Pharmaceutical manufacturing and labs are undergoing big changes around automated workflows and digitization of data. This movement towards a fully automated lab environment has sparked a change within the pharma manufacture industry—referred to as Pharma 4.0. According to the ISPE, the mission of Pharma 4.0 is “ [To] Manufacture pharmaceutical products with maximum product and process understanding, data integrity by design, efficiency and optimal resource allocation based on full digital data transparency- to the benefit of the patient”.
As laboratories’ analytical needs and demands increase, the importance of faster, more efficient processes becomes a priority. More labs are looking for ways to manage their data and better understand their processes to stay relevant in this new digital world. Pharma 4.0 seeks to address these areas by making pharma manufacturing faster, safer, and more accessible, while also focusing on the digitization of data. By doing this, the pharma manufacturing industry is moving into a new age of innovation and collaboration. Many of the organizations we work with are in the process of moving towards Pharma 4.0, and the big questions revolve around the benefits of introducing it.
Why Pharma 4.0
The idea behind Pharma 4.0 is to combine automation and digitization with increased accountability and compliance for pharmaceutical manufacturers. The ultimate goal is to create higher-quality pharmaceutical products that achieve better patient outcomes. The automation of workflows, processes, and data analysis will drastically improve the productivity of scientists by reducing manual tasks.
Another benefit of utilizing a Pharma 4.0 approach is it bridges the gap between stakeholders and industry, regulators, and healthcare by providing improved data collection and sharing across platforms and among stakeholders. This is vital in areas such as diagnostic testing, where processing and data analysis are key. By utilizing the digitization of data, multiple labs can share and access this data to move the project forward with much greater speed and efficiency.
As a lab operator, paper-based processes increase time, decrease efficiency and reduce the security of the data. Pharma 4.0 removes the need for these processes by moving to a digitized platform. This creates a safer, more intuitive way to search, categorize and analyze the data. It also provides process visibility that identifies and highlights waste or inefficiency areas, allowing engineers to create more effective training and process management for better overall performance.
As researchers can collect and manage their data better, they are discovering an increased need for a tool to help them effectively collect and manage all the information. This is where having a Laboratory Information Management System is key.
How LIMS provides Data Integrity and Efficiency
Laboratory Information Management System, or LIMS, is a software that allows labs to take their digitized data to the next level by automating workflows, sample management, and data collection. Utilizing a system such as Ovation LIMS will allow for simplification of workflows, intuitive tracking of lab activities and processes, and quick report viewing. Furthermore, utilizing the Ovation LIMS system will reduce the turnaround time between sample collection and report creation, allowing stakeholders quicker access to the information they need, when they need it. LIMS provides better compliance adherence, shorter testing times, increased productivity, and overall quality control.
Utilizing LIMS software is a key component when ensuring the quality and safety of samples and the data they provide. The LIMS will facilitate quality control within the collection and management of samples while allowing researchers to share data and results quicker. This will ultimately provide better outcomes for stakeholders and increase profitability for the companies.
As expectations for production time decrease and quality standards increase, having a system that allows you to manage all these pieces in one place is vital. Ovation LIMS provides the support to manage all these components and provides the flexibility to add or adjust workflows as needed. In this unpredictable, fast-paced world of pharma, your lab needs a system that can adapt and grow.
The Future of Pharma Operations
The continued integration of analytics and automation with product portfolios and life cycles will bring the pharma world closer to realizing the goals of Pharma 4.0. This will offer labs a competitive advantage by providing digital maturity via resources, information systems, culture, and organization, and processes. As more labs progress towards automation and digitization, they need the right tools to optimize their data. To ensure process management and better workflow efficiency, labs should establish a LIMS system that will help them optimize and move them closer to a Pharma 4.0 operating model.
As labs seek to reduce costs and improve productivity, they are also expected to maintain high scientific standards and accuracy. Moving away from paper-based systems and into the world of digital data will allow for a myriad of opportunities. Automation and real-time testing are no longer concepts but actual processes occurring in labs all over the world. As a lab operator, focusing on embracing digitization will help to reduce cost, increase compliance and provide an overall advantage. Additionally, recruiting the support of digital tools such as Ovation LIMS will help keep your data and processes organized and provide the support you need to move into the future of Pharma.
What’s Next for Your Lab
To conclude, lab operators and researchers should take steps to begin integrating the ideas of Pharma 4.0. Additionally, they must seek out assistance from a LIMS system to help their lab grow into its true potential. The future of pharma manufacturing is bright and full of exciting new technology and ideas. To capitalize on this, organizations must stay vigilant and ready to embrace the new changes coming their way. If you aren’t sure where to begin, reach out to us. We’ve worked with startup labs and seasoned labs at every stage to build a more automated laboratory.