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.
Generic Industry Challenges:
Expiring patents, drying pipelines, increasing budgets, stringent regulations and cost pressures are some of the challenges faced by the Life Sciences industry. While these are macro challenges, teams responsible for clinical, regulatory and safety for clinical trials, regulatory submissions and patient safety respectively have a totally different set of challenges that they deal on a regular basis.
Data and documents generated during the course of the trials are managed by IT systems that have been either built in house or procured off the shelf. A major challenge that is faced by IT teams in large enterprises is to provide information and intelligence to their business teams that would cross (by integrating information) these siloes and help them make sound business decisions.
SOA based Information Integration:
Imagine a situation where all these systems in the clinical enterprise are integrated and connect seamlessly. The glue that binds all these systems can be a fully Service Oriented Enterprise Service Bus (ESB). Not just that, it should also be standards based. This will reduce the dependency on interfaces between systems in use and future proof the enterprise from replacement, retirement and enhancements to the individual systems. In order to bring visibility to data and documents across the systems there is a need to aggregate data and documents into Clinical Data Repository (CDR) and an Enterprise Electronic Document Management System (EEDMS).
The diagram above depicts a few information systems within the Clinical, Regulatory and Safety areas of Life Sciences R&D. This integration has to be:
- Loosely Coupled (SOA)
- Standards Based (CDISC / HL7)
- Open Architecture (XML, SOAP) and
- Survive system upgrades, replacements and retirements
Some of the advantages with the above mentioned integration would be:
- Integrated Clinical Enterprise Information Systems
- Easier and simpler integrations with partners and third parties
- Adoption of standards
- Integrated data and documents to enable faster decision making
- Faster Time to Market
- Lower Total Cost of Ownership and
- Better ROI