The Four Stages of Digital Maturity
1. Reactive
High Risk, Limited Visibility
Life sciences organizations at the Reactive stage often rely on manual processes and disconnected systems.
Regulatory submissions and labeling updates are handled through emails, spreadsheets, and file shares, increasing the likelihood of errors, rework, and even non-compliance findings.
Decisions are tactical, collaboration is limited, and approval cycles are slow, which puts both revenue and patient safety at risk.
Example: In late 2024, an anxiety medication was recalled after cartons displayed the wrong strength. Though the inner packs were accurate, the labeling error delayed distribution and highlighted how manual approval processes allow critical mistakes to slip through.
2. Organized
Establishing Control
At the Organized stage, companies begin to centralize workflows and introduce governance. Standard templates and structured review processes reduce errors and enhance traceability.
While much work still happens in departmental silos, the foundation is set for digitization, making compliance more reliable and predictable.
Example: Fentanyl buccal tablets were recalled by the FDA when safety update information was not included in the product insert. This underscores the importance of structured workflows and content control to ensure patient-critical details are never missed.
3. Optimized
Driving Efficiency and Collaboration
Organizations in the Optimized stage embrace cross-functional collaboration.
Regulatory, labeling, packaging, and marketing teams work within connected systems, reducing duplicate effort.
Automation supports faster approvals and fewer errors. With shared visibility across stakeholders, companies can bring products to market more quickly while improving quality and audit readiness.
Example: A retrospective study of FDA recalls found that around 8% were due to labeling errors. These findings exposed the ongoing risks when workflows remain siloed and visibility across teams is limited.
4. Automated & Intelligent
Market-Leading Innovation
At the highest level of maturity, AI- and automation-driven workflows ensure compliance by design.
Real-time insights support predictive decision-making, while connected systems continuously track quality and sustainability metrics.
These organizations are not only compliant — they are industry leaders, setting new standards for speed, efficiency, and innovation.
Example: Life sciences companies are increasingly turning to AI-driven workflows to automatically validate compliance against the latest regulatory requirements. These systems flag discrepancies before they reach human reviewers, reducing cycle times and errors.
How Digital Maturity Impacts Artwork & Labeling Workflows
Every stage of the product content lifecycle — from briefing through supply chain handoff — is impacted by a company’s maturity level.
For life sciences companies, this translates directly into compliance outcomes and patient safety:
Briefing: Structured, collaborative briefs capture all necessary regulatory and product data up front, reducing downstream rework.
Content Creation & Translation: Centralized, integrated systems enable version control, localization, and reuse of approved content, ensuring consistency across global markets.
Artwork Change & Verification: Automated checks and structured approval workflows reduce cycle times while maintaining audit readiness.
Supply Chain: Integrated collaboration tools ensure accurate, compliant files are distributed seamlessly to suppliers.
By advancing digital maturity, life sciences organizations take these workflows from fragmented and error-prone to streamlined, compliant, and future-ready.
Four Strategies for Transformation
No matter where your organization begins, the journey to digital maturity can be broken into four strategies:
- Establish Control (for the Reactive stage): Minimize compliance risk by centralizing processes and creating structured review cycles.
- Build Efficiency (for the Organized stage): Standardize operations and introduce automation to reduce manual errors and accelerate cycle times.
- Accelerate Growth (for the Optimized stage): Enable cross-functional collaboration, reduce rework, and drive speed-to-market to gain a competitive edge.
- Lead the Market (for the Automated & Intelligent stage): Leverage AI, cloud, and connected ecosystems to continuously innovate and anticipate regulatory and patient needs.
Benchmark Your Digital Maturity
Before making further technology investments, it’s essential to understand where your organization stands today.
Using the Esko Digital Maturity Model for Artwork and Labeling guide, life sciences companies can:
- Assess their current digital capabilities.
- Align regulatory, labeling, and commercial stakeholders around a shared vision.
- Develop a phased roadmap to reduce risk and accelerate launches.
- Apply a transformation strategy best aligned with their business goals.
