Step-by-Step Guide: Achieving Desired Outcomes through Digital Labeling

Labeling in the pharmaceutical industry has grown increasingly complex as products move faster across more markets, formats, and lifecycle stages. What was once a largely document-centric activity has evolved into a continuous process that must respond to regulatory updates, safety signals, and real-world usage insights. As a result, maintaining pharma labeling compliance is no longer only about accuracy at the point of approval, but about sustaining correctness over time.

Many organizations still rely on fragmented systems, market-specific trackers, and manual reconciliation to manage label changes. These approaches often make it difficult to understand why a particular wording decision was made, how it evolved across markets, or whether downstream materials remain aligned. This lack of traceability introduces both operational risk and regulatory exposure.

A digital label for pharmaceutical products begins to address these challenges by shifting labeling from static documents to structured, data-driven assets. When label content is treated as governed data rather than isolated files, organizations gain clearer lineage, improved auditability, and greater control over change propagation. This shift does not replace regulatory judgment, but it strengthens the infrastructure that supports it.

By framing labeling as a lifecycle discipline rather than a series of discrete tasks, companies can better align regulatory intent, operational execution, and patient communication.

The industry has started to take action to automate the cumbersome and highly manual process while it continues to strive toward digitized and electronically accessible labeling information. A number of changes have started to take place due to policy updates, industry initiatives, and advocacy demands demonstrating that improvements are starting to take shape.

Across the industry, progress toward digital labeling is uneven and often incremental. Many organizations begin by automating isolated tasks such as formatting, quality checks, or artwork updates. While these steps reduce manual effort, they do not fully address the underlying structural challenges of labeling operations.

More mature approaches focus on integrating regulatory labeling automation services into the broader regulatory and content ecosystem. This includes aligning authoring, review, submission, and post-approval change management around shared data standards. In these models, automation supports consistency and compliance rather than simply accelerating document production.

Digital labeling, in this context, is not a single technology implementation. It reflects a shift in how labeling content is created, governed, and reused across markets and channels. Organizations that adopt this mindset are better positioned to respond to regulatory changes, support electronic labeling initiatives, and maintain control as volumes and complexity increase.

Vladimir Penkrat who heads Regulatory Affairs at Indegene along with Dr Sonica Batra who heads Regulatory Operations at Indegene recently sat down with an audience of industry leaders to discuss experiences and best practices to drive toward a future ready labeling operation.

Challenges related to labeling are not new in the industry. More than 50% of medication errors occur due to drug labeling. Between January 2017 and September 2021, most recalls were of pharmaceutical drugs, accounting for 85.2% of all recalls. Each year, 134 million adverse events occur in hospitals due to medication errors that resulted in 2.6 million deaths.

To improve accuracy and timeliness of label information there are legislations that are triggers for change for example, there is ongoing work to improve communication with patients through electronic product information (ePI). ePI is the EU common standard developed with the goal of expanding public access to accurate and up-to-date information on medicines, labeling, and package leaflets. This includes a pilot program in Belgium and Luxembourg that is being run in collaboration with the pharmaceutical industry and regulatory authorities. This program aims to create new electronic labeling for human prescription drugs, known as Electronic media in prescription drug labeling. ePI is also anticipated to improve patient safety and health systems’ resilience. This is because electronic labels can be easily updated with the latest information, and healthcare professionals and patients can easily access them. They can also be used to create unique identification codes, which can help combat counterfeit products.

From an operational perspective, electronic labeling changes how regulatory teams manage both content and risk. Unlike traditional paper-based approaches, electronic labeling enables faster updates, clearer version control, and improved alignment between approved content and what is ultimately accessed by healthcare professionals and patients.

When label information is structured and digitized, regulatory teams can better manage dependencies across markets and formats. Updates triggered by safety changes or regulatory feedback can be assessed centrally and propagated with greater confidence. This reduces the likelihood of divergence between local labels and the global reference, a common challenge in complex portfolios.

Electronic labeling also supports more consistent interpretation of regulatory requirements. By standardizing how information is represented and exchanged, organizations reduce ambiguity in implementation. This directly contributes to stronger pharma labeling compliance by making it easier to demonstrate control, trace decisions, and respond to inspections or inquiries.

As health authorities continue to explore electronic and digital channels for product information, organizations that have already invested in structured labeling foundations will find it easier to adapt. In this sense, electronic labeling is both a compliance enabler and a long-term resilience strategy.

To digitize and standardize label information similar to the European Medicines Agency (EMA) initiative in ePI, some health authorities are accepting label information by applying Structured Product Labelling which is a document Extensible Markup Language (XML) standard approved by Health Level Seven (HL7) and adopted by the FDA to allow for more standardized exchange of product and facility information. The benefit of these data centric constructs allow for a standard to be formulated so that data exchange can be more effective.

The shift toward digital labeling is not occurring in isolation. It reflects broader changes in how regulators, healthcare professionals, and patients expect to access and use information. These expectations place new demands on labeling organizations, extending beyond submission readiness to ongoing usability and accessibility.

Future demands in labeling are therefore closely tied to how well organizations can manage content as a living asset. A digital label for pharmaceutical products must support rapid updates, consistent language, and controlled reuse across channels. Achieving this requires alignment between regulatory strategy, operational processes, and enabling technology.

The following demands highlight how labeling functions are evolving from reactive execution units into proactive stewards of product information.

As Health Authorities around the world are constantly updating their guidelines and regulations, it is becoming imperative for companies to keep up. Additionally, the industry is under increasing pressure to improve efficiency and reduce costs, while also maintaining the highest standards of quality. The future of labeling in the life sciences industry is likely to be shaped by several factors, including advances in technology, changes in regulations, and the evolving needs of customers. Some of the key demands that are likely to emerge include:

The need of the hour demands a global labeling organization that makes use of technology to improve the ability to track and manage label updates both centrally and for each market, while the industry turns the focus toward effective label language and improved access to good label information for patients and HCPs. Digital labeling is demonstrating strides. For example, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) website allows for barcode access to the contents of the package insert with a smartphone and will eliminate paper versions of package inserts by April of 2023.

While the industry continues to improve label operations, there is an increasing focus on patient needs to ensure that labeling information and communication is future ready. This means taking steps to ensure readability of patient information as well as reducing the number of labeling templates.

In order for an organization to take initiative in this area, improvements in organizational resources are to be made with clearly defined responsibilities and communication pathways. Once you have clarified this, the creation of effective processes and optimal use of technology come together to enable a future ready labeling business.

A five steps framework for process redesign can be applied. It can identify the key areas where improvements can be made in labeling processes. This includes identifying failure points around people, process, and technology, and then mapping the labeling process to identify opportunities for automation.

Each step in the five-step framework plays a distinct role in enabling sustainable digital labeling.

Identifying failure points helps organizations understand where manual effort, unclear ownership, or system limitations create risk. Mapping the labeling process provides visibility into handoffs and dependencies that are often hidden in day-to-day execution.

Prioritizing target needs ensures that investments in digital labeling are aligned with regulatory and business objectives, rather than driven by isolated pain points. Evaluating industry opportunities allows teams to learn from emerging practices without adopting solutions prematurely.

Finally, executing a labeling technology roadmap creates a structured path toward scale. This roadmap should include not only technology milestones, but also governance, training, and performance measurement. Together, these elements support consistent pharma labeling compliance as complexity increases.

Ultimately, the goal of implementing change initiatives in the labeling business allows for an effective roadmap toward digital approaches to reduce medication errors and improve the patient experience.

Digital labeling solutions are designed to improve the efficiency and effectiveness of the labeling process. One can avoid challenges by focusing on the following objectives:

Sustained success in digital labeling depends on viewing it as a core capability rather than a one-time initiative. This capability mindset emphasizes continuous improvement, cross-functional alignment, and measurable outcomes.

Organizations that adopt this approach often define clear KPIs related to compliance, cycle time, and quality. Over time, these metrics help demonstrate how digital labeling contributes to both regulatory confidence and operational efficiency.

By grounding transformation efforts in capability building, companies can ensure that digital labeling remains adaptable as regulations, technologies, and patient expectations evolve.

In conclusion, digital labeling is becoming increasingly important in the life sciences industry, allowing companies to comply with changing regulations and improve efficiency. Companies need to be aware of the challenges, future demands, and industry initiatives driving this change and take action accordingly. This includes process mapping, investigation, technology assessment, implementation, and objectives to outcomes. With the help of digital labeling, companies can ensure compliance, reduce costs, and improve quality control, ultimately helping them to stay competitive in the industry.

As you explore the benefits and challenges of digital labeling in the life sciences industry, we encourage you to connect with our subject matter experts. They can help you with your specific challenges and develop a plan to move successfully ahead with digital labeling. Do not hesitate to reach out and schedule a consultation today.