The GAMP 5 computer system validation guidance on the risk-based approach to GxP computerized systems laid out a framework for validating laboratory informatics systems (among other systems). This framework has been the gold standard for risk-based assessments since its publication in 2008. The International Society for Pharmaceutical Engineering (ISPE) published an updated Good Practice Guide:… Read More

Imagine…historic rainfalls flood your production facility and its lab, while knocking out power for miles around. Your analytical equipment is ruined. Your server is under water. Or, wildfires ignite suddenly after a lightning strike or car accident. The fires spread rapidly. Lab personnel have just enough time to escape with what they can carry. Your… Read More

OK, so you know that Risk Management is an integral part of computer systems validation and you’ve already completed the System Risk Assessment and produced a full set of lifecycle and validation documentation. Is the system ready to be used? Are we there yet? The idea of “one-and-done” risk analysis puts your company at risk… Read More

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

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