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… Read More

Understanding Risk Management

Computerized systems have become a part of almost every aspect of laboratory activities and regulated companies are, therefore, making great efforts to raise their level of compliance with both the regulatory requirements and the expectations of governing agencies.  However, companies often end up creating quality systems and mechanical processes that are too rigid for efficient Computer… Read More