FDA Crackdown Intensifies Need to Harness the Power of AI
With FDA cracking down on promotional materials, there’s never been a better time to implement AI-solutions that precheck content to ensure compliance with government regulations.
Artificial intelligence is no longer an experiment—it’s becoming a core driver of competitiveness across industries. Yet, many organizations are still grappling with the same frustration: dozens of AI pilots that never scale, buzzwords that fail to deliver, and investments that don’t return measurable value.
The lesson is clear: AI innovation must not only be tightly aligned with business needs and corporate readiness. AI must be strategically implemented to address today’s immediate regulatory compliance issues.
Business Needs Anchor AI in Reality Like the recent FDA Crackdown
AI on its own doesn’t generate business value, it’s the problems it solves that matter. Companies that achieve success start with pressing, measurable priorities.
When AI projects are linked directly to business needs—such as maximizing compliance to protect the company from infractions and fines in today’s new enforcement climate – they:
Justify investment with ROI tied to cost savings or revenue growth.
Align stakeholders around outcomes that matter to the enterprise.
Ensure scalability by focusing only on solutions with a clear path to adoption.
This shift turns AI from an experimental playground into a true business enabler.
Why Incremental Innovation Makes Sense
AI is evolving at breakneck speed. But organizations don’t need to adopt the latest technology all at once. This is particularly true when current events demand action.
In fact, the smarter path is often incremental innovation—advancing in practical, manageable steps to bring new tools
Implement a practical use case that build credibility inside the enterprise and begin the journey toward adoption of GenAI
Demonstrate ROI early and often to deliver small, measurable gains to create momentum and justify continued investment.
Scale responsibly across the enterprise with a phased rollout to ensure consistency across business units, agencies, and partners.
This approach matches the pace of organizational readiness, not just technological possibilities.
A Tiered Path to Generative AI
Generative AI has enormous potential—but success depends on timing and trust. A staged adoption model helps organizations unlock value responsibly:
Stage 1: Take One Practical Step
The Important Safety Information (ISI) is sacrosanct and must not contain any errors or deviations from the approved document. Why not start with using AI to verify the ISI instantly
Or, find a solution like SecureCHEK AI that can figure its solution to enable clients to turn on/off GenAI until governance policies are in place
Stage 2: Early GenAI Adoption
Level 1: Think Like a Reviewer. Use AI to pre-check and validate work, catching risks before they reach stakeholders.
Level 2: Think Like a Partner. As trust grows, AI shifts from reviewer to collaborator—drafting content, coaching teams, and offering decision support.
Stage 3: Integration with Ecosystem Partners
Extend AI systems to external agencies and collaborators so everyone operates within the same guardrails—ensuring compliance, consistency, and scalability.
ROI Comes From Business Alignment
Bottom line: The path to AI ROI isn’t about doing more. It’s about doing the right things—in lockstep with the business and corporate compliance, which includes quick response to changes in the regulatory environment
Learn more about SecureCHEK AI by scheduling a short call.
About SecureCHEK AI
SecureCHEK AI is a Software-as-a-Service (SaaS) system that seamlessly integrates with enterprise platforms to enhance MLR efficiency. Purpose-built for pharmaceutical and medical device companies, the software helps MLR reviewers efficiently assess and mitigate compliance risks and reduce comments and re-reviews.
As the first Analytical AI software solution for pre-MLR use in life sciences, SecureCHEK AI leads the way in integrating Analytical AI with GenAI to reduce rounds of review and review time per document. Rapid deployment and the user-friendly interface minimize the learning curve, making it easy to get started.
Contact us for a demo to learn how SecureCHEK AI builds libraries and executes prechecking.