We cannot provide guidance based on technical concepts, approaches, or techniques that are in some cases decades old, even if they do sometimes remain enshrined in regulatory guidance or company policies and procedures. We must always ensure that GAMPĀ® guidance is well-aligned with current good practice. One of the reasons GAMPĀ® guidance has always been successful, is that it has reflected the current good IT and software engineering practice, based on input from experienced IT, automation and software practitioners. As a society and as an industry we have learned some important lessons from the global COVID-19 pandemic, not least that innovation and technological advance are essential to safeguarding patient safety and public health, and that industry and regulatory flexibility is vital in meeting these key objectives.
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