:

  1. What might go wrong? (risk identification)
  2. What is the likelihood (complexity) it will go wrong?
  3. What are the consequences (criticality)?
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CSols, Inc. 
Informatics Insider