Ashok Nayak, CIO of the Indian multinational pharmaceutical company Ipca Laboratories, knows the pharma sector like the back of his hand. With two decades of rich experience as a technology and transformation leader, Nayak has closely experienced every single milestone that the industry passed through. He is also one of the few leaders who have had the first-hand experience on how the CIO role has changed and evolved over the years.
In this exclusive interview with CIO Dialgoues, Nayak talks in detail about how the pharma sector is poised for change, how the regulatory compliance environment is evolving and how CIOs are driving innovation.
You come with two decades of comprehensive experience in the Pharma and Life Sciences sectors. The role of the CIO has become more influential and challenging in the last one year. How do you see the CIO role evolving in your industry?
It's not only in the pharma sector, but across industries, the role of a CIO has changed drastically. As a Technology Leader, a CIO needs to have skill sets not only around Technology but Business and Soft Skills as well.
Since March 2020, when the lockdown was enforced, the focus shifted to work from home, and those who did not adopt technology suffered a lot. A CIO, who was playing the role of a technology enabler till then, was forced to get involved in the business as well. I feel this is the right time for all the CIOs to get into the role of a Transformation Leader.
In the current scenario, a CIO must shift gears and possess business acumen, with an ability to view “Big Picture”, weigh it quickly, and make logical decisions, and influence others. He must be flexible and forward-thinking, be strategical to create a unique approach for digital transformation, build teams and skillsets, take a platform-based approach and partner with technology providers than looking at implementing point solutions, and possess soft skills as a good communicator, collaborator, team developer, and influencer.
The pharma industry is a highly regulated one. Going by the exposure and experience I have in this sector, I see that legacy and compliance are the two key areas a CIO must focus upon to implement digitalization faster.
How would you summarize the massive changes that the pharma industry witnessed in the last year? What are some of the major trends you want to highlight? Where is the industry heading from here?
In this pandemic situation, the entire world is experiencing volatility, uncertainty, complexity, and ambiguity. It has changed the behavior from how do we work to where do we work? It’s difficult to imagine a situation in the absence of technology and how anyone would be able to transact the business.
In the current scenario, pharmaceutical companies are faced with challenges such as continuing manufacturing activities – which is dependent on the availability of a skilled workforce, managing supply chain and executing quality operations.
We don’t see much technology adoption in the highly regulated pharma sector. Technology disruption is much faster than our ability to change the process, culture, and behaviors.
Pharmaceutical companies need to embark on “Digitalization” to meet the market demands and to remain in the global competition. This is possible only by way of increasing efficiency and productivity. We are implementing technologies such as IoT, BOTS, and Intelligent Workflows in the areas of Manufacturing – IT/OT implementation;
Quality Management – Lab automation, QMS workflow automation and Supply Chain – Demand planning, supply, and inventory optimization.
Automation and adoption of various technologies definitely increase productivity and reduce the dependency of people. There will also be a major focus on IT security blending people, processes, and technology while agile infrastructure shall be key to meet the instant demands of the business.
You mentioned that digitization is picking momentum in the industry. Tell us about the digital/automation initiatives you have led at Ipca?
We have embarked on a number of digital initiatives and I would like to highlight these key ones:
Lab automation - Complete digitalization of material and products, testing activities integrating with instruments, and eliminating manual activities which led to a paperless operation. Lead to first time right, review by exception, increase in user experience, and a drastic reduction in product release time from 10 to 15 days to 5 to 6 days.
Quality Management – Digital workflows around quality management such as change control, deviations, CAPA, effectiveness check, market complaints, etc.
eDMS (Document Management Solution) – Managing unstructured information and availability of information is key in pharma companies.
Process optimization in core ERP – Work in progress, material movement on the shopfloor, material requirement planning and integration with expert systems, avoiding eliminating repeat processes and shorten process times.
Intelligent Workflows – Digitalization of decision-making workflows such as e-Log book, Schedule Manager, and Indent Management.
Business analytics is one of your key focus areas at Ipca. Tell us about your vision behind the business analytics project and how are you preparing the technology landscape at Ipca for the same?
‘Visibility’ and ‘Insights’’ of business are two key drivers for us. In today’s competitive business, the availability of information at every level of management is important to take instant decisions and observe performance or deviations. In the current pandemic situation, it is not possible to churn and message information every time. Hence we felt the need for connecting the dots between the data, and we built a data warehouse, which facilitates analytics at various levels, drills down information to the last level of records, provides real-time information on performance, KPIs, machine status, product status, compliance status, and deviations.
The machine and instrument data helps in predictive analysis and guides operators in real-time. Furthermore, it importantly helps in investigations with real-time data which is critical in the pharmaceutical sector.
Ipca is one of the rare players in the pharma industry to have its own homegrown application while most players leverage SAP. How is this giving you the advantage in effectively driving some of the key initiatives you mentioned above?
Yes, we have opted to have an in-house developed core ERP and other expert systems. All these solutions have evolved and matured over the period. Every option has its advantages and disadvantages. However, at this moment, the advantage balances out more to us than the disadvantages.
- Uniquely developed to our needs
- Easy integrations with other expert systems and solutions
- Easy customization to changing needs of the company’s regulatory and statutory requirements.
- Structured and clean data across the system.
- Automation and synchronization of process.
- High user experience
- Reduced dependencies on other third-party OEM / Partners
- Finally, optimized cost.
Compliance has been a strategic discussion point of pharma CIOs. What are your viewpoints on the pharma compliance landscape? How should tech leaders address some of the associated challenges?
The compliance expectation from regulators is extremely high. To execute the procedures as defined, we need well-trained people, availability of training records, multiple reviews and approvals of each action and or process steps, and data integrity.
All these compliances are driven by various guidelines from the regulators of different countries, which is not available as Rule Book. Therefore, the major fear is that the solution may not be accepted or needs to be highly configured which delays the entire process.
When it comes to regulatory expectations, emphasis must be given on data originality, availability, protection, and restriction with proper access. To ensure compliance, CIOs must stick to basics of compliance, ensure accuracy in the processes, evaluate rules, controls, and integrations to ensure data integrity. It is also important to draw expectations and intended use right in the beginning by taking functions in confidence. My experience has been to avoid overthinking or overdoing (try to minimise configuration). Instead, do a proper risk assessment and detailed validation (beside UAT).
Most importantly, whether it is manual or digitized operations, “Quality Culture” has to be addressed within the organization.