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Branded softwares in Pharmacovigilance: Are we being unduly ‘overgenerous’ in name of Regulatory compliance!

2nd Jun, 2015

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Branded softwares in Pharmacovigilance: Are we being unduly ‘overgenerous’ in name of Regulatory compliance!This blog presents Industry expert’s views and expresses their opinions on the utility of ‘Branded software’ as a preferred solution under the misconception that only those softwares can ensure regulatory compliance.

Views of Quality assurance officer

QA Officer of a reputed CRO who faces various audits frequently said “as far as audit approach is concerned, there is huge difference when one is facing audit of Regulatory bodies like FDA, MHRA against that of Sponsors audits. Generally regulatory audits are conceptual and broad based on actual validation documentation, SOP and processes followed within the PvNET.

We ought to believe what we see or are made to see. Influence is a double-edged sword if lacks introspection!
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