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The promises of what a digital transformation is capable of are new and exciting, but at the same time challenging and complex.
Fremont, CA: For pharmaceutical and biotech companies, the utilization of digital technologies to accelerate drug manufacturing might be challenging and complex due to the possible impact on the product quality, and ultimately patients. The industry is still searching for the best practices for its digitalization strategy and looking for a secure plan because of strict regulations and the inescapable need for ongoing GxP compliance.
Looking at the pharmaceutical and biotech industries' future, novel digital transformation technologies like artificial intelligence, deep learning, and machine learning will play an active part in their growth, success, and ability to remain competitive in the flourishing, competitive market. It is not a secret that the industry is witnessing the pressure to innovate because of an increase of personalized medicine, stricter regulations from the FDA, and competition giving rise to a need for faster time to market. Therefore, as the Pharma 4.0 shift begins to occur, GxP compliance, data integrity, and regulations need to be considered when creating a digital strategy.
The Importance of GxP compliance
Regulations and interpretations of rules are not static because there are constant updates made to the FDA's regulations to protect their priority: patient safety.
Having scientific evidence or trustworthy data readily available of your manufacturing processes will allow you to prove your operations are compliant, and medicine was produced as it was intended to overcome these hurdles.
Early Decisions Matter
Starting with a GxP compliant platform from the outset of a digital journey will help avoid the all too frequent scenario of the last 20 percent ballooning into 80 percent of the cost when GxP decisions are made of digital tools and applications. Planning and designing for the end-state of fully validated solutions from the beginning will help to budget correctly and be ready to take advantage of the learnings that will surface with better use of digital tools.
Regulators Are On Board
The industry cannot excuse any lack of digital adoption or progress with arguments based on the uncertainty around how regulators will judge their use of new tools. The FDA (Food and Drugs Administration) has incorporated cloud technology into their Emerging Technology Team, recognizing that it will influence how the FDA will assess quality systems.