Compliance Group

Part of that process is ensuring a document management system is in place, beyond just doc control. Ideally, it’s an electronic document management system since we’re well into the 21st Century now. Surprisingly, many companies are still on paper instead of the cloud.   So what’s involved to get an eDMS in place?   Many med device companies do have some kind of document management system in place to produce a required design history file per the FDA’s 13485 guidelines. These companies also need to capture various forms of data from the contract manufacturing organization or CMO, including design verification along with validation testing of their eDMS.  Additionally, design controls, equipment specifications, materials, and technician training need to be completed. All of this documentation is an integral part of product lifecycle management.  Before any medical device can be released onto the market, the burden is on device producers to demonstrate that their...

 The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance within the organization. A non-conformance occurs when a product or service, or process deviates from the industry specifications. Therefore, it is not surprising that product delivery is crucial when satisfying customer expectations, market trends, management profits, and compliance.   With regular Non-Conformances (NC) , the organization’s efficiency, product-process effectiveness, brand reputation, and company finances are questionable as customers’ health and safety can be adversely affected. So, when a non-conformance occurs, rather than seeing it as an issue, see it as an opportunity to fuel the continuous improvement of the product/processes using the findings. The key to opportunity lies in how well the investigation findings are documented and how well the non-conforman...

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...