Tackling 5 Key Challenges in Annex 11 and MHRA Readiness
Download the guide to explore how forward-thinking organisations are leveraging digital transformation in manufacturing to overcome regulatory challenges, enhance compliance, and gain operational efficiencies across multiple European sites and jurisdictions.
In today’s evolving European regulatory landscape, pharmaceutical, biotech, and medical device manufacturers face increasing scrutiny from EU GMP Annex 11 and UK MHRA guidelines. With 37% of GMP inspection deficiencies classified as “major” between 2013 and 2022, the need for robust digital manufacturing solutions has never been more critical. This white paper explores how forward-thinking organisations are leveraging digital transformation in manufacturing to overcome regulatory challenges, enhance compliance, and gain operational efficiencies across multiple European sites and jurisdictions.
Learn how to:
- Address five key challenges in European life sciences manufacturing through proven digital solutions.
- Reduce batch record errors by 90%-100% while accelerating batch release by up to 80%.
- Navigate complex multi-language, multi-site regulatory requirements with confidence.
Contact details: Download the Guide here.
Novo Nordisk
WLan Holding
AseBio