Quality teams are often told to "move faster" and "never break compliance."
It's a catch-22. And for most, it leads to delays, stress, and systems duct-taped together for audits. But Pranesh Srinivas approached it differently.
He ran 500+ GLP audits a year, built a lab from scratch, and cut non-compliance incidents by 25% with a QMS overhaul. He's leading efforts to fuse AI, digital twins, and FDA-aligned frameworks into validation systems that scale and stay inspection-ready.
This article breaks down how he did it, from creating modular lab systems with no equipment to transforming fear-based audit cultures into high-performing teams.
A Scientific Mindset from the Start
Before audits. Before protocols. There were just questions.
What drives adaptation? How does biology respond to stress? These weren't just academic curiosities; they were real-world puzzles. Pranesh leaned into them through zoology, where every answer led to a better experiment, and every experiment demanded precision.
That mindset never left him. From fruit fly studies in Bangalore to validation systems in multinational labs, the pattern was clear: whether you're tracking Drosophila behavior or designing software pipelines, good science means sound systems. And systems, when built right, serve both data and people.
At Advinus: Compliance as a Competitive Edge
Between 2007 and 2010, Pranesh entered the regulatory deep end at Advinus Therapeutics. As a research scientist, he executed over 500 GLP audits yearly across toxicology and microbiology, embedding quality into daily workflows rather than leaving it to the end.
But his breakthrough wasn't just in volume. He digitized SOPs, reducing audit prep time by 30%. He introduced a Quality Management System that cut non-compliance by 25%. He also trained auditors in a way that boosted capacity by 20%. He even remembers the first inspection where digital files replaced paper binders, a small change that felt like a tipping point.
By the end of his tenure, Advinus held certifications from Germany and the Netherlands National Authorities. The lab wasn't just compliant, it was confident.
Starting from Zero at Bangalore University
In 2010, Pranesh made an unconventional move: he left a fully equipped lab to build one from scratch.
Armed with a biodiversity grant and a folding table, he set up a Drosophila lab at Bangalore University. There was no centrifuge, no SOPs, no roadmap—just an idea and a willingness to make things work. He remembers the refrigerator humming too loudly in those first months, but it kept samples cold. That was enough.
Over four years, he trained students, validated procedures, and published nine peer-reviewed studies. More than that, he built a modular, enduring system that outlasted the project and anchored future research. He earned his PhD. But what he really earned was proof that resilient systems start with intentional design.
Raising the Bar at Jubilant Biosys
By 2013, Pranesh was ready to go bigger, this time with a company culture.
At Jubilant Biosys, GLP readiness was inconsistent. Instead of patching gaps, he rebuilt the framework. He introduced end-to-end SOP development, ran company-wide training, and optimized infrastructure to align with OECD GLP standards.
One pivotal moment? When a junior team member, once anxious about inspections, volunteered to lead a mock audit. That's when Pranesh knew the mindset had shifted.
Within a year, Jubilant earned NGCMA certification. What had been a regulatory hurdle became a business advantage.
Turning Compliance into Market Strategy at IQ4I
In 2014, Pranesh pivoted. From labs to boardrooms. From inspection checklists to business foresight.
At IQ4I Research & Consultancy, he turned regulatory complexity into actionable strategy, forecasting risks, benchmarking competitors, and distilling market insights into narratives that made sense to stakeholders. At first, applying lab logic to business models felt like using a microscope to navigate traffic. But he widened the lens and found clarity in the patterns.
From Systems to Scale: Indegene, PointCross, GalaxE
By 2016, Pranesh was at the frontier where quality meets digital.
At Indegene, he improved KPI monitoring in ISO-certified environments. At PointCross, he integrated QA into an agile scrum framework under computer system validation, maintained ISO 9001:2015 and ISMS 27001:2013 certifications. And at GalaxE Solutions, he guided a complex migration of legacy systems into a regulated safety platform, reducing computer system validation errors by 20%.
Validation wasn't just documentation anymore. It was architecture. It was quality by design.
Where QA Meets AI: A New Chapter Begins
In 2021, while at Roche, Pranesh led the rollout of a self-monitoring CSV framework—software that flagged risks in real time and cut revalidation cycles by 15%. That success raised a bigger question: what else could systems learn to do on their own?
He continued to explore the answer at Cognizant Technology Solutions, supporting enterprise-wide validation of pharmacovigilance systems using advanced tools like ValGenesis.
Now, at IQVIA, he's working on intelligent validation platforms powered by AI, edge computing, and digital twins. These systems simulate clinical environments, detect failures before they happen, and deliver decentralized, audit-ready data.
He follows FDA and EMA guidance, anchored by ISPE GAMP 5, to ensure transparency and defensibility. Because in a world of learning machines, the real innovation is trust.
Pranesh Srinivas is widely recognized as a top-tier expert in quality assurance across LifeScience, Pharmaceuticals, and Clinical Research Organizations. His contributions go far beyond compliance checklists—they're vital to the systems that protect patient safety, ensure regulatory alignment, and uphold public trust. In a highly scrutinized and regulated industry, his work forms the backbone of operational integrity, safeguarding everything from clinical trial data to market-ready pharmaceuticals. By translating technical validation into scalable, defensible frameworks, he helps organizations not only meet regulatory demands but also build lasting credibility and brand resilience.
Why This Matters, Now
If you're in life sciences today, you're likely asking:
- Can we modernize with AI and cloud platforms, without compromising compliance or data integrity?
- How do we manage inspections across hybrid teams and global infrastructure?
- Where do we even start with intelligent validation?
Maybe you're rolling out a new EDC system. Or prepping for an inspection with half your team remote. These aren't edge cases anymore, they're your Tuesday.
Pranesh's story isn't just inspiring, it's instructive. It shows that digital transformation and regulatory rigor can co-exist. That quality can scale. That foresight can be built into the system.
The future of quality won't be more paperwork. It'll be systems that adapt with science.
About the Author
Neel Anand is a science and technology writer who specializes in life sciences, digital health, and regulatory innovation. With a background in clinical operations and a passion for translating complex systems into compelling narratives, he's profiled leaders at the intersection of biotech and emerging tech for over a decade.
