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 Sarjen’s 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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In pharmacovigilance and in this industry largely, striking a regulatory balance undeniably precedes over anything else. If you are not regulatory compliant, you might be outmoded.
Product safety has geared up to what we call ‘optimal’ compliance.
These are few of the questions raised by Webinar audience regarding Literature automation module (LAM) of Sarjen’s PvNet and their appropriate responses
With the advent of technology, we are cocksure to upgrade ourselves not only to fear that we would turn obsolete soon but also to accomplish the objective of organizational Good pharmacovigilance practices.