AI in Medical Device Manufacturing: How It’s Transforming an Industry
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first A [...]
FDA Inspection Expectations in 2025
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspect [...]
Critical Aspects of Quality Management Systems: Focusing on the Validation Process
In regulated industries like pharmaceuticals, medical devices, and food manufac [...]
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]
5 Places to Use a FMEA in Your Quality Process
Before any road trip, it makes sense to check your tire pressure along with lev [...]
The Role of Technology in Supporting ALCOA Principles: Strengthening Data Integrity in Life Sciences with Quality Management Software
In the highly regulated world of life sciences, data integrity is not optional [...]
Ways to Influence Stakeholder Buy-In During the CAPA Process
How can a quality manager secure stakeholder engagement and hold individuals ac [...]
CAPA is a Process, Not a Project: 3 Key Strategies for Success
The challenge of the quality manager is to convince stakeholders of their respo [...]
Overcoming Deviations and Non-Conformances in Manufacturing: The Power of Automating Quality and Compliance
Manufacturers widely view process improvement frameworks like Lean as the solut [...]
How to Use the QMS to Support Lean Manufacturing Initiatives?
Manufacturers widely view process improvement frameworks like Lean as the solut [...]
