In pursuit of software solutions for pharmaceutical regulatory affairs: Insights and trends.

With rapid upsurge in technology and digital tools, the existing systems including the healthcare systems, especially the pharmaceutical sector is experiencing the revolution in the flow and management of data. Use of digital tools in pharmaceutical regulatory framework and compliance has led to development of a more harmonized system globally. This has facilitated growth in pharmaceutical sector internationally along with timely availability of healthcare facilities with assured safety and efficacy. Technological solutions have upgraded the workflow in industry with the assurance of data veracity. Clinical studies demand for a huge controlled study design and data which concerns patient safety; it includes statistical interpretations and analysis. This is mostly time dependent variable and smart use of software and tools accelerate this process. Automation of the work reduces time, efforts and also streamlines timely submissions. Advanced technologies with support of machine learning, artificial intelligence would assist industry and regulatory authorities to build transparency between the documentation and data. Many regulatory agencies have come up with regulations for validation of electronic tools and data integrity to ensure ethical use of these tools. US Federal law, 21CFR is recognized and have been widely accepted. However, most of the countries have their own regulatory agency that governs these regulations. Artificial Intelligence have come up with add-on features which would overcome the lag in the systems and simplify the operations and interpretations of various studies in pharmaceutical sector. Yet, with the advancing technologies there is need for more precise regulations to evaluate it through all parameters.