Optimising IT resources in pharma industry with right governance tools

The main objective of any enterprise is the value creation for the stakeholders. Value creation means realising benefits at an optimal resources cost while optimising the risks. Stakeholders’ needs from pharmaceutical industry are very clear and unambiguous. The end customers, ie the patients, want safe and affordable drugs, without any harmful side effects. The regulators want a transparent system where the pharmaceutical companies follow good manufacturing practices (GMP). GMP involves immaculate record keeping with 100% traceability and absolute integrity of all systems, so that unauthorised alteration of records or procedures is not possible.
 
Shareholders expect the enterprise to run the operations efficiently, economically, profitably and also create new, path breaking, block buster drugs periodically through R&D.
 
The expectations from pharmaceuticals industry are really skyhigh but not impossible. Today’s information technology (IT) has become a major enabler to meet such demands. However, it needs creating an appropriate IT governance and management framework, ensuring a balanced approach towards deploying IT.
 
IT for better governance
There are a number of IT systems that should be deployed to achieve efficiency and effectiveness for running a pharmaceutical enterprise. For example:

• An Enterprise Resource Planning (ERP) system to manage production, inventory, electronic batch records, electronic packaging records, financial accounting, human resource management, training and development
• Laboratory Information Management System (LIMS) to handle information flow within the laboratory resulting in increased productivity, efficiency and quality analysis
• Sales Force Automation (SFA) providing web enabled solution to automate most of the routine activities of the sales, such as doctor visit report, tour plan, stockist inventory etc
• Customer Relationship Management (CRM) to automate and manage customer support

An IT governance oversight is essential to successfully build, implement, operate and monitor these systems and ensure that they meet the organisational expectations. This will require clear formulation of policies, procedures, frameworks, processes and organisational structure. It will also require clear understanding of the quality of information required for decision making, adequate infrastructure and well trained people. A very important but often neglected aspect of IT governance is the creation of right culture, ethics and behaviour. These are the enablers for IT governance as defined by ISACA’s COBIT 5 framework.
 
Banking on social media and mobility
IT governance enables organisations in the pharmaceutical industry to adopt and efficiently leverage SMAC (Social, Mobile, Analytics and Cloud) technologies. Innovative mobile-based applications can really change the medical care approach. For example, intelligent medical devices (eg, heart monitors, glucose meters) unobtrusively collecting information on patients’ health and sending to tablets or smart phones of medical practitioners, using the wireless technologies. An electronic ‘patients tracking and monitoring system’ helps patients suffering from diseases like Alzheimer’s disease, quickly locating them and providing emergency assistance.
 
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Using social media for sharing information about medical conditions, complaints and medical advice. These are valuable information sources for the pharmaceutical enterprises to improve their offerings and also their image.
 
Technologies can help in developing personalised medicines based on genetic profiling for more targeted treatments. Using cloud computing for simulation models can make them very cost effective compared to in-house implementation. Doctors can access reports through applications like WhatsApp and provide prompt medical advice much before they actually visit the patients.
 
These and many such applications can be developed if the organisation has identified ‘Manage innovation’ as a critical IT process and provided direction and resources.
 
Guard against IT theft
With various internal and cyber threats looming over the pharmaceutical industry, IT governance can effectively addressing these challenges. Intellectual property protection is most critical for pharmaceutical industry. After all, billions of dollars are invested in new discoveries. Insider threat is probably the most potent threat, accentuated by easy access to information through wireless and mobile networks.

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IT governance framework ensures selection of right processes like ‘Manage risk’, ‘Manage security’, ‘Manage security services’ and also helps in selecting the right monitoring tools. A RACI chart (Responsible, Accountable, Consulted, Informed) makes sure that the persons dealing with IT, including the IT security aspects; are very clear about their roles and incidents do not go unattended.
 
Pharmaceutical companies can adopt the best practices offered by an IT governance framework such as COBIT, which can help them choose the right technologies and platforms. COBIT 5 is a ‘Business Framework for Governance and Management of Information Technology’. It integrates governance of enterprise IT into enterprise governance.
 
A pharmaceutical enterprise that has adapted COBIT 5 framework for IT Governance is in a better position to face the challenges in this highly competitive world.
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The author is the Advisor to ISACA India Task Force, and is one of the leading experts on information security wih more than four decades of experience in IT management, information systems audit, and information security consulting and training.