Innovation has been at the heart of our growth journey

Sekhar Surabhi, CEO & Founder, Caliber Technologies and Director, ISPE India Affiliate, Chair, ISPE Pharma 4.0, Community of Practice (CoP), talks about his company’s journey, shares lessons on resilience, Pharma 4.0 adoption, and the future of AI in regulated environments, in an exclusive interaction with Express Pharma

As Caliber completes 25 years, what core principles or practices do you feel have helped the company stay resilient and relevant in such a fast-evolving industry?

At Caliber, resilience has largely come from staying anchored to quality, integrity, adaptability, and innovation. These are like pillars of our foundation. In pharma, compliance and patient safety can’t really be compromised. Hence, we chose early on to stay aligned with global regulatory thinking, to invest ahead of the curve in technology innovation, and to build long-term trust with clients rather than chase quick wins.

Internally, we have tried to nurture a learning culture, where our teams continuously upgrade their expertise and have space to experiment to match the industry’s pace. These values reflect across our portfolio spanning Laboratory, Quality Management, Manufacturing, and Data & Insights, with each solution built to anticipate change while remaining rooted in compliance.

Pharma companies are navigating a rapidly changing environment. From your perspective, how are the expectations of industry shifting, particularly in areas like compliance, operational agility, and digital adoption?

What I notice is a shift from compliance as an ‘obligation’ to compliance as an advantage. Increasingly, industry leaders don’t just want systems that satisfy regulators; they expect platforms that actively accelerate market delivery, strengthen decision-making, and make audits almost effortless. What was once about managing compliance in silos has now evolved into a demand for integrated, predictive, and intelligence-driven ecosystems that connect the enterprise end to end.

Companies are seeking agility by design — platforms that evolve in step with regulatory change, create a single source of truth across operations, and transform compliance into a lever for competitiveness. In my view, the conversation has decisively moved from digital tools that just transact to digital ecosystems that transform. Done well, compliance doesn’t slow the business down; it becomes the foundation for speed, confidence, and long-term resilience.

Serving a highly regulated industry brings unique challenges. Could you share some of the practical hurdles you’ve encountered and how Caliber has built credibility and trust with clients?

One consistent hurdle has been the perception that digital systems create complexity rather than reduce it. Clients worry about validation, regulatory acceptance, and integration with legacy systems. We have addressed this by making sure every Caliber solution is compliance-by-design, aligned with international regulatory standards and guidelines like ICH and ISPE, and validated in ways that stand up to scrutiny.

Beyond technology, trust really comes from standing with our clients during inspections and audits, ensuring they feel supported. Over time, our solutions like CaliberLIMS, EMPro, Electronic Batch Records, and EPIQ by Caliber have demonstrated how digitalization can reduce human error, improve traceability, and simplify inspections. That real-world value has been central to building credibility with auditors for the compliance focus.

Expectations around analytics and reporting have advanced significantly. What kind of insights or tools are pharma clients seeking today that are different from even five years ago?

The industry has moved from wanting to record the past to wanting to predict the future. Five years ago, dashboards and digital records were enough. Today, leaders demand predictive analytics, real-time visibility, and cross-functional intelligence.

They want connected insights that link labs, quality, and manufacturing into one transparent layer. At Caliber, we anticipated this shift and built solutions like QUARI for instant actionable regulatory insights, CaliberAPQR for anytime product quality reviews, CaliberCPV for continuous process verification, CaliberPulse for advanced statistical analysis, and CaliberMetrix for quality metrics. These tools do not just report — they empower companies to make better, faster decisions with confidence.

In your role as Chair of ISPE India CoP for Pharma 4.0, what priorities are you focusing on to help the industry move forward meaningfully?

My focus is on building an ecosystem of collaboration. Pharma 4.0 cannot be achieved in isolation. It requires regulators, manufacturers, and solution providers to align. At ISPE India, we are working on knowledge-sharing platforms, maturity benchmarking, and frameworks tailored for SMEs so that adoption becomes scalable. I am also prioritizing digital validation, data integrity by design, and workforce upskilling, because transformation must be both technical and cultural. The goal is to help India not just follow global frameworks but also contribute models that are globally relevant while locally feasible.

From your perspective, where does Indian pharma currently stand on the Pharma 4.0 maturity curve, and what barriers do you see most frequently across organisations?

I would say India, and much of the world, is in the early-to-evolving stage of Pharma 4.0. A few pioneers have achieved significant maturity, but widespread adoption is still uneven. The barriers are clear: a mindset that treats digitalization as an IT project rather than a business transformation, reliance on fragmented legacy systems, and resource constraints in smaller firms. Integration is often the missing link.

However, what encourages me is the shift in intent. There is now a broad acknowledgment across the industry that Pharma 4.0 isn’t optional — it’s inevitable. That intent is the first step toward acceleration.

Looking ahead, how do you envision Caliber’s role in enabling Pharma 4.0 adoption — not only through technology but also by contributing to broader industry capability-building?

I see Caliber playing a dual role. First, through our digital platforms across labs, manufacturing, quality, and data & insights, we provide the foundation for predictive quality. Second, we see ourselves as a knowledge partner: contributing to shaping best practices and mentoring organizations on their journey. Pharma 4.0 is as much about culture and capability as it is about technology. Our role is to bridge all three.

You mentioned innovation is one of the key pillars of Caliber. How did it help the industry and also Caliber to grow?

Absolutely. Innovation has been at the heart of our growth journey. Nearly 25 years ago, we were among the first two companies to bring web technologies into the pharmaceutical industry. This dramatically reduced validation time and helped shorten product timelines — a real shift for the sector back then.

We were also the first in India to implement a paperless laboratory. What began as a pioneering initiative has now scaled to more than 50 labs, fully integrated with diverse instruments and ERP systems. The result is faster audits, stronger auditor confidence, and a higher assurance of data integrity. Many of our customers often share how their audit outcomes improved, with auditors appreciating the robustness of their systems.

At our recent user forum, Commune, we launched nine new innovations designed to deliver tangible value to our users. Our customers now eagerly look forward to each edition of Commune to see ‘what’s next.’ Looking ahead, we are placing strong emphasis on AI and ML —technologies we believe will redefine how pharma approaches quality and efficiency.

As you talked about AI and ML, these tools rapidly enter the pharma landscape. What do you see as their most practical applications in regulated environments and where should companies exercise caution?

AI and GenAI already have early-stage use cases in areas such as automating documents, simplifying data handling, and supporting validation. These applications bring clear efficiency gains without raising compliance concerns. But when it comes to critical decisions, such as batch release or patient safety, technology can’t replace the need for validated systems and human oversight. The balance is in using AI to remove routine burdens while keeping human judgment at the center of quality and compliance.

At Caliber, we are preparing for this future responsibly. We have already introduced CalGenie, our GenAI solution for master data creation, and we are building readiness across our wider portfolio — including LIMS, Batch Record Management, and Data & Insights — to leverage AI in ways that augment human expertise while safeguarding compliance. The guiding principle is simple: AI must serve as an enabler, not a risk.

Having spent 25 years building solutions for pharma, what lessons stand out to you about how innovation and compliance can co-exist without one slowing down the other?

The most important lesson is that compliance and innovation don’t have to be at odds — they can reinforce each other. Compliance builds the trust on which pharma rests, while innovation creates the efficiency and scalability needed to thrive.

At Caliber, when we built solutions, we always started with compliance as the foundation and layered innovation on top. That approach allows companies to adopt faster, with less risk, and with outcomes that last. For me, compliance isn’t a hurdle — it’s the bedrock that makes innovation meaningful and sustainable.