Pharmaceutical Product Development

 

Integration, Automation and Transformation

ORACLE BPM (1)

An important national pharmaceutical group decided years ago to undertake an important internal project to identify and optimize its corporate process catalogue in order to strengthen, within the organization, the process-oriented management philosophy. The result was the implementation of a process unit 100% focused on process monitoring, follow-up and continuous improvement.

What is Oracle BPM?


Oracle BPM (Business Process Management) is a software suite developed by Oracle Corporation that is used to manage and optimize business processes. This suite provides tools and functionalities that allow organizations to model, automate, measure and improve their business processes.

Data, processes, product development and people


The product development process is long (between 3 and 24 months) and under lots of regulatory process it, since they are obliged to perform (throughout the process) a multitude of physicochemical and biological tests, stability and compatibility tests, etc.

Normally, these tests take time and generate a large amount of documentation that must be collected, analysed, approved and associated with the product in question for its final submission to the Spanish Medicines Agency.

From a business point of view, the creation of a new product requires careful control of several variables: market, competition, sales expectations, pricing and costs, quality, manufacturing, logistics, etc. It is therefore essential to control each of the stages, involve the right people and have the systems and information that allow them to support each of the decisions that are made throughout the different phases.

Finally, volume comes into play. Each product enters a long cycle, complex to manage, and the environment becomes muddled when various product developments coexist in parallel, so that all the needs that are simply stated in the previous lines multiply and require a comprehensive control.

The group had identified certain fundamental requirements


Technology capable of orchestrating activities, people and tasks, as well as connecting different tools, applications and systems in general, globally and in a multi-device environment.

  • Solution that allows the easy adaptation of processes derived from market, regulatory, organizational changes, etc., and at the same time is intuitive for end users.
  • Technology capable of managing and automating from the product development process to the scaling, in the future, to the rest of the corporate processes identified in its process catalogue.
  • The tool can be easily integrated with existing corporate systems: Operational (ERP), Commercial (CRM), Analytical (BI) and Documentary (UCM).
  • Solution capable of supporting the versatility associated with complex processes and at the same time with the capacity of parameterization according to the functionalities of each process (Financial, Operational, Commercial, etc.).

Tools capable of managing the digital assets associated with each of the processes:

Even being able to manage the life cycle of the same. Allowing business users to interact and contribute their knowledge of the processes in the solution without the need for technical knowledge.

Oracle_BPM

Tool with analytical and monitoring capabilities:

To control and identify inefficiencies
and/or bottlenecks associated to the product development process and in the future to the rest of the corporate processes
that will be incorporated to the solution.

Solution Implemented


 

After analysing several of the existing solutions on the market, we finally recommended the client to opt for a BPM software solution. BPM software solution software solution that covered all the requirements identified and also provided great advantages in the following areas:

  1. Product Maturity

  2. Manufacturer Dimension

  3. Functionality vs. Cost Ratio

Based on the functionality of the chosen solution and after interacting with all the departments related to the process of Pharmaceutical Product Development, we launched the construction project divided into 3 phases:

  • Construction of Project Management functionality within the Solution, which allows the pharmaceutical group to track the entire catalog of product development projects in progress, something that until now required a lot of time and dedication from those in charge. Now they analyze deviations and make decisions more efficiently and quickly, and manage their PORTFOLIO globally from a single place and with unique and reliable information.
  • Implementation of a BPM Solution (Business Process Management)The implementation of a BPM (Business Process Management) Solution, taking into account the activities and tasks, the people responsible, the different variants and casuistry that the process may go through during its life cycle, the documentation that is produced and the notifications and approvals required for each phase, through the modeling and standardization of the process.
  • Integration Services of the proposed solution with your internal systems, whose result is extremely beneficial, since at the end of a Product Development Process it automatically generates a "Medical-Pharmaceutical Dossier" of great relevance for the Spanish Agency of Medicines and its subsequent commercialization.

Conclusions

A few months into the project, the group now manages all its product development projects within the solution. Having achieved complete visibility of their portfolio, they can now not only anticipate the needs of each of their developments, but also adjust the timing of their process to the needs of the market and their sales force.

Grafico 2 BPM.png

Your teams of Project Managers can control their project roadmap, act proactively on each task, on each responsible and make or escalate strategic decisions with sufficient reaction time to avoid jeopardizing the achievement of objectives. The process of gathering, preparing and consolidating all the documentation related to a new pharmaceutical product has been dramatically simplified
achieving very high cost savings, increasing the success rate in internal audits and drastically eliminating the incidences related to the documentary dossier generated for the Spanish drug agency.

The success of this implementation has accelerated the Group to start implementing other corporate processes within the solution related to areas as diverse as HR, Sales and Legal.

 

Article writed for Farmaespaña Industrial magazine


Oracle BPM (Business Process Management) and Oracle Integration Cloud are two related products that can work together to help organizations manage their business processes and achieve more efficient integration of their applications and systems. Here's how these two products are related:

  1. Process and application integration: Oracle BPM is used to model, automate and optimize business processes. It allows defining workflows and business rules to manage end-to-end processes in an organization. On the other hand, Oracle Integration Cloud focuses on the integration of applications and systems, enabling connectivity between local and cloud applications, as well as data transformation and service orchestration.

  2. Process and workflow automation: Oracle BPM focuses on business process automation, which means it can manage workflow execution, task assignment, tracking and monitoring of business processes. Oracle Integration Cloud, on the other hand, is used to integrate applications and systems, including data transformation and orchestration of services to facilitate communication between applications.

  3. Collaboration: Both Oracle BPM and Oracle Integration Cloud enable collaboration between teams and stakeholders. Oracle BPM facilitates collaboration in the design and execution of business processes, while Oracle Integration Cloud promotes collaboration in the integration of applications and systems.

  4. Together for complete solutions: In many cases, organizations use Oracle BPM and Oracle Integration Cloud together to address broader business needs. For example, they can use Oracle BPM to manage and automate complex business processes while using Oracle Integration Cloud to effectively integrate applications and systems into those processes. This enables the creation of complete solutions that span from process definition to execution and integration with existing systems.

In summary, Oracle BPM and Oracle Integration Cloud are two complementary products that can work together to help organizations improve business process management and application and system integration. Together, they provide a complete solution to address process automation and optimization needs, as well as application integration in the enterprise environment.

 

Oracle Named a Leader for Five Consecutive Years in Gartner® Magic Quadrant™ for Enterprise Integration Platform as a Service

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Why Neteris


At Neteris we recommend CLOUD Process Management, as it is the best way for us to enable change and move forward, faster, by creating more flexible, intuitive and data-driven organizations that use their processes as a true lever for improvement and optimization.

In addition, Neteris is a certified company and appointed as a Digitalizing Agent as part of the Digital Kit initiative of the Government of Spain, with which we can help in the digital maturation process of your company.

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