Compliance Group

Amid 2020, quality assurance leaders in the pharmaceutical, medical device, and other FDA-regulated industries highlighted compliance and production as part of their quality goals. Maintaining consistent compliance has remained part of the top three challenges the industry has been experiencing. How can firms in the life science industry overcome these challenges?   Software Quality Assurance   is the key industry trend and has many benefits in preventing mistakes to ensure compliance and patient safety. To summarize, software validation has been a requirement by the FDA since 1997. Software  Quality Assurance  (SQA )  is the set of activities that ensure processes, procedures as well as standards are suitable for the project and implemented correctly Furthermore, pharmaceutical and medical device companies may be one of the same. Today, many companies in the industry are still being audited and fined at high costs for similar but different compliant regulated i...

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...