Manual Workflows Are Costing Millions—Here’s Why They Persist and How Leading Companies Are Eliminating Them

Why structural workflow design, not automation volume, determines financial impact in regulated environments

Life sciences executives enter 2026 under familiar pressure: reduce operating costs, accelerate execution, and strengthen compliance—without increasing risk or burning out already-stretched teams. Intelligent workflow automation is often positioned as the answer. Yet despite years of investment in platforms, AI tooling, and digital transformation programs, many organizations struggle to show durable financial returns.

The reason is not a lack of technology maturity. It is a misalignment between where automation is applied and how value is actually created.

Automation does not generate a material impact simply by doing more work faster. It creates impact by amplifying human judgment in high-cost, high-risk decisions—and by removing the structural friction that prevents people from acting on the information they already have.

This is the premise behind Smarter, Leaner, Safer — Intelligent Workflow Automation for 2026: a pragmatic look at how life sciences organizations can unlock measurable financial value by redesigning workflow architecture rather than just layering on new AI capabilities.

The Hidden Cost Most CFOs Don’t See

Across more than 150 pharmaceutical and biotech organizations, USDM has observed a consistent and costly pattern: IT Quality teams spend 60% or more of their time gathering information that already exists elsewhere in the enterprise.

This is not an efficiency issue. It is a structural one.

In most organizations, IT Quality manages GxP IT changes in QMS platforms such as Veeva Vault, MasterControl, or TrackWise—or in spreadsheets and email. IT Operations executes those same changes in ServiceNow, where system relationships, performance history, incident data, and vendor context already live.

This separation creates what we call the IT Quality Information Vacuum—a persistent gap between compliance accountability and technical reality.

The result is duplicated labor, delayed decisions, conservative risk postures, and missed opportunities to prevent failures before they occur.

Quantifying the Impact: A CFO View

For a mid-sized life sciences company managing approximately 200 GxP IT changes per year, the financial impact is material and recurring.

Annual Cost of the IT Quality Information Vacuum

Industry-wide, this translates to $1.75B–$2.8B in annual waste—costs that rarely appear as line items but consistently erode operating margins.

Why This Problem Has Remained Invisible for Decades

Despite its financial impact, the IT Quality Information Vacuum has persisted largely unquestioned for more than two decades. Several structural forces have reinforced the status quo:

• Organizational silos. In most life sciences companies, IT Operations reports to the CIO organization, while IT Quality reports to the Chief Quality Officer or to Quality leadership. These groups operate with different incentives, priorities, and systems of record. Shared visibility is not structurally designed—it is manually negotiated.
• Vendor economics. Traditional QMS vendors have little commercial incentive to integrate deeply with ServiceNow. Tight integration would reduce user counts, license dependency, and control over regulated workflows.
• Validation cost barriers. Out of the box, ServiceNow is not validated for Part 11. Historically, organizations attempting to use it for GxP workflows have faced $500K–$1M in initial validation costs, plus $200K–$400K in revalidation with each quarterly release. For many, this made architectural change economically unattractive.
• A compliance-first mindset. Organizations typically ask, “Are we compliant?” rather than “Are we effective?” If GxP IT changes pass audits inside a QMS, the operational inefficiency behind them is rarely examined. Compliance becomes the finish line instead of the baseline.

Together, these factors have allowed high cost and inefficiency to hide in plain sight—accepted as simply “how regulated IT works.”

Why Automation Alone Has Not Fixed the Problem

Most automation programs are designed around task elimination: faster document routing, automated approvals, and reduced manual entry.

These gains are real—but they plateau quickly when decision-makers still lack access to complete, real-time context.

AI does not create step-change value by automating everything. It creates value by amplifying human judgment where risk, cost, and impact intersect.

When this happens:

• IT Quality professionals shift from document administrators to risk analysts,
• CABs become predictive instead of procedural,
• and compliance decisions improve in quality while consuming less effort.

This is not workforce reduction. It is workforce amplification—and it is where financial returns compound.

The Platform Question Most Organizations Avoid

The critical question is not which AI features to deploy. It is where IT Quality should operate.

• Product quality workflows (deviations, CAPAs, batch records) belong in a QMS.
• IT quality workflows (GxP IT changes, validation, vendor risk) belong alongside IT Operations.

Separating these domains forces organizations to manually reconcile data that should never be separated in the first place.

A Smarter Architecture: Shared Context, Targeted Control

ProcessX was designed around a simple architectural principle: IT Quality and IT Operations should work from the same system of record, with compliance applied only where required.

Using a GxP routing model: Non-GxP changes flow through standard ITSM, and GxP-impacting changes invoke validated workflows, Part 11 controls, and electronic signatures in ProcessX. Both teams operate with a shared technical context in real time.

This eliminates duplicate work while improving decision quality.

Real-World Impact: SAP Security Patch Example

Time reduction: 81%
Value creation: Faster deployment, lower failure risk, stronger audit posture

Total Cost of Ownership (TCO): Large Pharma Scenario

For a large pharmaceutical organization (10,000 employees, 40 GxP systems, 400 GxP IT changes/year):

Annual savings: $2.03M (≈30%)
Five-year savings: $10.15M
Payback period: ~8 months

Smarter, Leaner, Safer Means This in 2026

• Smarter: Automation aligned to decisions, not tasks
• Leaner: Cost reduction through elimination of duplication, not expertise
• Safer: Better context earlier for the people accountable for risk

AI capabilities will continue to evolve. But the organizations that outperform in 2026 will be those that redesign workflow architecture to amplify human judgment—and can measure the financial value it creates.

The question is no longer whether to invest in intelligent automation. It is whether your current model is quietly costing you millions by keeping critical teams disconnected from the information they need.

Continue the Conversation at the USDM Summit

The financial and operational dynamics outlined here are not theoretical. They reflect patterns that USDM sees across the life sciences industry—and they are actively shaping how leading organizations approach intelligent workflow automation in 2026.

At the USDM Life Sciences Summit, this topic is explored in depth through real-world examples, executive perspectives, and practical frameworks designed for CIOs, Quality leaders, and CFOs navigating the next phase of regulated digital transformation.

Attendees will gain:

• A more transparent financial lens for evaluating automation investments
• Practical guidance on eliminating structural inefficiencies without increasing compliance risk
• Peer insight into how organizations are redesigning workflows to amplify human judgment—not replace it.

If this analysis resonates, the Summit is where strategy moves from concept to execution.

Learn more about the USDM Summit and the Smarter, Leaner, Safer session.