Pharmaceutical Warning Letters Reveal CGMP Failures
Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. [...]
15
09, 2022
1
09, 2022
Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]
25
08, 2022
EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of [...]
10
08, 2022
Overcoming Common Challenges of Customer Quality Complaint Handling
From food and beverage to electronics to CPG, there’s not a single type of manuf [...]
3
08, 2022
Supply Chain Traceability and The FDA Blueprint for Smarter Food Safety
From Listeria in ice cream to E. coli in lettuce, there’s one central question i [...]
26
07, 2022
How to Establish Sustainable Validation for FDA & EU Compliance
Software validation is historically one of the most difficult compliance activit [...]
20
07, 2022
FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
As innovation in medical technology increases, potential cybersecurity threats a [...]
13
07, 2022
QMS Configuration vs. Out-of-the-Box: Real-World Considerations
When evaluating an automated QMS, the question to invest in configuration vs. ou [...]
21
06, 2022
5 Ways an EQMS Resolves Change Management and Change Control Pains
In the life science industry, adjustments are a necessary element throughout the [...]
14
06, 2022
Why Calibration Management Software is Key to Proactive Quality
Unplanned downtime is an expensive issue, costing companies $50 billion every ye [...]
