Across life sciences and medical devices, 2024–2025 marked a practical turning point as the FDA's Computer Software Assurance (CSA) framework moved from draft to final, clarifying how to right-size assurance for software used in production and the quality system while maintaining the statutory guardrails of 21 CFR Part 820 and related requirements for data integrity and patient safety.
The final guidance emphasizes four key steps: intended use, risk determination, appropriate assurance activities, and maintaining accurate records, marking a shift away from the exhaustive retesting and screenshot-heavy documentation routines associated with traditional Computer System Validation (CSV) toward a more scalable approach that aligns with risk profiles.
This matters because the software landscape has changed: cloud services, configurable platforms, and AI-enabled tools are now integrated into manufacturing and quality workflows, demanding a framework that encourages adoption while preserving inspection readiness and safety outcomes. Industry forums and quality associations in 2024–2025 echoed the same imperative: elevate testing where it counts, leverage supplier deliverables transparently, and apply data-centric evidence models that reduce administrative burden without eroding the audit trail.
Korrapati's Remit and Record
Within this policy context, Korrapati operates as Senior Supervisor for Software Quality, where she provides quality oversight for a large suite of GxP applications and leads the transition from CSV to CSA for IT systems that touch production and quality processes, aligning assurance rigor with the functions that bear on patient and product safety. Her mandate includes ensuring that software and digital controls adhere to Part 11 and Part 820 expectations while shifting teams toward risk-based testing, supplier qualification, and right-sized records that remain inspection-ready, a rebalancing that frees capacity for targeted exploratory and scenario-based tests.
Korrapati's implementation work is complemented by industry engagement, including presenting on CSA implementation and roadblocks at professional venues and contributing to guidance reviews through associations such as ISPE and the regional quality community. These efforts collectively shape practitioner-level norms for risk-based approaches beyond a single firm. She has also published on validating AI in GxP contexts, arguing for "trust but verify" practices that blend model risk assessment with classical validation and continuous monitoring techniques to maintain confidence over time.
From CSV to CSA: What Changed
The CSA guidance codifies a practical redistribution of effort: it permits manufacturers to leverage vendor testing where appropriate, adopt unscripted and ad hoc testing for low-risk features, and reserve scripted testing for high-risk functions with direct impact on patient safety or product quality, thereby aligning evidence with consequence rather than with habit or fear of audit findings.
For organizations modernizing their validation playbooks, CSA's least-burdensome principle does not dilute expectations; it clarifies them by anchoring documentation sufficiency in risk analysis and intended use, a stance reiterated by regulatory analysts who note that Section 6 of the 2002 validation guidance is now superseded for production and quality system software, while core Part 820 obligations remain intact. The practical upshot is fewer redundant tests, better utilization of supplier audits and certifications, and assurance packages that are lighter where risk is low and deeper where failure would be consequential.
The Reallocation of Efficiency
Korrapati's teams have applied these principles to reduce unnecessary repetition and prioritize risk-centric test design. This change has resulted in shorter cycle times for change implementation and more precise traceability to hazards of consequence. She describes the goal succinctly: "The discipline is not lighter—it's smarter," a position aligned with the FDA's own language, which asserts that assurance should be no more burdensome than necessary to manage risk while fostering the uptake of modern tools in production and quality systems.
Her operational focus extends to complaint handling improvements, where a VBA-based automation reduced review time and created capacity for higher-value analysis. In regulated environments, those time savings compound: each avoided redundant test frees scarce expertise to interrogate edge cases and atypical workflows, the areas most likely to surface latent defects that matter under clinical or manufacturing stress.
Guardrails and Skepticism
Not everyone is sanguine about the pace of change, and several quality professionals have cautioned that trimming documentation without a mature risk culture can lead to brittle assurance packages that are difficult to defend during inspections. One critic put it bluntly in a recent panel: "Efficiency is admirable until it obscures evidence," urging teams to prove their risk rationales are reproducible and to maintain robust supplier oversight as they rely on vendor testing.
Korrapati acknowledges the point and frames the solution within CSA's own logic: formalize critical thinking, document why a method fits the risk, and ensure that electronic records are captured as evidence, techniques that both the FDA and quality associations have highlighted as valid and often superior to screenshot-driven scripts. Her stance mirrors the guidance's insistence on maintaining appropriate records, which are sufficient to demonstrate fitness for the intended use and decision-making rigor. Still, not so much that documentation becomes an end in itself.
Numbers With Restraint
Forecasts for validation and assurance services indicate steady expansion through 2030 as companies refactor their quality stacks for cloud and AI, with market notes in 2024–2025 flagging a shift in spending from legacy CSV labor toward risk-based methods, toolchains, and supplier qualification that align with CSA principles, albeit with variation by segment and geography. Analysts and solution providers in 2025 described the guidance as a modernization that will drive adoption curves in digitized manufacturing and eQMS workflows, particularly where configurable platforms and automated data processing systems dominate.
Still, quantitative claims are best treated as context rather than headline: the salient reality is that firms that master risk-based assurance will likely ship compliant changes faster and with more explicit safety focus, advantages that show up in lead times, audit observations, and the opportunity cost of tying up engineers in paperwork instead of purposeful testing. By that measure, Korrapati's program is an organizational design choice as much as a compliance project.
AI, Data, and the Next Mile
Korrapati's publication on validating AI in GxP systems aligns with CSA's emphasis on continuous assurance and fitness for intended use, advocating for explicit model risk assessments, data lineage controls, and monitoring plans that prioritize concept drift and real-world performance as primary validation concerns, rather than afterthoughts. In practice, this means pairing pre-release testing with post-deployment signal detection, integrating quality monitoring into the assurance record, and establishing change control that recognizes model retraining as a validation-relevant event.
Industry conference agendas in 2024–2025 likewise featured sessions on harmonizing CSA with updated clinical quality frameworks and on replacing screenshot-heavy evidence with audit-trail and data-centric methods, underscoring that the cultural shift is as much about how evidence is captured as about how much of it is generated, with practicality and data integrity as the governing criteria. For surgical robotics, where digital transformation meets clinical impact, this synthesis is not optional: it is how quality keeps pace with innovation while remaining transparent to regulators and safe for patients.
A Leader's Imprint
What distinguishes Korrapati's contribution is not only the adoption of CSA but the translation of its abstractions into repeatable routines: risk-ranking functions tied to patient or product impact, tailoring scripted versus unscripted testing accordingly, and drawing vendor artifacts into the record through supplier qualification so that duplication yields to traceable reliance, all in line with the FDA's final guidance. Her oversight of a broad GxP application estate ensures the approach scales across categories, making the program a platform for consistent, risk-aware assurance rather than a set of isolated pilots—a hallmark of durable change.
Her peers' feedback loops, such as conference presentations, guidance reviews, and shared methodologies, have helped spread these practices beyond a single enterprise, contributing to a community of practice that refines how CSA is applied in real systems with real constraints. The arc is familiar in regulated technology: policy sets the terms, but leaders make it work, and in doing so, they reset expectations about what quality can be when it is grounded in risk and executed with rigor.
Setting the Standard for Regulation
"Regulation can set a floor, but leadership sets the standard," Korrapati reflects, describing the work ahead as embedding risk-based judgment so deeply in teams that it becomes habit, not heroics. This formulation echoes the FDA's shift from validation as a one-time event to assurance as a continuous approach, grounded in intended use and evidence that aligns with the stakes.
