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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 did a poor job no matter what you really did." —Marco Polisena Introduction Good Documentation Practices (GDP) has evolved to be one of the essential...

Digitalization of Pathology – A New Approach

Development and Validation of Digital Pathology Digital pathology means the use of technology to accelerate and improve the workflow in pathology laboratories. It focused on data management based on information generated from digitized specimen slides by using virtual...

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. Hunter Introduction The World Health Organisation (WHO) specifies that “the purpose of validation is to confirm that the computerized system...

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 your laboratory to manage samples and associated data effectively. Its primary purpose is to improve lab efficiency and accuracy by reducing manual...