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 Sarjen’s PvNET.

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

While, most of the auditors coming from sponsors are normally highly influenced by suave marketing representatives of large brand software companies. Their thinking methods and perceptions are created with targeted commercial data poured over using various mediums.”

Perspective of those who think ‘it’s safe in going with the flow’

CIO of a large pharmaceuticals manufacturer in generic drug was of very strong opinion of going with big brands to avoid unnecessary audit queries. “I need to be thorough with my study on system documentation and necessary information on each software system implemented under GxP if supplier happens to be a local or a small time vendor. I seriously do not have time or intension to get into that area or take that additional accountability on my shoulder even if that saves some money for my organization. Ultimately, we are technology people and just facilitators.

User will pass even smallest audit query related to system in the pre-text of very difficult IT problem to address. It may be a perceived threat, but I would like to remain in my comfort zone”. The same perceptions is echoed by several pseudo-IT professionals responsible for vendor selection.

The height is that some of them have even gone to the extent of replacing all computer systems of organizations to branded computer machines by the likes of HP, as he thought only HP machines would be acceptable to US FDA.

Perspective of those, who have the courage to do things differently!

Head of Regulatory Department of a huge pharmaceutical company expanding very rapidly; echoes the view of generation next. “I know my subject and my needs better. If Auditor’s has a query on my process of my work, I am able to answer. I would prefer the software vendor who is innovative, adaptive and eager to serve my needs. Software solution is of no use if it is non-adaptive to processes under the pre-text of being robust.

ROI is an extremely important parameter and can no longer be ignored. It is important for software solution provider to follow the software development guideline of various agencies, and it is important for software validation team to validate the software properly. That’s all auditors and agencies need. That’s what they look for!
Unlike my predecessors and veterans in the industry, my decision would more be driven by real value against perceived threat.

Undoubtedly, the Industry is indeed divided with the balance shifting towards exploring newer software brands to achieve their realistic goals!

To be continued…
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