Viewpoints By Teresa Jacob

Article: PLM-Enabled Quality Compliance for Medical Device Part 7 – Production & Process Controls

This blog demonstrates how the collaborative environment between PLM, ERP and MES helps ensure that a product conform to its specifications.

Article: PLM-Enabled Quality Compliance for Medical Device Part 6 – Equipment & Facility Controls

Leading practices for managing equipment and facilities controls within ERP and MES - inside the scope of PLM.

Article: PLM-Enabled Quality Compliance for Medical Device Part 5 – Material Controls

Medical device manufacturers must maintain a uniform system that tracks materials and suppliers for quality purposes. Here's how PLM - ERP - MES collaboration supports this need.

Article: PLM-Enabled Quality Compliance for Medical Device Part 4 – CAPA

Here’s how life science and medical device companies can implement standard support for CAPA management through the guidance of PLM.

Article: PLM-Enabled Quality Compliance for Medical Device Part 3 – Records, Documents and Change Controls

For medical device and life sciences companies to be compliant, they must maintain a secure central data and records management system. Here's how to leverage PLM to manage records, documents and change controls.

Article: PLM-Enabled Quality Compliance for Medical Device Part 2 – Design Controls

PLM enables FDA compliance in many areas, including design controls. Here's how medical device companies can leverage PLM to enable visibility across all projects and product design activities.

Article: PLM-Enabled Quality Compliance for Medical Device Part 1 – PLM at the Core

This blog series will focus on the systems that enable life science and medical device compliance, starting with the core system - product lifecycle management (PLM).