How Catalent Is Reinventing GRC with AI-Ready Architecture

^Problem

Complex Global Operations, Excalating Regulatory Pressure

As a global leader in life sciences manufacturing, Catalent faced increasing regulatory expectations across multiple frameworks, including NIS2, SOC 2, ISO 27001, and NIST 2.0. Ensuring consistent compliance across 51 sites worldwide was becoming increasingly complex.

When Chris Patteson joined Catalent as Director of Cybersecurity – Governance, Risk, and Compliance, he quickly realized that the organization’s traditional GRC tools and spreadsheet-driven processes were not keeping pace. They were slow, fragmented, and heavily dependent on external consultants.

The challenge wasn’t a lack of security maturity, Catalent already had strong controls in place. The real issue was operational scalability: how to manage governance, risk, and compliance efficiently across a highly distributed, highly regulated enterprise without introducing bottlenecks or manual overhead. The need for a modern, centralized, and scalable approach was clear.

^Solution

An AI-First GRC Architecture Built on SmartSuite

At Catalent, Chris Patteson took a bold approach: rather than layering new processes on top of legacy systems, he rebuilt the company’s compliance backbone from the ground up. The goal was clear — a modern GRC foundation designed to handle global scale, cross-framework complexity, AI-driven insights, and site-level variation.

The architecture rests on four core principles:

One Centralized Evidence Repository
Catalent consolidated all evidence into a single structured repository. Controls were mapped through the Secure Controls Framework (SCF) and crosswalked to ISO 27001, SOC 2, NIS2, and NIST 2.0. Integration with systems like AuditBoard and ServiceNow meant no duplicative storage — SmartSuite simply points auditors to the source, shifting the conversation from “Where’s the evidence?” to “What do you want to see? Here’s the system. Here’s the status.”

Wide, Flat, AI-Optimized Data Design
Chris designed large, flat tables with descriptive tagging to make Catalent’s data AI-ready. Instead of relying on rigid relational structures, controls, risks, and evidence can now be interpreted by modern reasoning models. This positions Catalent to layer AI directly on top of structured data, enabling automated evidence suggestion, audit report generation, and other purpose-built GRC models — all without manual engineering.

Federated Scoping Across 51 Sites
Manufacturing compliance is rarely one-size-fits-all. Catalent’s dynamic scoping engines allow assessments at the global, facility, or system level while still tracking enterprise-wide control validation. Whether scoping NIS2 at a single facility or ISO 27001 across multiple sites, SmartSuite ensures no duplication and maintains complete visibility, even when multiple reviewers assess the same control.

Quantitative Risk at the Core
Catalent’s risk register was rebuilt around scenario-based Annual Loss Expectancy modeling. Instead of relying on subjective color-coded heat maps, regulatory and contract risks are quantified in financial terms: potential revenue impact from penalties, contracts at risk without SOC 2, and exposure under NIS2. Risk discussions are now rooted in measurable business impact, driving informed decision-making across the enterprise.


Innovation in Motion

SmartSuite’s evolving capabilities accelerated Catalent’s transformation:

• Bulk control loading and updates at scale
• Dynamic record permissions for auditor-specific visibility
• Scalable architecture to support high-volume record activity
• API flexibility enabling integration with AI model layers

What began as an internal rebuild is now influencing external partners. Industry peers who have seen Catalent’s implementation are beginning to replicate the architecture for their own compliance programs. Chris is now sharing this experience publicly, presenting on “Leveraging the SCF to Bootstrap Your GRC Program”, demonstrating how structured, AI-ready GRC architecture can dramatically reduce implementation time and consultant dependence.

Q1

^Result

Faster Compliance. Stronger Governance. AI-Ready Infrastructure.

At Catalent, what once took weeks of coordination across 51 global sites now happens in a matter of days. Audits that used to rely on fragmented spreadsheets and endless email threads are now structured, data-driven exercises supported by a single, centralized GRC platform. Controls, evidence, and reviews are linked and transparent, giving auditors and regulators immediate visibility without pulling teams away from their work.

By building AI-ready data structures and a federated framework that respects site-specific variations, Catalent has not only reduced reliance on external consultants but has also turned compliance into a strategic advantage. Regulatory conversations are no longer abstract — they’re grounded in measurable financial impact. ISO 27001, SOC 2, and NIS2 readiness are built into the system, and the company can respond with confidence to evolving requirements.

What emerges is more than compliance; it’s an intelligence layer woven directly into Catalent’s operations. The organization can now innovate with assurance, knowing that governance and risk management are not obstacles but enablers of speed, insight, and global consistency. In highly regulated, complex manufacturing environments, Catalent has shown that when GRC architecture is clean, centralized, and AI-ready, compliance becomes a strategic accelerator — not a burden.

Q2