- Alessandra Sist , Senior Consultant, Manufacturing & Supply Chain, NNIT.
Implementing a monolithic MES is not the only option for digital transformation in life sciences. By combining a low-code platform like Tulip with a standardized approach to validation, you can build many of the apps you need with relative ease.
While most life sciences companies recognize the potential of digitalization, the time and effort required to implement and validate a standard Manufacturing Execution System (MES) is a major challenge. MES systems are typically provided as monolithic systems and the many benefits of implementing an MES system are often not realized due to fear of the validation effort and the associated costs and specialized resources required.
After completion of the design phase of an MES implementation, you need to validate all functionalities and processes. This crucial step constitutes a significant portion of the project. Validation is required to ensure that the system meets the regulatory compliance standards and is ready for release to the final users.
Due to the length and complexity of a MES implementation, processes designed months before may have changed once the system is ready for release. This can mean significant rework, additional costs, and delays. To stay competitive, you may need a more agile and responsive way to digitalize your processes.
Tulip: the low-code alternative to monolithic systems
A low-code platform like Tulip can be an effective supplement or alternative to the MES and other monolithic systems. It allows you to prioritize your core needs and rapidly deploy small applications to address specific business processes.
One of the major benefits of Tulip is that the platform is already qualified by the vendor. In general, the Tulip low-code applications can be developed and qualified with relative ease and exploiting the current industry best practices following the three-step process illustrated in the following diagram:
Step 1: Leverage a GMP-qualified platform
The Tulip Quality Management System is certified ISO 9001:2015. This means that the Tulip platform is "GMP ready" as it was developed using a Software Development Lifecycle (SDLC) based on GAMP guidelines and Agile standards. All the qualification documents are available online for easy inspection and fast retrieval.
Step 2: Develop low-code apps
Because the Tulip platform is already validated, you can easily develop low code applications to match specific business need. For example, you could replace paper-based batch records with a digital Electronic Batch Records (EBR) system, create digital work instructions for manufacturing and lab processes or track employee training through a custom app. Use agile development methodologies to maintain focus on the content and ensure quality by design.
Step 3: Validate the apps
To release a low-code application to production, you simply need to validate the intended use of the specific application. To streamline the validation process, implement a standard approach according to a risk-based strategy and the principles of Computer Software Assurance (CSA) to ensure that the software performs as intended.
Benefits of the low-code approach
Low-code platforms enable you to the gradually implement and validate digitalized processes in a streamlined and compliant way. By doing so, they facilitate a seamless transition to industry digital transformation.
By adopting platforms like Tulip, you can build custom solutions, prioritize specific needs, and get applications from idea to production faster.
Some of the benefits of using the Tulip platform include:
- Reduced need for specialized validation resources. Once the standard approach for app validation in internal procedures is defined, you can rely on internal resources for managing routine work, as less effort is required compared to a standard MES implementation.
- Rapid delivery to end users. Creating low-code applications in a step-by-step manner allows you to deliver small, quick solutions to specific business needs. Each low-code application can be built, validated, and released to users in a short timeframe.
- Controlled management of the app life cycle. The Tulip platform offers the capability to create built-in compliance, controlling changes to the applications and enabling automated regression testing.
What NNIT brings to the table:
- More than 5 years hands-on experience of applying low-code solutions in the life sciences industry - in GxP as well as non-GxP environments.
- A resulting library of best-practice process apps.
- An outstanding process expertise stretching across all process domains from API & Biotech, Cell & Gene, Secondary manufacturing & packaging as well as medical device.
- A deep understanding of all steps in the life cycle management of a drug product from R&D through the clinical phases to upscale & commercial manufacturing and the digitalization challenges hidden in each of them.
- A strong track history of successful projects on vertical and horizontal integration of processes including all the typical underlying system platforms (MES, LIMS, ERP, QMS, Logistics & supply chain solutions, Data Analytics platforms, Track & Trace).
- A fast-track targeted approach to the adoption of low-code solutions from the initial idea through agile implementation, system & app validation to training, go-live and continuous improvement.
