Medical Device Manufacturers, Rejoice
If you’re in the medical device manufacturing (MDM) industry, you’re familiar with the reality that healthcare regulations, while necessary and good, can choke your business’s productivity in a noticeable way. However, the quality of your productivity is entirely dependent on meeting these FDA standards. How can your business better thrive within these boundaries?
By streamlining the process of creating CAPAs (Corrective and Preventative Actions) in your manufacturing process, you can produce more reliable accounts for auditing purposes and minimize potential recurrent issues. This means less labor put towards the meticulous task of tracking and advancing the CAPA through its various stages.
CAPA Creation in the Cloud
Both Corrective Actions and Preventative Actions can be created for analysis as “types” under the document designation of Corrective Action Report (CAR). CARs can be sourced from and tagged to specific Non-Conformance Reports (NCR) in the Material Review Board (MRB) and Management states of the NCR workflow, visible to all users in real time. The evolution of your CAR occurs in four states: Creation (State 1), Review (State 2), Validation (State 3), and Conclusion (State 4). Cetec ERP supports an automated workflow for how CARs are routed along these four states throughout the company. This procedure saves valuable time searching for documents and communicating information between employees by doing all of it for you.
As the CAR travels, users can input data on root cause analysis, corrective and preventative actions and to whom enforcement of these is assigned, as well as issue resolution. The CAR is then ready for review and closure. CARs can always be re-opened for further review by reopening its designated NCR.
Throughout the entire process, the CAR is available to view, download into a zip file or a PDF, print out on paper, or delete. Users can also utilize the CAR list, in which one can search and filter across all open and closed CARs in your system.
Within Cetec ERP’s open source PHP software, our quality management system allows medical device manufacturers to easily screen their workflow for possible defects and quickly resolve non-conformance issues. The pains of fulfilling CAPA procedures can be mitigated, and spending less time and labor on this protocol frees your business up for greater efficiency and productivity.
Check out our tutorial on how to smoothly create a CAR within Cetec ERP software, as well as an overview of our integrated QMS:
Corrective / Preventative Actions (CAR, PAR, CAPA) Documentation