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Computerised System Validation vs Computer Software Assurance by the Example of ERP System Validation

The pharmaceutical, biotech, and medical device industries are subject to strict health authority regulations to protect data integrity, product quality, and patient safety. Validation of computerised systems is crucial for nailing these three objectives. Life...

What’s the difference between a Regulation and a Directive? 

A regulation shall be applied in its integrality in all the European Union. Unless a directive sets out an objective provided by the European Union, each country is free to develop its own measures to achieve this objective. Figure 1:Overview of the difference between...

How to Increase Quality Through Risk-Based Business Process Mapping

/graduateIntroduction  Nowadays, more and more companies start to grow and lose visibility of the organization’s global landscape. This causes some issues, such as a lack of communication between the sites, work duplication, and a loss of control of the company’s...

FDA Forced to Evolve its Toolset Amidst Mounting Inspection Backlog in the COVID-19 Pandemic

When FDA applies more advanced technologies to its work, stakeholders can explore new ways of developing FDA-regulated products and new methods of generating data to inform the regulation of those products[i]. — FDA In a letter[ii] to Janet Woodcock, acting...

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