Low-Code Automation in the Pharma Supply Chain: Accelerating Digital Transformation without AI
The pharmaceutical industry, a critical pillar of global health, navigates an exceptionally intricate and regulated environment. From stringent quality controls and complex global supply chains to the relentless pressure for innovation, pharmaceutical companies face a unique array of challenges. In this dynamic landscape, Digital Transformation is not merely an option but a strategic imperative for sustained growth and operational resilience. However, the sector often lags in digital adoption, with less than 20% of companies successfully implementing digital transformation, a notable shortfall compared to the 35% cross-industry average.1 This significant gap underscores a pressing need for accessible, efficient, and compliant digital solutions.
This report will delve into how low-code automation serves as a powerful catalyst for Digital Transformation within the Pharma supply chain, enabling substantial advancements without relying on complex Artificial Intelligence (AI) systems. The pharmaceutical industry’s digital lag presents a significant opportunity. With its promise of faster deployment and lower skill barriers, low-code is uniquely positioned to help pharmaceutical companies rapidly close this digital gap without the heavy investment and specialized talent often required for AI-driven transformation. This implies that early adopters of low-code in pharma could gain a substantial competitive advantage by quickly digitizing processes that their peers are still struggling with, transforming a challenge into a strategic differentiator. We will explore its practical applications, strategic advantages, and its often-overlooked role in addressing emerging challenges like rising sustainability costs, specifically the EU Carbon Border Adjustment Mechanism (CBAM).
The Complex Landscape of the Pharmaceutical Supply Chain
The Pharma supply chain is a labyrinth of interconnected processes and entities, far more intricate than most other industries due to the sensitive nature of its products and the stringent regulatory oversight. Understanding its inherent complexities is crucial to appreciating how Digital Transformation can bring tangible value.
Core Stages and Stakeholders
The pharmaceutical supply chain encompasses a series of critical stages, each with its own set of challenges and requirements. These stages ensure the safe and effective journey of medicines from concept to patient.
- Manufacturing: This initial stage involves the production of drugs and vaccines, often at various global locations based on patient demand. It includes the crucial step of procuring high-quality chemical ingredients and raw materials.2
- Storage: Post-manufacturing, drugs and vaccines necessitate specialized storage facilities to maintain their desired quality. This is particularly vital when dealing with pharmaceutical cold chain products, which require strict temperature control to prevent degradation and ensure quality compliance.2
- Distribution: This phase involves the movement of products with the help of pharmaceutical logistics partners, distributors, and multimodal shippers. The distribution system is responsible for ensuring a steady flow of medicines, calibrating supply to demand, and often taking legal ownership of the products.2
- Retail: The final leg sees pharmaceutical products restocked at retail locations, from where they are dispatched to various pharmacies or directly to patients.2
- Compliance Screenings: Integrated throughout all stages are rigorous compliance screenings, including customs checks at various international nodes, which also serve to detect substandard or counterfeit drugs.2
- Key Stakeholders: The entire ecosystem involves several entities, including manufacturers, suppliers, distributors, pharmaceutical logistics partners, multimodal shippers, and pharmaceuticals retailers.2
Inherent Challenges
The inherent characteristics of pharmaceutical products and the industry’s regulatory environment create significant hurdles that necessitate robust and agile solutions.
- Regulatory Complexity: The pharmaceutical industry is subject to extensive and often varying regional regulations.1 This includes strict compliance norms put in place by governments.2 Key regulatory frameworks include:
- Good Manufacturing Practices (GMP): These are minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use.4 GMP covers aspects like maintaining appropriate manufacturing conditions (temperature, humidity), ensuring proper hygiene and sanitation, having qualified personnel with adequate training, keeping records accurate and complete, and performing regular equipment calibration and maintenance.5 The “5 Ps of GMP” –
People, Products, Premises, Processes, and Procedures – are fundamental tenets.5 - Good Distribution Practices (GDP): GDP is critical in maintaining pharmaceutical products’ quality, safety, and efficacy as they move through the supply chain, from manufacturing to end-users.6 GDP guidelines ensure that drugs are stored, handled, and transported under appropriate conditions to prevent contamination, damage, or any deterioration of their properties.6 This includes strict environmental control (temperature, humidity, and light), robust product traceability systems, and accurate record-keeping.6
- Serialization and Track-and-Trace: Under regulations like the DSCSA (Drug Supply Chain Security Act), all pharmaceutical products must be serialized, and detailed records must be kept tracking the product from the manufacturer to the end-user.6 This helps prevent counterfeiting and diversion.6 Technologies like RFID tags, GPS tracking devices, and temperature data loggers are often employed.2
- Cold Chain Management: A particularly complex and expensive challenge, requiring strict temperature control for sensitive medicines and vaccines. Lack of proper cold chain visibility can compromise quality compliance, leading to health risks to patients.2
- Demand-Supply Fluctuations: An ideal drug distribution system calibrates the supply according to varying patient demands, including filling last-minute demand gaps and anticipating imminent spikes in consumption.2
- Drug Theft and Counterfeiting: These are major challenges that require optimized supply chains, strict compliance norms, and robust track-and-trace systems.2
- Raw Material Management: The pharmaceutical manufacturing supply chain starts with raw materials, which are needed to ensure drug availability for patients.3 Managing raw material changes is complex due to divergent regulatory classifications across regions, leading to potential delays in implementation.3 A formal change control system under the company’s Pharmaceutical Quality System (PQS) is required to evaluate all raw material changes.3
- Rising R&D Costs: Developing a new drug now exceeds $2 billion, with lengthy development times adding significant financial strain.1
The critical role of regulatory compliance (GMP, GDP, serialization) throughout the pharma supply chain is evident. Robust compliance systems, particularly those related to track-and-trace (serialization), directly mitigate risks like counterfeiting and improve visibility to address demand-supply issues. Conversely, a failure in compliance (e.g., poor cold chain management) can lead to product spoilage and health risks, exacerbating supply chain vulnerabilities. This forms a causal loop: strong digital compliance tools lead to a more resilient supply chain, while a lack thereof amplifies existing vulnerabilities. Therefore, digital transformation in the Pharma supply chain is not just about efficiency; it is fundamentally about risk mitigation and patient safety, driven by regulatory adherence.
The Digital Transformation Imperative
Despite the clear benefits, the pharmaceutical industry faces significant hurdles in its Digital Transformation journey, often lagging behind other leading sectors.
- Fragmented Digital Landscape: The digital landscape remains fragmented, with multiple solutions, differing guidance, and inconsistent application of best practices, making it difficult for companies to determine the best path forward.8
- Legacy Systems and Data Silos: Many pharmaceutical manufacturers still rely on outdated IT and Operational Technology (OT) systems that do not communicate effectively, preventing seamless data integration and a unified, real-time view of manufacturing operations. This also raises cultural questions about system ownership and cost.8
- Scaling Challenges: One of the key concerns is how to integrate digital solutions without disrupting existing processes. A complete digital overhaul poses significant risks, particularly in an industry with strict regulatory requirements.8
- Cultural Shift and Employee Buy-in: To successfully pave the way for Digital Transformation, companies must prioritize a cultural shift that embraces innovation and adaptability. Employee buy-in is crucial, as engaged teams are the driving force behind implementing new technologies and processes.1
- Regulatory Barriers: The industry’s highly regulated nature complicates the adoption of digital tools, as they must comply with strict data integrity, patient privacy, and product safety requirements.1
The pharmaceutical industry’s lagging digital transformation, coupled with challenges like fragmented landscapes, legacy systems, and scaling issues, directly contributes to higher operational costs (e.g., in R&D and manual processes), increased risks (e.g., supply chain disruptions), and slower time-to-market. This “cost of lagging” is not merely about missed opportunities but represents an active financial drain and competitive disadvantage. Consequently, the imperative for Digital Transformation in pharma is not just about future growth, but about stemming current losses and maintaining viability in a competitive, high-cost environment.
Low-Code Automation: A Foundation for Digital Agility
In the face of the pharmaceutical industry’s complex challenges and its pressing need for Digital Transformation, low-code automation emerges as a practical and powerful solution. It offers a pathway to rapid digitalization without the extensive technical expertise or prolonged development cycles typically associated with traditional software development or complex AI implementations.
What is Low-Code Automation?
Low-code automation is a software development approach that significantly simplifies the process of building applications and automating workflows.9 It achieves this by minimizing the need for manual coding.9
- Visual, Drag-and-Drop Elements: At its core, low-code platforms utilize intuitive visual interfaces and drag-and-drop elements.9 This visual paradigm allows users to design and assemble applications graphically, much like building with digital blocks.
- Pre-built Components: These platforms come equipped with libraries of pre-built components, modules, and connectors.9 This “enterprise reuse” capability means developers can recycle existing elements instead of creating new ones for every project, enhancing consistency and reducing errors.9
- Citizen Developers: A key aspect of low-code is its ability to democratize development.9 It significantly reduces the need for extensive technical skills, empowering “citizen developers” – business users with little to no formal coding experience – to build applications that deliver business value.9 This is a significant shift, with Gartner predicting that non-developers could build
80% of technology products by 2024.9 - Distinction from No-Code: While often mentioned together, low-code differs from no-code. No-code platforms are ideal for simple, standalone applications and typically require no coding.9 Low-code, however, is designed for more complex processes, allowing for manual input and minor technical skills, combining visual interfaces with coding sections for greater customization and integration.10
Core Principles and Capabilities
The underlying principles of low-code platforms are geared towards maximizing efficiency, flexibility, and collaboration in application development.
- Faster Deployment: By reducing manual coding, low-code platforms drastically accelerate the development cycle without sacrificing quality or stability. McKinsey projected that low-code could reduce development time by as much as 90% compared to traditional coding.9 This speed allows for rapid prototyping and deployment, enabling organizations to validate concepts and gather feedback quickly.9
- Democratizing Development & Empowering Fusion Teams: Low-code fosters a cross-functional approach, enabling “fusion teams” where business users and IT professionals collaborate effectively.9 This empowers business departments, who best understand their workflows, to independently create and adjust digital solutions, reducing reliance on the central IT department.10
- Greater Agility and Flexibility: Organizations can adapt quickly and modify applications as business requirements evolve, a crucial capability in dynamic markets.9 Visual interfaces and configuration-driven development make it easier to change functionality, UI, or business logic.9
- Reusable Components and Simplified Integration: The use of reusable libraries with pre-built components, modules, and connectors, along with robust API integration capabilities 9, speeds up development and allows for seamless data exchange with existing systems, addressing challenges with fragmented data sources.9
- Effective Governance: Low-code, with proper governance, can improve security by reducing human error and “spaghetti code”.9 It also helps companies comply with changing regulations and maintain risk-proof operations, even during significant changes.10
Tangible Benefits for Pharma
For the pharmaceutical industry, these core capabilities translate into significant operational and strategic advantages.
- Cost Savings: Streamlining the development process directly improves efficiency, leading to lower development and maintenance costs. Forrester reported an impressive ROI of 598%, with $12.5 million in savings from productivity gains over three years for enterprises using Pega’s low-code platform.9 This cost-effectiveness is vital given the high R&D costs in pharma.1
- Increased Productivity and Reduced IT Complexity: By automating repetitive tasks and enabling business users to build solutions, low-code significantly increases productivity.10 It alleviates the workload on IT specialists, allowing them to focus on more complex, strategic projects.10
- Enhanced Flexibility and Compliance: The agility of low-code is particularly beneficial in strictly regulated industries like pharma, allowing for quick adaptation to new standards and data privacy laws.16 This helps maintain high-quality production standards and minimizes downtime.17
- Faster Time-to-Market: The accelerated development cycle directly contributes to a faster time-to-market for new applications and, indirectly, for new drugs by streamlining supporting processes.14
The ability of low-code to “democratize development” and empower “citizen developers” directly facilitates a crucial cultural shift within organizations. By giving non-technical employees the tools to build solutions for their own problems, it fosters a sense of ownership, innovation, and direct engagement with digital initiatives. This bottom-up empowerment can overcome resistance to change, as employees become active participants rather than passive recipients of new systems. The “new enthusiasm for digital transformation initiatives” observed in some organizations could be directly linked to this empowerment, transforming low-code into a strategic enabler for organizational culture change, which is crucial for overcoming the “digital lag” in pharma.
Furthermore, the concept of “enterprise reuse” within low-code platforms, allowing developers to recycle existing components, takes on heightened strategic importance in the highly regulated pharmaceutical industry. In an environment where consistency and error reduction are paramount (as mandated by GMP and GDP), reusing validated components means less re-validation, fewer opportunities for human error in coding, and a more standardized approach to application development. This directly supports compliance and quality assurance, making “enterprise reuse” a powerful advantage that translates directly into enhanced regulatory adherence, reduced validation burden, and improved product quality assurance within the pharmaceutical context.
Low-Code in Action: Transforming the Pharma Supply Chain
The versatility of low-code automation makes it an ideal tool for driving Digital Transformation across various critical functions within the Pharma supply chain, from early-stage research to patient delivery. Its ability to create custom applications quickly and efficiently, without extensive coding, allows pharmaceutical companies to address specific pain points and regulatory requirements.
Streamlining Research & Development (R&D)
While AI often takes the spotlight in R&D, low-code platforms can significantly enhance operational efficiency and data management in this crucial area by automating workflows.
- Clinical Trial Workflow Automation: Low-code can simplify workflows for clinical trials, including processes such as patient recruitment, consent management, and data analysis.16 This automation can help manage the complexities of trial setup and execution.
- Clinical Data Management: Automating the collection, analysis, and reporting of clinical data during drug trials is another key application.16 This ensures data integrity and helps in efficient decision-making.
- Lab Process and Documentation Automation: Biotech companies can automate workflows for laboratory processes and documentation using low-code platforms. This streamlines repetitive tasks, freeing up scientists for higher-value research activities and ensuring the consistency and standardization of lab processes, thereby reducing variability and errors.17
Enhancing Manufacturing Operations
In pharmaceutical manufacturing, where precision, quality, and compliance are non-negotiable, low-code offers robust solutions for operational improvements.
- Inventory Management: A pharmaceutical manufacturer can use a low-code/no-code platform to implement a custom inventory management application. This improves inventory tracking by enabling real-time monitoring of raw materials and finished products, reducing instances of stockouts and overstocking. Such applications can integrate seamlessly with existing Enterprise Resource Planning (ERP) and supply chain management systems for unified data management.17 Non-technical staff can easily update inventory parameters and adapt to changing production needs.17
- Quality Control and Audit Trail Applications: Low-code platforms facilitate the creation of custom dashboards and real-time reporting tools for thorough monitoring of product quality throughout the manufacturing process. Detailed traceability of all quality control activities ensures readiness for audits and regulatory inspections. The ease of updating workflows promotes continuous process improvement based on real-time data and feedback.17 For example,
Quest Nutra Pharma, operating in a heavily regulated industry, used Kissflow’s low-code platform to build and customize applications specifically for managing compliance workflows. The platform enabled teams to update regulatory processes in real-time, track quality checks, and automate compliance reporting while adhering to stringent governance requirements.12 This led to faster response times when adapting to regulatory changes, reduced risks associated with non-compliance, and positioned the company for more streamlined, risk-free operations.12 - Automating Procurement of Ingredients: Low-code automates the procurement of active pharmaceutical ingredients (APIs) and other raw materials, covering vendor management to purchase order processing.16 This streamlines a critical upstream process in the
Pharma supply chain.
Low-code’s role in regulatory compliance, quality control, and audit readiness extends beyond mere efficiency. In the pharmaceutical industry, where compliance is a foundational requirement and non-compliance carries severe penalties (including fines, recalls, and even jail time), low-code transforms from a productivity tool into a critical risk management and compliance assurance platform. By enabling rapid adaptation to changing regulations and providing robust audit trails, low-code directly addresses the challenge of regulatory complexity and divergent classifications for changes in raw materials. This makes low-code’s greatest value proposition not just cost savings or speed, but its inherent ability to build and adapt compliant systems, thereby mitigating significant regulatory and reputational risks.
Optimizing Distribution and Logistics
Efficient distribution is paramount for timely patient access and maintaining product integrity. Low-code can significantly enhance logistics operations.
- Procurement and Vendor Management: Low-code helps set up smooth procurement processes by automating purchase requisitions, supplier onboarding, contract approvals, and invoice processing.16 It facilitates smoother supply chain management by streamlining coordination with international 3PL partners and automating vendor management.16
- Supply Chain Coordination and Tracking: Custom applications can be built for inventory tracking and managing deliveries.12 This provides real-time data, dramatically reducing the strain on IT and allowing them to focus on more complex, high-priority projects.12
- Order and Delivery Management: Low-code automates order processing, from receiving orders to dispatching shipments across various online and offline channels. It can automatically calculate shipping costs, send requests to delivery services, notify customers about order status, and manage couriers.16
- Customer Self-Service Portals: Low-code enables the development of self-service portals where customers can book shipments, track deliveries in real-time, and get automated updates about order and shipment status.16 By implementing low-code automation, transportation companies can enhance efficiency, reduce operational costs, and offer a better customer experience.16
Improving Patient Engagement and Support
Beyond the core supply chain, low-code can directly impact patient outcomes and satisfaction by facilitating patient-centric solutions.
- Faster Development of Patient Solutions: Low-code platforms are transforming how pharmaceutical companies build patient-focused applications, allowing development and launch in a fraction of the time.18 This is especially helpful for creating tools like patient management apps, medication trackers, and appointment schedulers.18
- Building Scalable and Patient-Specific Solutions: Low-code tools make it easier for pharmaceutical companies to design solutions tailored to individual patient needs, offering features like personalized dashboards, automated reminders, interactive trackers, and multi-language support.18 Quick updates allow companies to adjust to patient or market changes without needing extensive technical resources or long development timelines.18
- User-Friendly Patient Portals and Apps: Low-code platforms let pharmaceutical companies design patient portals with essential features like appointment scheduling, secure messaging, and access to medical records – quickly and efficiently.18 For instance,
Snap Healthcare used low-code tools to launch a HIPAA-compliant testing and vaccination system in just 60 days. The result was a 50% boost in testing capacity and a 75% cost reduction.18 - Medication Tracking and Adherence Tools: Low-code can enable the creation of medication tracking tools with features like smart reminders, symptom tracking, progress dashboards, and educational resources to combat medication non-adherence.18 This addresses a costly issue, draining up to
$290 billion annually from the US healthcare system due to non-adherence, by making adherence more interactive and manageable.18
The emphasis on low-code’s ability to empower “citizen developers” and reduce IT backlog, as demonstrated by case studies like Puma Energy, Valantic, and CaratLane, indicates a fundamental shift in the ownership of digital solutions. Instead of IT being a bottleneck, business units such as quality control, R&D, and logistics can directly translate their deep process knowledge into functional applications. This not only speeds up development but ensures the solutions are precisely tailored to operational needs, as the users themselves are involved in the building process. This capability facilitates a decentralized approach to digital innovation, allowing domain experts within the Pharma supply chain to directly drive their own Digital Transformation initiatives, leading to more relevant and rapidly adopted solutions.
Navigating Rising Sustainability Costs: The EU CBAM and Low-Code's Role
Beyond traditional operational efficiencies, low-code automation offers a unique advantage in helping pharmaceutical companies navigate the complex and rising landscape of sustainability regulations and costs, particularly concerning the EU Carbon Border Adjustment Mechanism (CBAM). This is a critical area often overlooked by competitors, yet it has significant implications for the Pharma supply chain.
Understanding the EU Carbon Border Adjustment Mechanism (CBAM)
The EU Carbon Border Adjustment Mechanism (CBAM) is a landmark policy designed by the EU to put a fair price on carbon emissions for certain carbon-intensive goods imported into the EU.19 Its primary goal is to prevent “carbon leakage,” where companies might move carbon-intensive production outside the EU to countries with less stringent climate policies.19
- Purpose and Scope: CBAM ensures that the carbon price of imports is equivalent to that of domestic EU production, preventing the undermining of the EU’s climate objectives.19
- Transitional Phase (2023-2025): During this period, importers of covered goods must report greenhouse gas (GHG) emissions embedded in their imports (direct and indirect emissions) without needing to buy certificates.19 Companies have options for reporting methodologies, including an EU method, equivalent methods, or default reference values.19 As of January 1, 2025, a new portal allows non-EU installation operators to upload and share their emissions data with reporting declarants in a streamlined manner.19
- Definitive Regime (from 2026): From January 1, 2026, EU importers will need to register with national authorities, declare embedded emissions, and purchase CBAM certificates corresponding to those emissions. The price of these certificates will track the weekly average auction price of EU Emissions Trading System (ETS) allowances.19 If a carbon price has already been paid in the country of origin, the corresponding amount can be deducted.19
- Initial Sectors: CBAM initially applies to imports of specific carbon-intensive goods: cement, iron and steel, aluminum, fertilizers, electricity, and hydrogen.19 These sectors, when fully phased in, will eventually capture more than
50% of the emissions in ETS-covered sectors.19 - Future Scope: The product scope will be reviewed and is expected to broaden in future phases, potentially encompassing sectors like plastics, chemicals, glass, paper, ceramics, and downstream manufactured products containing carbon-intensive components.19
- Indirect Impact on the Pharmaceutical Supply Chain: While pharmaceuticals are not directly covered by CBAM’s initial scope, the regulation will have significant indirect ripple effects on the Pharma supply chain.22
- Raw Material Costs: The pharmaceutical industry relies heavily on chemicals, specialized packaging, and other raw materials.3 If these precursors or components are sourced from CBAM-covered sectors (e.g., aluminum for packaging, chemicals for synthesis, or even electricity used in their production), their cost will increase due to CBAM charges.21 This cost will likely be passed through the supply chain, impacting pharma manufacturers.
- Supplier Data Requirements: Non-EU manufacturers exporting goods into the EU (even if not directly pharma) will need to provide verified emissions data for their products.21 This pressure will cascade upstream, requiring pharma’s suppliers (e.g., chemical suppliers, packaging suppliers) to track and disclose emissions from raw material extraction through final production.21 Failure to comply with these data requests could lead to loss of market access or demand shifts, as EU customers may be forced to shift away from non-cooperative suppliers.21
- Operational Disruptions & Reputational Risks: Pharma companies could face operational disruptions if their suppliers struggle to meet new reporting or compliance obligations.22 Furthermore, companies unable to demonstrate emissions traceability and credible decarbonization strategies could face reputational damage and a competitive disadvantage within their respective industries.22
Low-Code for Sustainability and Compliance Reporting
This is where low-code automation becomes a strategic asset for the Pharma supply chain. It provides the flexibility to build custom solutions for tracking, managing, and reporting sustainability data, addressing the indirect impacts of regulations like CBAM.
- Automating ESG Data Collection: Most companies struggle with fragmented ESG (Environmental, Social, and Governance) data spread across multiple departments and systems.15 Low-code solutions can connect these disparate data sources through pre-built integrations, automating calculations for faster, more accurate reporting.15 This includes tracking Scope 1 (direct emissions from owned or controlled sources), Scope 2 (indirect emissions from purchased electricity, heat, or steam), and Scope 3 (indirect emissions from the value chain, such as supplier activities and product use) emissions.24
- Streamlining Reporting for Frameworks: Low-code platforms help organizations adapt quickly as reporting standards change.15 They can streamline data integration for frameworks like CDP, ISSB, and CSRD (Corporate Sustainability Reporting Directive).23 This ensures investment-grade, audit-ready data and helps reduce the time and cost of verification.23
- Enhancing Supply Chain Transparency and Supplier Engagement: Low-code can optimize supply chain sustainability by gathering comprehensive supplier information through intuitive questionnaires, allowing confident tracking of interactions and management of critical ESG supply chain challenges.23 This is crucial for collecting the Scope 3 emissions data that CBAM indirectly demands from upstream suppliers.21
- Customization for Specific Needs: Low-code platforms offer scalable customization for specific data reporting and collection needs.23 This means pharma companies can tailor solutions to their unique supply chain complexities and specific raw material sourcing, rather than relying on generic off-the-shelf software.23
- Real-time Monitoring and Insights: Low-code applications can provide real-time data and analytics for continuous ESG performance monitoring, helping to spot carbon hotspots and high-impact suppliers and products.23 This enables informed decision-making and aligns initiatives with business goals and targets.23
The indirect impact of CBAM on raw materials and the requirement for verified emissions data from suppliers is profound. This means pharmaceutical companies, even if not directly covered, will need to demand and process carbon footprint data from their upstream suppliers. This necessitates a digital capability to collect, standardize, and report this data. This pressure for emissions traceability acts as a powerful external driver for broader Digital Transformation within the Pharma supply chain, pushing companies to digitize supplier engagement and data management processes that might otherwise remain manual. Low-code, with its integration capabilities, is perfectly suited for this, making sustainability a core driver of digitalization.
Furthermore, the ability to demonstrate emissions traceability can transform a compliance burden into a competitive differentiator. Companies unable to demonstrate emissions traceability could face “reputational damage and a competitive disadvantage,” and EU importers may “have no choice but to shift away from non-cooperative suppliers.” This implies that proactive use of low-code to manage and report sustainability data can differentiate pharmaceutical companies and secure supply chain relationships, potentially gaining market share and enhancing their brand reputation as sustainable leaders. Low-code enables pharmaceutical companies to not only meet emerging sustainability regulations but to leverage them as a strategic advantage, securing supply chain relationships and improving market positioning.
Comparison: Traditional vs. Low-Code for ESG Data Management in Pharma
Criteria | Traditional Approach (Manual/Pro-code) | Low-Code Approach (Visual Development) |
Development Time | Months to years for custom solutions; slow for manual processes. | Weeks to months; up to 90% faster than traditional coding.9 |
Cost | High development and maintenance costs; significant human resource allocation. | Significantly lower development and maintenance costs; high ROI.9 |
Flexibility/Adaptability | Rigid, difficult to modify as standards change; requires extensive re-coding. | Highly adaptable; new metrics, calculations, and formats easily modified.15 |
Data Integration | Fragmented data across disparate systems; manual data copying prone to errors. | Connects data sources through pre-built integrations; automates data flow.15 |
User Involvement | Limited to IT specialists and developers; business users are passive. | Empowers “citizen developers” (business users) to build and refine solutions.9 |
Audit Readiness | Manual processes are prone to errors, making audits challenging and time-consuming. | Automated data collection, validation, and audit trails ensure investment-grade data.15 |
Compliance with Evolving Regulations | Slow to adapt to new or changing ESG reporting standards (e.g., CSRD, ISSB).15 | Rapid adaptation to changing reporting standards; built-in compliance tools.15 |
Complexity of Implementation | High technical complexity; requires specialized coding skills. | Simplified visual development; minimal coding expertise required.9 |
Successful Low-Code Implementation in Pharma: Best Practices
While low-code automation offers immense potential for Digital Transformation in the Pharma supply chain, successful adoption requires a strategic and structured approach. Overcoming challenges related to complex digital landscapes, legacy systems, and cultural shifts is paramount.
Strategic Adoption: Starting with High-Value Use Cases
- Targeted Pilots: It is crucial to begin with targeted, high-value use case pilots.9 Companies should choose projects where developing a customized solution would deliver significant value and build confidence with stakeholders.9 This incremental, domain-based approach allows companies to prioritize and implement digitalization in stages, ensuring a smooth transition without unnecessary operational disruptions.8
- Focus on High-Impact Areas: Prioritizing areas that yield immediate, measurable benefits, such as automating a critical quality control process or streamlining a specific R&D data flow, can demonstrate Return on Investment (ROI) quickly.8
Fostering Collaboration: Bridging IT and Business Units
- Encourage Collaboration: Leveraging the expertise of developers, business teams, and IT is crucial for the success of a low-code program.9 Low-code inherently promotes collaboration across departments by making development more intuitive.11
- Fusion Teams: Low-code enables “fusion teams” where citizen developers work alongside IT to create applications that deliver business value.9 This breaks down traditional barriers and reduces the back-and-forth in requirements development.14
- Governance to Prevent “Shadow IT”: Effective governance is essential to prevent the emergence of “shadow IT” – unauthorized systems developed outside central IT control – while still empowering business units.9
Training and Governance: Empowering Citizen Developers While Maintaining Control
- Focus on Training: While low-code simplifies development, most users will need some training to use it to its full potential.9 Comprehensive training for all users, including technical training on the new system and education about specific reporting requirements (e.g., ESG), is vital.15
- Robust Governance Frameworks: Low-code platforms enable more effective governance, improving security by reducing human error and “spaghetti code”.9 This includes defining user roles and rights 13, establishing procedures for identification, documentation, review, and approval of changes 3, and ensuring compliance with strict regulatory requirements.12
- Quality Team Integration: Having a quality team focused on improving manufacturing procedures and complying with GMP is essential.5 Low-code can help streamline and standardize workflows through a unified platform to align governance practices and enhance risk management protocols.5
Bridging Legacy Systems: Incremental Integration Strategies
- Connecting Existing Equipment: Legacy infrastructure presents a significant challenge, as outdated IT and OT systems often do not communicate effectively.8 Low-code platforms are designed to connect disparate data sources through pre-built integrations and APIs.9
- Step-by-Step Approach: Instead of a complete digital overhaul, which poses significant risks in a regulated industry, companies can adopt a step-by-step, incremental, domain-based approach.8 This allows businesses to focus on high-impact areas first, ensuring all digital projects contribute to a long-term strategy.8
- External Validation: For large pharmaceutical companies, seeking external validation of digital strategies can be invaluable. Independent feedback from experts who have experience in aligned sectors can highlight potential risks, optimize resources, and provide confidence that digital investments will deliver measurable benefits.8
The pharmaceutical industry faces significant risks with digital transformation due to legacy systems, regulatory complexity, and the need for a cultural shift. Low-code’s best practices, such as starting small, fostering collaboration, implementing strong governance, and enabling incremental integration, directly address these risks. By reducing development time and cost, empowering business users, and offering built-in compliance features, low-code allows pharmaceutical companies to experiment, validate, and scale digital solutions with lower financial and operational exposure. It mitigates the risk of large, failed IT projects common with traditional development, thereby acting as a de-risking mechanism for Digital Transformation in the highly sensitive Pharma supply chain, enabling iterative progress and higher success rates in a challenging environment.
The pharmaceutical industry stands at a pivotal moment in its Digital Transformation journey. Facing an increasingly complex global Pharma supply chain, stringent regulatory demands, and the emerging pressures of sustainability costs like the EU Carbon Border Adjustment Mechanism (CBAM), traditional approaches to software development are proving too slow, too costly, and too rigid.
Low-code automation offers a compelling and pragmatic pathway forward, proving that profound Digital Transformation can be achieved without necessarily relying on complex AI solutions. As explored, low-code platforms empower pharmaceutical companies to:
- Accelerate Development and Reduce Costs: By leveraging visual interfaces and pre-built components, low-code drastically cuts development time (up to 90% faster compared to traditional coding 9) and delivers significant cost savings (e.g.,
598% ROI for Pega users 9). - Enhance Agility and Flexibility: The ability to rapidly adapt applications to evolving business requirements and regulatory changes is paramount in the dynamic pharma landscape.9
- Democratize Innovation: Low-code empowers “citizen developers” within business units to build their own solutions, reducing IT backlogs and fostering a culture of innovation and collaboration.9
- Streamline Critical Operations: From R&D workflows and clinical data management to manufacturing inventory, quality control, procurement, and patient engagement, low-code provides tangible solutions across the entire Pharma supply chain.16
- Navigate Regulatory Complexities: It enables robust compliance management, audit readiness, and faster adaptation to evolving GMP, GDP, and serialization requirements.12
- Address Sustainability Imperatives: Crucially, low-code provides the flexibility to build custom solutions for ESG data collection, carbon footprint tracking, and compliance reporting, directly supporting responses to regulations like EU CBAM and enhancing supply chain transparency.15
While this report focuses on low-code’s capabilities “without AI,” it is important to recognize that by digitizing and standardizing processes, collecting clean data, and building a foundation of automated workflows, low-code inherently prepares pharmaceutical companies for future, more seamless AI adoption. AI thrives on structured, accessible data and well-defined processes, and low-code helps create this environment. Thus, low-code is not merely an alternative to AI; it is a potential prerequisite for effective AI implementation down the line, offering a phased and less disruptive adoption path.
Furthermore, the observation that “every company becomes a software company these days, as automation plays a significant role in a company’s ability to adapt and speed up growth” 14 is particularly relevant to the pharmaceutical sector. In an industry where custom software development has historically been slow and expensive, low-code directly enables this paradigm shift. It allows pharmaceutical companies to rapidly develop internal tools and applications tailored to their unique, highly specific needs—such as clinical trial management or specialized quality control processes. This effectively transforms them into more agile, self-sufficient “software companies” capable of continuous innovation within their complex and regulated domain, rather than solely relying on external vendors or slow internal IT processes.
The future of the Pharma supply chain is one that is agile, accessible, and sustainable. By strategically adopting low-code automation, pharmaceutical companies can not only overcome their current Digital Transformation challenges but also establish a robust, future-proof foundation for sustained growth, enhanced patient safety, and a stronger competitive edge in an increasingly demanding global market. It is time to unlock the power of low-code and build the digital future of pharma, one intuitive drag-and-drop at a time.
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For additional detail and help, please contact:
Mia Van Allen – Managing Partner – mia.vanallen@supplychainwizard.com
