workflow automation pharma

Transforming Global Drug Development Processes with Workflow Automation

The ultimate starter’s guide to streamlining critical business processes with workflow automation.

In the highly competitive and tightly regulated world of drug development, it’s crucial for organizations to find ways to improve their business processes, work smarter to stay ahead, and deliver groundbreaking solutions.

If you’re in the pharmaceuticals, biotechnology, or medical devices, you’re already aware of how precision, quality, and strict adherence to regulation compliance are vital. That’s why forward-thinking companies are turning to a technology like workflow automation to streamline their operations, boost productivity, and ensure compliance at every step of the drug development process.

Why should you care about Workflow Automation?

  1. Imagine being able to digitize and automate all your crucial business processes from end to end. Workflow automation offers just that—a comprehensive solution that helps organizations achieve operational excellence, minimize errors, and accelerate time-to-market. Automating workflows helps orchestrate tedious, manual tasks so your processes are streamlined, error-free, and efficient.
  2. One of the greatest advantages of workflow automation is its ability to bring all your systems together through integration and provide a unified view of your data. This helps you utilize data from other systems and gain complete visibility over your information and processes.
  3. From lab experiments and clinical trial management to regulatory submissions, manufacturing, and quality control, workflow automation is being used in all these areas to execute critical business processes seamlessly. This is enabling faster decision-making, improved collaboration, and ultimately, positive outcomes.

In this guide, we’re going beyond the basics and delving into the intricacies of how workflow automation can truly make a difference. We’ll explore practical applications and real-world use cases that highlight the benefits of implementing workflow automation.

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What is workflow automation and how does it work?


Workflow automation is the process of digitizing and automating business processes to improve efficiency, reduce errors, and enhance productivity. In the pharmaceutical industry, where complex and highly regulated processes are prevalent, workflow automation plays a vital role in streamlining operations and ensuring compliance.

Typically, manual activities, communication, and collaboration when done through emails, Excel sheets, and SharePoint often lack transparency at the enterprise level. Team members and leaders can see what changed after the fact but lack real-time visibility. Workflow automation works as an orchestration layer to bring people and systems together into a unified seamless process. For example, instead of sending an email to your colleague to advance a task, workflow automation notifies them automatically and assigns the task to them.

This makes it easy for everyone involved in the process to know what’s happening in the process and who is responsible for the next task at hand. This allows the teams to prioritize their work effectively using a task list that can be filtered and sorted based on priority, deadline, SLAs, and more. More importantly, it helps identify and address any process bottlenecks, avoid errors and streamline process flow.

Technology platforms like Appian provide a visual development environment (with drag-and-drop configurations) that enables both technical and non-technical users to work together to design and deploy workflow automation solutions. This visual development environment enables organizations to build applications and automate processes rapidly and with minimal coding efforts.

Appian is a leader in Low-code workflow automation and Princeton Blue’s partnership with Appian goes back 14 years. Let’s explore Appian’s workflow automation platform:

  1. Process Modeling: The first step in workflow automation is to define the sequence of activities, decision points, and rules that govern your business process. A drag-and-drop interface will allow you to visually create process models, defining the flow, stages, and dependencies of the workflow.
  2. Automation Rules: Automation rules define the logic and conditions for automating specific actions within the workflow. These rules can be based on various triggers, such as user input, system events, or data changes. With Appian, you can configure automation rules using a rule builder, defining actions to be executed automatically when certain conditions are met. The rules bring flexibility to the automation solution and avoid the need to hard-wire the business logic in the workflow.
  3. Integration Capabilities: Integration is a critical aspect of workflow automation, enabling seamless data exchange between different systems and applications. Appian provides robust integration capabilities, allowing organizations to connect with existing databases, third-party applications, and external data sources. This ensures a unified and real-time data view and facilitates smooth information flow throughout the workflow.
  4. User Interfaces: User interfaces play a crucial role in workflow automation, as they enable your end-users to interact with the system, complete tasks, and monitor progress. Appian offers customizable user interfaces, allowing you to design intuitive and user-friendly interfaces tailored to your specific needs. These interfaces can be accessed through web browsers, mobile devices, or even integrated within existing applications.

By leveraging these components, Appian’s workflow automation can easily digitize and automate your processes rapidly and effectively. This visual development approach, also commonly known as low-code process automation, minimizes the need for extensive coding and enables faster development and deployment of workflow automation solutions.

These solutions can be accessed via a browser or via a native app on iOS and Android mobile devices.

You may ask “How is workflow automation different from Robotic Process Automation (RPA) since both are automating processes?” Let’s explore the distinction between the two to gain a better understanding of their respective roles and functionalities.

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Differences between RPA and Workflow Automation

While Robotic Process Automation (RPA) and workflow automation share similarities in their goal to automate processes and improve efficiency, they are distinct concepts that serve different purposes within the realm of process automation.

Robotic Process Automation focuses on automating repetitive, and rule-based human tasks using software robots. The focus here is on rule-based tasks.

RPA software helps build “bots” that mimic human behavior for use cases that include a lot of repetition. These include working with software applications such as interacting with user interfaces, retrieving or entering data, and performing specific actions. RPA is particularly useful for automating routine tasks such as data retrieval, data entry, data validation, and report generation. Use cases like invoice processing or identifying text on a PDF, which takes up a lot of a person’s time, are activities that can be automated using RPA bots.

On the other hand, workflow automation is a broader approach that involves automating end-to-end business processes. They encompass multiple tasks, decisions, and interactions across various systems and stakeholders. These are not rule-based, and the processes are often dynamic to address different situations and often involve the judgment of an experienced human. For example, responding to an adverse event may require different approaches to solving a problem whenever there is such an event.

Workflow automation solutions, powered by Appian’s low-code platform, provide the ability to model, orchestrate, and streamline complex processes with a focus on collaboration, integration, and data flow.

The distinction between RPA and workflow automation lies in its scope and purpose.

RPA Workflow Automation
RPA targets specific tasks within a process and aims to eliminate manual intervention, reduce errors, and enhance operational efficiency. Workflow automation goes beyond task-level automation and focuses on end-to-end process optimization, ensuring seamless coordination and integration of activities across departments, systems, and stakeholders.

RPA and workflow automation are not mutually exclusive, in fact, they’re complementary approaches to process automation. RPA can be integrated into workflow automation solutions to handle repetitive tasks, while the workflow automation platform orchestrates the overall process flow, manages data exchange, and enables collaboration among stakeholders. While RPA tasks focus on routine, and repetitive tasks, humans focus on tasks that are more complex, involve judgment, require problem-solving skills, and are knowledge-driven.

In the solutions that we have built for our clients, humans and software bots work in tandem with each other. For example, if a robot fails in executing a task because of an exception that it is not trained for, the workflow automation solution involves an experienced human to deal with such an exception – this trains the bot.

In the next section, we will explore how workflow automation can be applied to streamline specific drug development processes in the pharmaceutical industry with real-world use cases and examples based on our 14 years of working with global pharmaceutical leaders in this vertical.

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Use-cases: Streamlining business processes in Pharma, Biotech, and Medical Devices

streamlining business process pharma workflow automation

Workflow automation helps greatly streamline critical business processes within the pharmaceutical industry, enabling organizations to achieve greater efficiency, collaboration, and compliance.

Let’s explore some specific drug development processes that can be streamlined through workflow automation, along with real-world use cases that highlight the benefits.

Clinical Trial Management

Clinical trial management involves a myriad of activities, including patient enrollment, data collection, monitoring, and reporting. Workflow automation can streamline these processes by automating patient recruitment, data capture and analysis, monitoring visit scheduling, and regulatory compliance tracking.

Access Management

Since clinical studies are executed at various sites across the world, a variety of systems and services need to be provisioned to users who need access to clinical study data. Traditionally, this has been a time-consuming process since each user needs to be vetted and then granted access to appropriate data sets – a process that can take months when done manually. Workflow automation automates this entire process by bringing people and systems together and greatly reduces the cycle time of this process while ensuring data security and compliance. Read this whitepaper on how we streamline access to clinical study data for our clients using workflow automation.

Regulatory Submissions

The regulatory submissions process is critical for gaining approvals for new drugs, medical devices, and therapies. Workflow automation can simplify and accelerate this process by automating the document checklist, review, and approval workflows. It can also ensure compliance with regulatory requirements and track submission timelines. As an example, a client implemented workflow automation to streamline their regulatory submissions, leading to faster submission cycles, improved document accuracy, and increased regulatory compliance.

Manufacturing Processes

Workflow automation can optimize various manufacturing processes in the pharmaceutical industry, such as batch record management, equipment calibration, inventory management, and change control. By automating these processes, organizations can reduce manual errors, improve productivity, and ensure adherence to quality standards. Workflow automation can leverage your investment into existing systems such as ERP to streamline these processes and present you with a unified view of data. For example, our client implemented workflow automation for personalized surgical planning and collaboration between the designer, manufacturer, and surgeon.

Quality Control

Quality control is crucial in ensuring the safety, efficacy, and compliance of pharmaceuticals, biotech products, and medical devices. Workflow automation can automate quality control procedures, including sample testing, documentation review, deviation management, and corrective action processes. This reduces manual effort, enhances data integrity, and facilitates real-time quality monitoring.

Clinical Supply Chain Management

Efficient supply chain management is vital for ensuring timely delivery of clinical supplies for clinical trials. . Workflow automation can streamline supply chain processes by automating order processing, inventory management, supplies scheduling, and shipment. This improves visibility, reduces lead times, and minimizes inventory carrying costs. Watch our client’s presentation on implementing workflow automation to optimize the clinical supply chain >

These are just a few examples of how workflow automation can revolutionize business processes within the pharmaceutical industry. Organizations across the sector are leveraging low-code platforms like Appian, to drive process optimization and achieve significant improvements in efficiency, compliance, and collaboration.

Here is a more comprehensive list of use cases where we implemented workflow automation solutions using the Appian Low-code Process Automation platform for our Pharmaceutical and Biotech clients.

LS Projects

In the next section, we will explore the numerous benefits of workflow automation for the pharmaceutical industry, highlighting its impact on efficiency, compliance, data integrity, and decision-making.

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What are the benefits of using Workflow Automation?

Workflow automation offers numerous benefits for the Life Sciences industry through the modernization of aging processes. Here are the key advantages of implementing it:

  1. Improved Efficiency: Workflow automation streamlines and orchestrates processes end-to-end allowing the teams to focus on what is most important at any point in time, as opposed to the traditional approach of working via emails, spreadsheets, and SharePoint. This allows people to focus on critical and complex activities, increasing overall productivity and efficiency.
  2. Reduced Errors: With automated workflows, data accuracy is enhanced, reducing the risk of mistakes, and ensuring reliable results.
  3. Accelerated Time to Market: Automation expedites processes by eliminating bottlenecks and reducing lead times. From drug discovery to clinical trials and regulatory submissions, workflow automation enables faster completion of tasks, facilitating the accelerated development and delivery of life-saving drugs and medical technologies.
  4. Enhanced Compliance: The pharmaceutical industry operates in a highly regulated environment with strict compliance requirements. Workflow automation ensures adherence to regulatory guidelines by enforcing standardized processes and documentation, reducing compliance risks, and facilitating audits and inspections.
  5. Increased Transparency: Workflow automation provides real-time visibility into workflows and processes, enabling stakeholders to monitor and track progress. This transparency enhances collaboration and communication among teams, leading to better decision-making and coordination.
  6. Collaboration: Workflow automation enables seamless collaboration between cross-functional teams, both within organizations and across outside stakeholders in the Life Sciences ecosystem. It promotes efficient information sharing, enhances teamwork, and facilitates faster decision-making, ultimately leading to improved outcomes.
  7. Data Integrity: Automating data capture and storage processes ensures data integrity and consistency. With automated workflows, data is accurately recorded, tracked, and archived, minimizing the risk of data loss or corruption. This is especially critical in areas such as clinical trials and drug safety, where data integrity is paramount as defined in the FDA’s 21 CFR regulations.
  8. Scalability: Workflow automation allows organizations in the pharmaceutical industry to scale their operations effectively. As demand increases, automated workflows can handle larger volumes of work without sacrificing quality or efficiency, enabling companies to expand their capabilities and meet growing market needs.
  9. Agility: Automation technology offers flexibility and adaptability to accommodate evolving industry requirements and ever-changing regulations. Workflows can be easily modified or updated to incorporate new processes, compliance guidelines, or best practices, ensuring organizations remain agile and responsive to the dynamic Life Sciences landscape.
  10. User Experience: Workflow Automation enables you to build modern, responsive user interfaces that work across all device forms and platforms natively out-of-the-box. This enhances the user experience of the team working on your critical business processes so they can work wherever and whenever they want.

By combining all these benefits, workflow automation significantly enhances overall productivity in the pharmaceutical industry. By automating routine tasks and optimizing processes, teams can focus on high-value activities, innovation, and strategic decision-making, driving business growth and improving patient outcomes.

In summary, workflow automation brings tremendous advantages to critical business processes in the pharmaceutical industry, including improved efficiency, reduced errors, accelerated time to market, enhanced compliance, increased transparency, collaboration, data integrity, scalability, adaptability, and overall productivity. Embracing automation can revolutionize the way your organization operates, leading to significant advancements in patient health and treatment options.

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The Next Step: Leveraging Workflow Automation

By now, you know how workflow automation can transform your processes. Its implementation brings a wide range of benefits and opportunities only limited by imagination.

To fully leverage the benefits of this technology, you should view it as a strategic imperative in your digital transformation journey. Embracing automation as a core component of your operations can unlock new opportunities and drive innovation, ultimately leading to improved patient outcomes and business growth.

In this era of rapid technological advancement, the Life Sciences industry has an unprecedented opportunity to harness the power of automation and reshape the future of healthcare. By embracing this approach, you can unlock your organization’s full potential, drive efficiency, and bring about transformative changes that positively impact the lives of millions.

At Princeton Blue, we help clients test their ideas with a proof of concept. We encourage you to utilize this to explore how Low-code Process Automation technology can address your process challenges. Let’s talk about building a proof of concept >

Watch solution demos on how we automate common use cases in the pharmaceutical industry.

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