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More than digitizationu2019s far-reaching benefits, it has become a necessity in the pharma industry. The Food and Drug Administration (FDA) has made that quite clear through its guidelines. Companies need to eliminate the scope of human error in an industry where tolerances in precision and quality are nil. They must set up and adopt processes and SOPs to guarantee high-quality products. For more information, visit https://www.pharmision.barcodeindia.com/blogs/digital-transformation-in-pharma-manufacturing-and-its-benefits/
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Digital Transformation in Pharma Manufacturing and its Benefits
According to a KPMG study, companies in the life sciences industry have already recognized that digital transformation will lead to changing roles in the ecosystem. 85% of respondents see tech companies as the driving force of digitalization in their industry, and 63% see these companies as possible cooperation partners within the next year. More than digitization’s far-reaching benefits, it has become a necessity in the pharma industry. The Food and Drug Administration (FDA) has made that quite clear through its guidelines. Companies need to eliminate the scope of human error in an industry where tolerances in precision and quality are nil. They must set up and adopt processes and SOPs to guarantee high-quality products. Another reason why digitization is key to the life sciences industry is a certain emerging trend. The new buzzword in the pharma industry is patient-centricity. Many industry experts have the opinion that patient-centricity will be of prime importance in the coming years and digitalization is instrumental in this important step. In the same KPMG study, 17 percent of respondents named ‘patient-centricity’ as a current benefit of digitalization, while 24 percent believed this will be a key focus within the next 5 years.
But is digital transformation an absolute necessity? Let us find out… The Problem with the Traditional Way of Functioning One of the biggest challenges that pharma manufacturers with traditional setups often face are issues bridging the gaps between people and systems, people, and data, and even between groups of people. This affects manufacturing processes, performance, and even product quality. These companies’ manual processes are slow, cumbersome, and prone to human error. This negatively impacts their ability to meet the good manufacturing practice (cGMP) guidelines. The most common issues faced by these organizations include, but are not limited to Inefficient processes, Illegible and inaccurate information, data integrity, disconnected systems, and human error.
The pharma industry is known for its stringent and ever-changing regulatory checks and balances. To meet these guidelines and ever-increasing consumer demands, companies are aligning themselves with Pharma 4.0 for a greater focus on efficiency, quality, waste reduction, and cost containment. In the current scenario, where more and more companies are acknowledging the need for digitization and embracing it, any organization treading the traditional path will find it extremely challenging to keep up with their competition. Moreover, since pharmaceuticals are among the most highly regulated products, each aspect of a product’s development, testing, manufacturing, packaging, marketing, storage, distribution, and use requires a high level of scrutiny. Also, data is captured, analyzed, and reported at every stage, making the processes optimal for digitization. What a Digital Ecosystem Entails… The shift to digital is a long-term strategy that might seem daunting at first. But the benefits far outweigh the minor adjustments that are needed. Successfully transforming to a digital setup could result in significant improvements, such as more flexible production systems, faster, more collaborative development processes, higher quality, and improved monitoring of the effects of drugs. Intelligent automation is seen as the most important technological application to increase the internal efficiency of life sciences companies.
With the application of modern technology in research and clinical trials, cumbersome processes such as data analysis can be slimmed down to save costs and time. Maintaining data integrity, one of the most cited problem areas in FDA 483s, becomes much easier in a digital ecosystem, as does establishing and maintaining an audit trail. Digitization also helps in enhancing the supply chain, using the power of data and analytics, which helps to counter the rampant distribution of counterfeit medicines. To Conclude… In today’s world and soon, there will hardly be any company that has not gone digital. In the life sciences industry, it is extremely important to keep up with the latest trends and move with the times. With the pace at which technology is evolving, fast movers will have a distinct advantage over their competitors. If you belong to a company that is currently looking for options for digitization, or if you want to upgrade your existing setup, please feel free to talk to us. There are several solutions in the market today that can help you to digitize your manufacturing processes and SOPs. Investing in quality software that is compliant with 21 CFR Part 11 and ALCOA, is a must for organizations that are struggling with data integrity issues.
