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The German Supply Chain Due Diligence Act and its Impact on the Pharma Supply Chain
Table of Contents The German Supply Chain Due Diligence Act (SCDDA) at a Glance Due Diligence Legal Framework for a...
Cell and Gene Therapy Products: Ancillary Materials and their Qualification
Table of Contents Ancillary or Raw Materials AM qualification Emerging Technologies Conclusion Regulations References...
Good Documentation Practices in Regulated Environments
"Proper documentation is the only witness of what you have done: in its absence, you did nothing; if it is poor, you...
Digitalization of Pathology – A New Approach
Development and Validation of Digital Pathology Digital pathology means the use of technology to accelerate and...
Risk-Based Computerized System Validation (CSV) and Computer Software Assurance (CSA) – Old Wine in a New Bottle?
“Discovering the unexpected is more important than confirming the known.” —George Box, Stuart Hunter, and William G....
LIMS Implementation: Success Factors from a Project Manager Perspective
"Change before you have to." —Jack Welch A Laboratory Information Management System (LIMS) is software that allows...
Sterilization Processes for Medical Devices
What kind of sterilization methods can be used for a medical device? There are different methods...
CDRH Validation vs. CSV
“A goal without a method is nonsense.” — W. Edwards Deming What is CDRH Validation? In the USA, the FDA’s Centre for...
How to Overcome Validation Costs
“It is thrifty to prepare today for the wants of tomorrow” — Aesop, Greek author (620 BC - 560 BC) Validation...
Medical Devices; US and Chinese legislation
US and Chinese legislation US legislation What is the framework of US Legislation? Figure 1: Framework of FDA...
Risk Management for Medical Devices: ISO 14971:2019
What types of risks are covered by Risk management? It covers the harms related to patients, users or/and environment....
