Life Sciences Archives

How to Comply with ICH Q9(R1) 2023 (Pharmaceutical Quality Risk Management)

By John Lafferty, Life Sciences Programme Director at SQT Training Ltd. Read time: 5 minutes The 2023 revision of ICH Q9 (R1) Quality Risk Management guideline brought several clarifications and enhancements to the way the pharmaceutical industry should approach risk management....

Hosting a Regulatory Audit? Three Essentials Every Medical Device Company Should Know (MDSAP & ISO 13485)

by John Lafferty, Life Sciences Programme Director at SQT Training Ltd. Read time: 4 minutes. Why This Matters for EU & Irish Medical Device Companies For medical device manufacturers across Ireland and Europe, regulatory audits—whether under MDSAP or ISO 13485—are a cr...

EU MDR 2017/745: What Importers & Distributors Need to Know (but Often Don’t)

Understanding your responsibilities under MDR and why so many organisations are only discovering them now. Author: Anne Marie Newell Over the last few years, the EU Medical Device Regulation (EU MDR 2017/745) has reshaped the responsibilities of companies handling medical device...

FDA’s Draft Guidance – A New Dawn for Software Validation

By John Lafferty Article updated: March 2025 Read time: 3 minutes The draft guidance entitled Computer Software Assurance for Production and Quality System Software (dated 13th September 2022) represents a new dawn for software validation in a manufacturing environment. New: Un-...

How to Make Software Validation Easier for Compliance with ISO 13485 and Pharma Regulations

By John Lafferty Read time 12 minutes Software Validation just got a whole lot easier. The effort required comply with the software validation requirements of ISO 13485:2016 and 21 CFR Part 820 has been greatly reduced due to recent changes in regulations and guidance. Under th...

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