Compliance Group

Corrective A nd  Preventive Action ( CAPA )  is  often discussed   as it is an alarming issue for  the  life sciences industry.  Organizations consider its importance and try  to deal with it  better as CAPA ‘ s are the key indicators of a process that investigates the problems,  identifies  the source, solves the issue with corrective actions,  and prevent s  its  reoccurrences  by preventive  measure s.   Any flaws in the process would lead  to  FDA (Food and Drug Administration)    warning letters  and compliance grievance s .    So, iQuality has produced a step-by-step process to help companies handle the CAPA process to get satisfactory results in adherence to ISO (International Standards Organization) FDA regulations.    Every problem cannot be a CAPA and cannot ignore a minor NC (Non-Conformance), leading to a systematic issue. QMS (Quality Manage...

Errors are usually a part of any process, action, or activity. There is always a percentage of error that happens. The practice must be to refine it and bring the errors down as low as humanly possible.    To adhere with industry regulations and to remain compliant with various policies, quality processes of organizations have multiple checks and internal policies in place to address the non-compliances and errors that occur during the lifecycle of manufacturing a product. The focus of these processes is to address the errors, analyze them, fix them and ensure that they do not occur again.    Often during this process, the regulatory burden makes it difficult for quality process individuals to provide their complete focus to solving the errors in a way that they are traceable backward, permanently fixed, and provide insights about any matters that need to be addressed immediately.   One of the most talked-about and feared issues in a quality process is...