Table of Contents Ancillary or Raw Materials AM qualification Conclusion Regulations References These days, research and development of many pharma companies are focused on Cell and Gene Therapies, which bring hope for many...
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Dr. Anna-Lena Hürter
Future Lab – Digital Solution in Pharma Quality Control
This business case describes a project that KVALITO delivered for a Laboratory Information ‘Digital Solution’, which involved the implementation of a paperless GxP Process. Project Scope Implementation of a Laboratory Information...
Taking Shape: Artificial Intelligence Regulation and its Impact on CSV/CSA (III)
Part III: Overview Overview of CSV for AI-based systems Artificial Intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. AI-based systems are software systems with...
Taking Shape: Artificial Intelligence Regulation and its Impact on CSV/CSA (II)
Part II: Overview In the previous article, we discussed that AI has great potential to revolutionise the healthcare sector by deriving brand new insights from the data pool. Patients require protection from the elimination of bias built...
Taking Shape: Artificial Intelligence Regulation and its Impact on CSV/CSA (I)
Part I: Overview These days human life is touching Artificial Intelligence (AI) in one way or the other, for example, by searching for the next holiday destination over the internet, following Netflix recommendations on movies, asking...
GDPR- Changes in Data Privacy Protection Affects Multinational Businesses
This week, effective May 25th, 2018 the General Data Protection Regulation (GDPR) will be valid in the European Union (EU). This regulation harmonizes data privacy laws across Europe and replaces the current...
Data Integrity: Risks and Solutions
To ensure patient health and product quality, adhering strictly to Good Manufacturing Practice (GMP) is essential. One part of GMP, which is increasing in importance within the last few years due to higher FDA focus, is Data Integrity....
