SMART quality & compliance
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 Good Practices in regulated environments such as pharmaceuticals manufacturing for many years now. Having developed from predicate rules for record-keeping in quality system management, as well as 21CFR 11 for electronic records and electronic signatures, GDP has evolved to become a quintessential tool for documents industry. “In any regulated industry, documentation can provide…
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SMART quality & compliance
Bite-sized Knowledge: Medical Device Regulation
2A Regulation shall be applied in its integrality in all the European Union. Unless a Directive is 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 Direction and Regulation. Adapted from European Law. Copyright 2020, Kvalito Consulting Group. Citizens and Companies implement their policy (act) according to their National law which is an interpretation of the European law. Citizens and companies implement their policy (act) according to European law. What are the changes in Medical Devices regulation? The European Parliament has…
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