Government bodies like the FDA and the EMA lay down certain regulations that the pharmaceutical industry has to adhere to. These guide pharmaceutical products to comply with the standard of quality and safety, right from the beginning to the end of their market life cycle. However, the nature of these regulations involves such complications in the follow-through processes, which are time-consuming, resource-costly, full of errors, and prone to many other issues. Organizations, in recent times, have started embracing artificial intelligence in a very friendly way to automate their compliance procedures with a lower chance of human errors. The paper will dwell on how AI influences compliance by highlighting how it is used, the benefits and limitations of AI, and what the future may hold. From reviewing related literature and a number of real-life examples in compliance, one would decipher that AI perhaps has a very cardinal role in enhancing the function, especially in record-keeping practices, risk assessment processes, and the monitoring of clinical trials. Be that as it may, besides such a boon, there are several issues: bias in AI systems, data privacy, and the complications in using new technologies. The report further lays down the guidelines as to how AI could be used for compliance-related activities so that the use of AI pushes innovation while at the same time upholding the compliance norms and safety factors.

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AI in Regulatory Compliance for Pharmaceuticals

  • Zeeshan Ahmed Mohammed,
  • Muneeruddin Mohammed,
  • Shanavaz Mohammed,
  • Mujahedullah Syed,
  • Furqan Abbas Syed

摘要

Government bodies like the FDA and the EMA lay down certain regulations that the pharmaceutical industry has to adhere to. These guide pharmaceutical products to comply with the standard of quality and safety, right from the beginning to the end of their market life cycle. However, the nature of these regulations involves such complications in the follow-through processes, which are time-consuming, resource-costly, full of errors, and prone to many other issues. Organizations, in recent times, have started embracing artificial intelligence in a very friendly way to automate their compliance procedures with a lower chance of human errors. The paper will dwell on how AI influences compliance by highlighting how it is used, the benefits and limitations of AI, and what the future may hold. From reviewing related literature and a number of real-life examples in compliance, one would decipher that AI perhaps has a very cardinal role in enhancing the function, especially in record-keeping practices, risk assessment processes, and the monitoring of clinical trials. Be that as it may, besides such a boon, there are several issues: bias in AI systems, data privacy, and the complications in using new technologies. The report further lays down the guidelines as to how AI could be used for compliance-related activities so that the use of AI pushes innovation while at the same time upholding the compliance norms and safety factors.