In a previous article we looked at the emergence of MTP 4.0 (Industry 4.0 for the Medical Technology, Biotechnology and Pharmaceutical sector) as a holistic operating model to facilitate an agile development and manufacturing environment for the near future.
Being holistic, the operating model covers all aspects of the business, using a digital...
The Corrective and Preventative Action (CAPA) system is central to every Quality Management System (QMS). Quality professionals know the importance of managing CAPAs when a quality event occurs.
As a Pharmaceutical company, you are required to investigate the cause of quality failures or production problems. Surprisingly though, “Failure to thoroughly investigate…” is a common finding from regulatory inspections in the PIC/S, TGA and FDA GMP environment.
As a Medical Device company, you are required to investigate the cause of quality failures or production problems. Surprisingly though, “Failure to thoroughly investigate…” is a common finding from quality (management) system inspections and audits against FDA 21 CFR Part 820 and ISO 13485.
Your quality systems and procedures are in place, however no matter how much you try, people still don’t fully comply with them. These deviations and subsequent investigations lead to lost productivity. Typically you identify “human error” as the root cause and your corrective action is to train your team.
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