Molly has over 8 years of deep quality management knowledge from the pharmaceutical, medical device and laboratory fields. Molly is particularly experienced with FDA, HPRA, MDSAP and ISO 13845 audits.
Articles by Molly Calvey
ISO 15189
What is ISO 15189? A complete overview
Understand ISO 15189 and its impact on quality management in medical laboratories. Unpick ISO 15189’s requirements and embed lasting compliance.
Molly CalveyNov 10, 2025
Compliance
The ultimate guide to change control for life sciences companies
Change control is a key part of your QMS. Learn how to write your own change control procedure for a change control process that's compliant and comprehensive.
Molly CalveyMay 29, 2024
Medical Devices
14 medical device quality management system requirements for regulatory compliance
By understanding the medical device quality management system requirements for regulatory compliance, you'll be ready to help keep your company off...
Molly CalveyMar 20, 2024
Pharmaceutical
Understanding the major pharmaceutical regulations you need to know
Review the key pharmaceutical regulations you need to know and understand how they shape quality in the pharmaceutical industry.
Molly CalveyNov 7, 2023
ICH
What you need to know about ICH Q8
Review the fundamentals of ICH Q8 and its significance in drug development. Learn why ICH Q8 compliance is vital for quality-centric pharma companies.
Molly CalveyMay 17, 2023
ICH
ICH Q9 quality risk management: an introduction
Master the building blocks of ICH Q9 quality risk management with our breakdown guide, from risk assessment and control to communication and review.
Molly CalveyMay 15, 2023
GxP
Guide to GxP compliance: processes, challenges and tools
GxP compliance isn’t optional for life science companies. Review GxP requirements, critical compliance tools and the key facts of GxP compliance.
Molly CalveyApr 14, 2023
Pharmaceutical
What Are The Essential Elements of Pharmaceutical Quality Management Systems? [8 Examples]
Learn what makes the most effective Quality Management Systems (QMS) for pharmaceutical companies simplify complex cGMP and compliance requirements to drive TQM.
Molly CalveyJan 12, 2022