The conventional approach to managing quality processes through a series of Word and Excel files stored on file servers is a logistical nightmare. When something changes, so many documents and data fields can be impacted and are often missed. Ensuring that each file is current and correct creates daunting amounts of busy work for engineers.

It is impossible to link any QMS object to any other QMS object (design controls to risk, CAPA to risk, documents to design controls, audit to nonconformance, etc.) in a legacy system; therefore, you cannot easily update and maintain information across the system nor ensure full transparency and traceability throughout the process.

Giving legacy systems a facelift does not change the fact the underlying architecture is outdated. Supporting old technology and architecture puts undue pressure on you and hinders your progress, especially if you are attempting to maintain an on-premise solution.

General-purpose systems do not provide medical device industry-specific templates, so you need to make significant modifications and updates to bring the system into compliance with any existing medical device regulations, and you need to stay current yourself on any new regulations that impact your system.

When you are forced to start from nothing and create and configure your workflows, you are facing extremely long implementation times and burdensome processes. A form-based system that is highly customizable is almost impossible to validate. A change to a workflow or to the structure of a form are events that require re-validation and any validation in this type of environment can take months.

Part 11 is merely a checkbox and not viewed as a functional architecture and process. It is typically an afterthought in general-purpose solutions.

Requiring a CAPA to be opened every time you need to conduct a root cause analysis, even for a complaint or nonconformance event, is incredibly inefficient and is not how a medical device CAPA system should work.