Blog

SeerPharma Blog listing page

Quality Management under MTP 4.0– Incidents, Suppliers/Material & Risk

May 24, 2021

In the previous 2 articles (linked below) we have looked at what the Quality Management System (QMS) of the near future (Quality 4.0) may look like under MTP 4.0 (Industry 4.0 for the Medical Technology, Biotechnology and Pharmaceutical sector).

Recall that, MTP 4.0 is a holistic operating model that incorporates digital technologies, data...

Read More

MTP 4.0 Quality Management Complaints, CAPA, Deviation, Docs, Training

May 20, 2021

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...

Read More

Quality Management under MTP 4.0 – Audits and Change Control

May 11, 2021

Industry 4.0, or the Fourth Industrial Revolution is a term used to describe the use of smart technology in manufacturing and industrial processes.

ISPE (the International Society for Pharmaceutical Engineering) has trademarked the term ‘ISPE Pharma 4.0’ to cover Industry 4.0 in the life sciences sector.

As the Industry 4.0 concept is equally...

Read More