Say NO to Installation Guides for LS COTS Applications

We have come a long way in the last three decades, in terms of computer programs, from Punched Cards to Instruction Sets for Assembly Language Programming (ALP) to Command Line Installations to point-and-click installations. All these methods of programming a computer to automate business processes required step-by-step instructions to install and run the programs for end users to leverage.

I still remember the days when I punched a bunch of Red, Yellow and Green LEDs into a PCB and hooked it up to my 8086 programming kit to simulate the traffic lights. I am glad my program, before I fixed it, was not used for traffic light control systems because it would have been a global disaster :-). Jokes apart, my point is that the instructions that come with software are equally important and will lead to better customer satisfaction, leave alone save the IT teams loads of frustration.

The reason I brought this up is, it is one thing to understand the instructions provided in the installation manuals but it is totally a different beast when you are tackling the Installation Qualification (IQ) requirements with in the Life Sciences space. This process requires every step of the process being recorded, QA Reviewed and signed off. This is all part of the larger Validation & Verification process that is mandated for all IT systems used in the industry (for regulated processes) to ensure regulatory compliance and for a good reason.

While the installation guides provide detailed instructions for the installation of the commercial off the shelf applications, the IT teams will have to go through the process of IQ documents for the same software again. This is not only a tedious process but also requires lot of review cycles to ensure right amount of detail and coverage. I think there is lot of duplication in terms of effort that the COTS vendors as well as the IT teams in life sciences organizations spend to document these steps. My argument is that the vendors of Life Sciences COTS systems should instead provide IQ document in place of the installation guide.

I understand the fact that each customer could have different formats for IQ and also different ways of capturing the steps. However, if a tool vendor provides the IQ document, instead of an installation guide, at least the customers that would be able to adapt the IQ ‘as-is’ will benefit. This will lead to reduction in amount of effort spent, lower costs and faster implementation cycles.

So, I would like to make an appeal to all the Life Sciences COTS vendors out there….”Think About IT“.

Feedback and comments are welcome.


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About Venu Mallarapu

I am currently working as Director & Global Client Partner at Cognizant Technology Services in their Life Sciences division. I have over 19 years of experience in developing IT Solutions and Services, specifically for Life Sciences industry for over 13 years. I have worked with small to large pharma customers to address their business needs across R&D, Sales and Marketing and Manufacturing & Supply Chain areas. My passion is Pharma R&D. I blog and write about varied topics in Pharma Industry as well as latest Technology trends that impact Clinical Research and have also presented at various conferences and workshops on wide variety of related topics.

One response to “Say NO to Installation Guides for LS COTS Applications”

  1. Sandy Cascone says :

    Makes perfect sense to me.

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