Paperless or Not? Manmeet Singh Weighs In on Pharma's Digital Evolution

Manmeet Singh, currently serving as CIO and Vice President of Information Technology at Lambda Therapeutic Research, is a seasoned IT leader with over 23 years of experience in the Healthcare and Life Sciences industry. He specializes in software portfolio management, quality systems, software validation, infrastructure qualification, and IT risk management, with expertise in GxP compliance and US FDA 21 CFR Part 11 standards. An MBA graduate from IIM Calcutta, Manmeet has led the implementation of transformative solutions such as Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), and CRM systems, streamlining operations in pharmaceutical manufacturing and telecom sectors. Known for his strategic vision, hands-on management, and team leadership, he consistently delivers large-scale projects on time and within budget, driving quality and operational excellence.

Pharma Now: Welcome Mr. Manmeet Singh, to Pharma Now. Currently, you're the Chief Information Officer (CIO) at Lambda, one of Asia's largest contract research organisations (CROs). Thank you for joining us at Pharma Now. As you might know, a lot of our readers are young professionals and budding leaders. So, learning about your journey to becoming a CIO of such a large company, your strategies in the digital transformation area, and your thoughts about trends in digital transformation will inspire them. You started your career in the telecom industry, but now, you are the CIO of one of the largest CROs in Asia. How did you switch fields and become the CIO?

Mr. Singh: I started my journey in the early 2000s. I am a science graduate and completed my MBA in Information Technology from the Somaiya Institute of Management Research, Mumbai. After MBA, I started my career in the telecom industry. In those days, telecom was a booming industry that was undergoing digitalisation. Telecom companies were making several predictions. “The telecom era will evolve. People will start chatting and receiving video conferencing calls on phones. People will surf the internet, trade, and do banking on their phones.” But, in the early 2000s, this was just a dream because, back then, people had landline phones. Now, when we think about it, it was a blessing in disguise to have a landline phone at your residence. 

Slowly, we moved to T9 phones, which have 0-9 keypads. You must have used this phone–it was mainly for calling and sending and receiving messages. The display screen was small. People couldn’t imagine how they could attend a video call, do online banking, and surf the internet on it. In those phones, whenever you tried to open Google, it took at least 1-2 minutes, which was not feasible. 

Then, the industry realised it was not only about upgrading handsets–technology also had to evolve. First, we moved on to GPRS, then to 2G, 3G, and 4G. Then, touch screen phones were invented, which changed the way we communicated with each other. Now, we do not need to ask for an address; we can directly type it on Google and reach the destination. Today, calling multiple people in a video conference call is just a click away.

Pharma Now: Yes, that’s true. There have been a lot of huge technological developments that have brought us here. After working in telecom, you switched to pharma. To my understanding, they’re very different fields. How did you start your career in the pharmaceutical space?

Mr. Singh: I started my journey in telecom and eventually moved to the pharmaceutical domain. The life science space comprises three industries: clinical research, pharmaceuticals, and health care. So, I started my journey in the pharmaceutical industry in 2007 with Reliance Life Sciences. Reliance Life Sciences is a small company in biopharmaceutical manufacturing. However, its nature of business is more complex than that of any big pharmaceutical compay. This is because Reliance Life Sciences is a CRO. It conducts animal studies, all four phases of clinical studies, plasma manufacturing, biopharmaceutical manufacturing, generic pharmaceutical manufacturing, and stem cell research. It’s a small company with a valuation of around 1000 crore, but its business has been very complex since 2007. 

So, I started my pharmaceutical journey with Reliance Life Sciences. My major initiative was to digitise each domain. So, we began with the clinical research domain and implemented some digitalisation plans. Then, we move on to manufacturing and laboratories areas and finally to research and development (R&D). 

Pharma Now: Oh, I didn’t know how digitisation projects were undertaken in large pharma companies, but it makes sense to digitise domains one-by-one. So, what was your role in Reliance Life Sciences? Who helped you with your digitisation projects?

Mr. Singh: I joined as a Senior Manager. In the 13 years I worked there, I grew a lot. Then, I shifted to Sun Pharmaceuticals as an Associate Vice President. So, I worked on digitalisation projects with my peers. Digitisation is not a one-person job because there are multiple areas, and I cannot reach every area. So, people in different teams started implementing small digitalisation plans in their areas, and we pieced everything together to seamlessly integrate users.

Pharma Now: That’s understandable considering how comprehensive the requirements for digital transformation are. Currently, digital transformation and digitalisation are buzzwords, and many people don’t understand what they mean. So, can you shed some light on what digitalisation is and how it’s achieved? 

Mr. Singh: Digitalisation is very simple: It mimics your paper process electronically. In short, it is just an electronic replica of a paper, we say paper on glass. We cannot go paperless everywhere. So, it’s just a buzzword. But the right way to think about it is: “It is not paperless; it is less paper.” Paper will always be there. Manual decision requirements will always be there. 

Digitalisation is how you connect everything so that you have more decision-making power. For example, when you make decisions now, you rely on systems to provide insights that will help you move toward a decision quickly. This is the era of digitalisation. 

Pharma Now: Thank you for explaining digitisation in a manner everyone will understand. Today, experts say that digitisation of the pharmaceutical industry is difficult, challenging. What’s your take on this?

Mr, Singh: Digitisation in pharmaceutical manufacturing will take time. The challenge for digitisation in pharmaceutical and CRO industries is regulation. We directly affect patients’ lives. Hence, we are more susceptible to audits. In the CRO and pharmaceutical industries, regulators continuously monitor companies, not just Indian regulators but also international. The reason is simple: Indian pharmaceutical companies do not want to be limited to India. They also want to operate and market products in European and Latin American markets. So, they are susceptible to audits from authorities in these countries.

For example, if you wish to market your product in the US, your product has to be approved by the US Food and Drug Administration (FDA). Similarly, in Europe, the European Medicines Agency (EMA) has to approve your product and in Latin American and Brazil markets, the National Health Surveillance Agency or Agência Nacional de Vigilância Sanitária (ANVISA) has to prove your product. In the Indian market, the Drug Controller General of India (DGCI) does the approval. So, companies are being continuously monitored by regulators, and they don’t know when audits will happen. 

Some Indian companies produce only active pharmaceutical ingredients (APIs), which are the core ingredients of any tablets and injectables. So, the drug manufacturing company can produce APIs in-house or outsource APIs to any other API manufacturer. While filing for licensing with a regulator, you have to mention everything–your API's source, where it was tested, and how the drug formulation was made. The regulator may also audit the API manufacturing company; this is how the audits get triggered. So, because of so many steps, regulations, and audits, digitisation is complex and delicate

Pharma Now: Yes, getting the product into market is certainly a huge challenge for all companies. But, don’t you think digitalisation will make these audits faster?

Mr. Singh: My straightforward answer is yes, digitalisation will make audits faster. 15 years ago, when everything was on paper, auditors came from the US and Europe. Before arriving, they sent multiple formats, asking you to fill out all documents in specific formats and get back to them. But, companies completed batch manufacturing and testing on paper. So, to submit these documents to auditors, they had to fill these specific required formats in Excel and then input the data. All of this was time-consuming. If you look closely, this was a specific reactive approach where things happened on paper and then transcribed them Excel. Afterward, auditors would review the data, visit the plant, perform an audit, and give us observations. In the end, some audits were cleared or sent for observation.

Now, business leaders in pharmaceutical manufacturing and quality control (QC), which is the heart of the entire process, have understood the need for digitalisation. They’ve understood that we cannot do duplicate work–first write on paper and then in Excel. They’ve realised we can do it once on Excel, extract the data, and submit it to regulators. So, the end users said, “We need to change things.” That’s how the digitalisation journey slowly started in pharmaceutical and clinical organisations, and regulations and the environment drove this journey. 

Pharma Now: In other industries, digitalisation was very rapid. But, in the pharma industry, digitisation has been slow due to several challenges. Can you tell us what the major challenges are, particularly in pharma manufacturing or clinical research?

Mr. Singh: The first major challenge is documentation. For example, if I convert any manual process into an electronic one, I need to produce documentation proving that this particular automation gives me an output equal to what I get via the manual process. This has to be documented very thoroughly. User requirement specifications are used to create a procedure. They are translated into design specifications, which are then validated. Typically, we call them installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) in the pharmaceutical industry.

Auditors who come to our facilities for audits don’t just see our faces and say, “Hey guys, you are doing a good thing. There’s no need for documents.” No, the auditor will see all documents. This documentation actually takes time. But if you adopted standard software from a large original equipment manufacturer (OEM), the documentation is simple. You only have to input the exact date and time of the process, and you get all the data. 

The second challenge in the pharmaceutical industry is data relevance. Old data is not allowed. So, if you’re completing a process, you need to capture the data on the spot. You cannot use old data, even if the end results are the exact same. This is why we are lagging. In the retail industry, documentation is not this comprehensive, except in testing. Once you are satisfied with the testing results, you move onto production. 

Finally, another major challenge is margin. In the retail industry, if something happens in production, you have a way out. For example, I am giving a 48% discount on a product, but my system is not working correctly and shows only 50%, it is not going to impact the end customer. I can say, “Okay, there is a mistake in the system, but you can take an additional 2% discount.” But, in pharmaceuticals, this margin is not there. The patient consumes the medicine, and the decision made by the software will impact their life. That is why documentation is essential. This is why digitisation is slow, the system will eventually impact a person’s life.

Pharma Now: You’ve put it quite eloquently. So, during your 13 years in Reliance Life Sciences, which initiatives did you take for digitalisation? Can you share a little about your setbacks and breakthroughs?

Mr. Singh: So, during my tenure at Reliance Life Sciences, the clinical trials management division implemented CTMS solutions for clinical research. Lab information management systems were implemented across all three business verticals of Reliance Life Sciences–pharmaceutical, biopharmaceutical, and plasma manufacturing. The lab information management system was implemented across all three verticals and electronic lab notebooks were implemented for laboratories. Reliance Life Sciences had eight research manufacturing units that performed stem cell and plasma manufacturing research, and electronic lab notebooks were implemented across all these R&D units. We also undertook sales force automation for field executives and quality management systems.

Pharma Now: Implementing electronic lab notebooks across so many verticals and laboratories would have been very challenging. Can you tell us what electronic lab notebooks are, and how they automate processes?

Mr. Singh: Simply put, scientists do experiments, and their primary task is to develop a new molecule or product. During this process, they manually write a lot of things in a green book called lab notebooks. In these green books, they transcribe everything manually and attach results from instruments. They also draw chemical structures and other details. In the end, they send these books for review and approval, and the book is stored.

Once the experiment is successful, we do tech transfer to manufacturing. For example, once the experiment is successful at a small R&D scale, it is manufactured on a large scale. Before digitisation, this tech transfer from R&D to manufacturing happened on paper. So, once electronic lab notebooks were implemented, experimental data was recorded electronically. 

In the first try, they are not beneficial. But, over time, if you’re doing the same experiment, the system will provide tips like, “If you are going to do this, you will face a challenge during step 5”. Hence, the notebooks help scientists. They also design molecular formulas, which were previously done manually. 

Pharma Now: That is fascinating, and I’m sure it cuts down a lot on research time. This is especially fascinating for me because I, too, have worked in a technological transformation company. So, when we implement any new digital initiative in a client organisation, the first step is adaptation. But, there is always a problem in adapting to the latest technology: users resist. That is human nature. So, I want to understand, as a digital transformation initiator, how did you tackle this challenge and convince your users to adopt and benefit from technological upgrades?

Mr. Singh: That’s an excellent question. We will face less challenges in technological adoption if we communicate the exact benefit to end users. Users believe that there will be job loss if technology is used. You have to change their mindset. Firstly, you have to convince them that there will be no job loss. Then, you communicate the exact benefits of the new process. 

Some people say the top-down approach is a better approach–one where you implement change from the top of the chain to the bottom. The top-down approach will only work once. It is better to openly and transparently handle transformation. Listing down everything you will digitise in Phase 1. People may ask for something you cannot provide. So, very openly discuss the aspect, and tell them, “In the beginning, I can only give you three things out of the 10 you desire.” But give them the three pieces that will contribute to 70% of their problem areas. This will help them understand the benefits of the new transformation. 

You should show them what they will gain. Don't try to fit all transformation phases in one go–it will fail because you must also have to run operations. You cannot directly shift your operations from paper to electronic in one day. It is a step-wise process. 

For example, when transitioning from paper to electronic notebooks, you have to continue on paper for some time. Then, for some new batches, you use electronic notebooks. This will give you some confidence. Then, you start adapting to electronic notebooks and avoiding paper. After 6 months, you may use electronic notebooks for 90% of tasks and paper for the remaining 10%. This will build confidence. You can’t ask employees to switch from one process to the next within one day. That’s difficult, it’s not digestible, it’s challenging, and it will not work.

Another challenge is minimising the interface between the old tech and new tech. For example, in pharma, products may be manufactured and tested in batches. So, in QC, if there are any issues, several investigations are undertaken, which takes a lot of time. So, in such situations, how do you track the progress–do you use the old tech or new tech? In either case, you have to use one. Minimise the interference between the two techs, and use only one, whichever is essential. For example, if you use both enterprise resource planning (ERP) software and quality management systems (QMS), don’t make decisions on both. During QC, if you decide the batch shouldn’t go to the market. Update the decision on QMS and put the batch on hold in ERP. Then, once you clear the decision in QMS, unhold the batch in ERP so the batch can go into the market. This makes sure there’s minimal interference.

Pharma Now: Correct, you must take one step at a time to make sure you don’t fail at once. Being in this field for a couple of decades, you must have failed in some projects or not achieved the desired results. How can you plan your digitisation to avoid running into too many issues?

Mr. Singh: First, you need to decide what you want to digitalise? You should write the problem or statement very clearly. Second, sit with your technology partner and decide whether you want to develop the technology or you want to purchase off-the-shelf software. If the answer is purchasing off-the-shelf software, consider commercially available off-the-shelf software perfect for your process. In such cases, the objective is to migrate the manual process onto the particular commercial shelf software. 

If the company wants to build a software instead of purchasing one, they have to choose analysts. The analyst will speak with production executives and other people, identify the requirement and then develop and test the software. 

These two processes are implemented across multiple companies. Most pharmaceutical companies do the same thing. There are some instances where you can deviate, for example, instead of three-level approval, you can implement four-level approvals. But the majority of the process, which has been set in the COT solution, you have to adopt that. If you change your COTs as per your manual process, you’ll fail because there are a lot of hidden things that are not a part of documentation in the URS. These things you miss, resulting in challenges. Then, the software is not launched, so you need to revise it. 

Pharma Now: Correct, there are a lot of things that you may not know right from the beginning. I think that’s why people need to keep an open mind when adopting new processes and technologies.

Mr. Singh: Yes, you need to keep an open mind. Only then you exactly see what the software should do. Then, you can relate and change your SOP. Then, you can train people. This makes it easy to adopt to new changes, and you benefit from the new adoption.

Pharma Now: Yes, correct. So, in the past few years, especially since COVID, technology has rapidly evolved. There are many new technologies, for example, AI, deep tech, and blockchain. How do you think they will impact digital transformation in the pharma industry?

Mr. Singh: AI is being adapted by the pharmaceutical industry, but not fully. Some particular use cases are being adapted. In the pharmaceutical industry, there are two important terms: GMP and non-GMP. Non-GMP is not linked with customers. It has more to do with HR and finance. In these non-GMP areas, like HR and finance, the complete digitalisation is happening, for example, we are implementing cloud and AI.

But in the GMP areas, we have just started digitising things. AI will be adapted there, too. Again, to test or validate AI, we need a lot of time and documentation because AI implementation can’t be done in one go. AI might give you 50% accurate output after the first training. If you train again, it may provide 55% accurate output. But it will not give you 100% accurate output easily. AI has to evolve because production batches impact patients. AI will evolve, but not immediately in GMP; it will take some time.

Pharma Now: It is very accurate. Let me redirect the conversation a little: You currently work at Lambda, which is a 1200-person company and spread across five countries. As a CIO, how do you manage this workforce while sitting in one location?

Mr. Singh: Currently, our headquarters are in Ahmedabad. We have most of our bio-analytical labs in Ahmedabad, where we do R&D. Additionally, method transfer from one location to another is possible. Lambda is a CRO. We do Phase 1 studies on healthy volunteers and also perform Phase 2, 3, and 4 studies, which are patient-based. Patient-based studies are mainly done for our sponsors. Most pharmaceutical customers are our sponsors, and many customers look for multi country studies. Regulatory bodies expect us to have an equal set from the population to participate in clinical studies. For example, if I am performing a breast cancer study and market my India-manufactured product in Indian, US and European markets, regulatory bodies expect us to have people from India, Europe and US participate in the study. So, when we test the drug on people, we need to implement solutions to test the product to ensure they are accessible for all hospitals where our clinical research coordinators are present. So that they can enter data directly into the software from hospital sites, and we will get real-time data in India and do analytics. We are slowly moving toward cloud. So that we can cater to multiple geographies, sponsor demand, and manage multi-country studies.

Pharma Now: Since you are implementing cloud in your systems, can you share what your key priorities for cloud and cloud computing are?

Mr. Singh: One first that we look for when implementing cloud is security. The second thing is data compliance, which is a very, very critical thing. If I want to conduct studies in Europe, the EMA requires that we be compliant with General Data Protection Regulation (GDPR), compliant data. So, some questions arise, for example, where exactly is your cloud hosted? Which region is the cloud in hosted? Because the EMA wants European customer data to stay in Europe. Hence, you have to look for a particular partner that is compliant with these regulations and can provide a security solution with no performance challenges. So, these are the two points that we consider when implementing cloud.

Pharma Now: Understandable, Mr. Singh. Talking to you about various aspects of digital transformation and your journey was incredible. Thank you for joining us at Pharma Now and sharing your insights, expertise and thoughts.

Mr. Singh: Thank you.