Let’s just say what we’re all thinking: 2020 was rough. It threw every element of our lives into disarray. We suddenly had to become experts at navigating a new way of working, schooling and socialising. It was disruptive and it was challenging, but it was also transformative. And although the past 12 months might have felt like 12 years, it’s time to look forward to what the future holds. If 2020 was the year of disruption, 2021 will be the year of mastering change.
Pursuing innovation and breakthrough discoveries is part of the natural evolution of every industry. It’s a given that to remain competitive, companies need to adopt new technologies in order to keep up with the advances in the marketplace. The circumstances surrounding the global pandemic highlighted the need for reliable connectivity and integration, which forced many companies to move up their plans for implementing digital technologies.
COVID-19 thrust the life sciences industry into the spotlight. That said, the trends shaping quality and compliance management in 2021 will be driven by the value and necessity of connected quality.
In the full article linked below, SeerPharma's business partner MasterControl explores the following key topics:
Not long into 2020, the traditional workplace scenario began to unravel in order to abide by the social distancing mandates. Employees needed to turn basements and dining tables into makeshift offices and work remotely. Because quality management is not confined to a single department or role, companies using paper-based or hybrid quality management systems soon discovered the limitations of these systems. With a dispersed workforce, organisations lacked connectivity and continuity, making the assurance of consistent quality extremely difficult.
Whether six feet or six continents apart, colleagues need to interact, data needs to be exchanged and decisions need to be made in real time. With ongoing advancements in technology, enterprises have abundant amounts of data at their disposal. However, because data comes from a variety of sources and in different formats, companies are not able to use all the available data to its full potential.
Data analytics can be cumbersome and not always yield needed insight in a timely manner. Modernised technologies such as artificial intelligence (AI) and its associated technologies, machine learning (ML) and natural language processing (NLP), are redefining the parameters of what is possible in life sciences product development. Using historical and new data, analytical queries and ML algorithms, companies can forecast quality events, behavior and trends.
Controlling risk is an important requirement in the design, development and manufacture of health care-related products. Standards and regulations such as the International Organisation for Standardisation (ISO) 14971, International Conference on Harmonisation (ICH) Q9 and the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were instituted for the express purpose of enforcing heightened safety measures and risk management processes.
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