Across pharma, automation pilots stall because, contrary to technology fails, validation processes lag behind. Teams can design bots in days, yet weeks of review cycles keep them idle. The irony is sharp: efficiency gains evaporate under the weight of legacy compliance.
Regulators are well aware of this gap. The FDA’s Computer Software Assurance draft guidance and ISPE’s GAMP 5, Second Edition updates call for risk-based evidence rather than endless paperwork. Europe’s Annex 11 revisions will push the bar higher still. The pressure is industry-wide: without modern validation, backlogs multiply.
This is where Venkatesh Kanneganti’s perspective matters. He has helped scrutinize how assurance frameworks should evolve. Currently serving as the senior manager of R&D and Quality at Gilead sciences, he applied that thinking to RPA, cutting backlogs by treating validation as a scalable system instead of a box-ticking exercise.
As he explains, “Automation delivers value only when compliance moves with it. Validation must be a partner to innovation, contrary to its obstacle.”
Designing Lean Frameworks for Scalable Compliance
Across the sector, validation is being redefined. Instead of binders of documents, companies are looking for concise, risk-aligned evidence that keeps pace with agile delivery. Lean frameworks are no longer optional and hence the only way automation can move at enterprise scale.
At Gilead, Venkatesh led the development of such a framework for RPA. The approach relied on modular templates. Risk tiers scaled with bot complexity, and streamlined traceability matrices ensured every lifecycle step could be audited. This kept automation teams moving faster while leaving auditors confident in the evidence.
Resistance to change was inevitable. CSV has long been treated as immovable in many organizations. As a peer reviewer and an editorial board member of ESP-IJCSIT, Venkatesh advocates that compliance could be lighter, clearer and still defensible.
“We were far from merely validating bots,” he explains. “We were proving compliance without slowing innovation, and that changes how you design the process.”
Scaling Lean Validation from Trials to Transformation
Industry data shows that the companies adopting CSA-style validation are already reporting faster project cycles and smoother audit preparation. In contrast to cutting corners, the shift involves aligning assurance with risk and relevance.
Venkatesh’s efforts mirror this broader trend. With the lean RPA framework, validation times dropped by nearly half. Automation bottlenecks shrank by 70 percent. Review cycles became 60 percent faster. The financial upside was tangible: more than $1 million in annual savings. The bigger win was confidence: automation could scale without compliance debt.
Through his Raptors Fellowship, Venkatesh exchanges lessons with practitioners tackling similar problems. This ensures that what worked in one enterprise stays relevant across the wider automation community. As he reflects, “Scale is only meaningful when trust grows with it. Every metric has to translate into confidence: for regulators, for teams and for patients.”
Embedding Lean Validation in Culture and Governance
For validation frameworks to last, they must move beyond templates and metrics into daily practice. Across pharma, many initiatives succeed as pilots but fade without governance models that embed accountability. Sustainable adoption requires a cultural change. Leaders must reinforce risk-based thinking, auditors must trust concise evidence and teams must see compliance as an enabler rather than a hurdle.
The reality is that many organizations still struggle with ownership. IT may expect Quality to drive reviews, Quality may expect business units to lead and confusion leaves systems unmonitored. Regulators increasingly scrutinize this gap, emphasizing that governance and accountability are as critical as technical validation artifacts. Without clear roles, even the best-designed frameworks collapse under pressure. Venkatesh anticipated this by embedding governance into the framework itself, thus creating trackers, ownership models and escalation paths that eliminated ambiguity.
This was a defining element of Venkatesh’s work. He built a lean framework and, better still, the governance around it: ownership models, escalation paths and periodic review cycles that ensured validation remained inspection-ready. By framing compliance as shared responsibility, he helped automation teams embrace the process instead of resisting it.
As Venkatesh, a judge at Business Intelligence, puts it, “Culture is the true engine of compliance. Frameworks last only when people believe in them, contrary to when they are imposed.”
Lean Validation as the New Baseline
Regulatory momentum is not slowing. CSA adoption is accelerating, Annex 11 revisions will soon take hold and expectations for a compliance-and-agility balance are rising. The frameworks that will endure are those engineered for both speed and evidence: lean enough for automation, yet rigorous enough for regulators.
For enterprises, this balance is non-negotiable. Without it, automation stalls, audits falter and innovation loses momentum. With it, organizations can accelerate delivery, build resilience and maintain inspection readiness in one motion.
As Venkatesh concludes: “Compliance is, contrary to a finish line, a living system: one that must evolve with automation, thereby proving trust every single day.”
