The life sciences industry has faced many challenges, especially in the past five years. Organizations had to adapt and find new ways to approach managing quality and compliance process to ensure product quality and consumer safety at the face of new regulations, continuous technological advancements, intense price pressures, and a global pandemic.
Here are three key quality and compliance trends to keep in mind:
1. Connected Technology
The COVID-19 pandemic brought a new approach to conducting business for every industry. Like many companies, the life sciences industry had to adapt to a new way of working as work-from-home policies were brought into place, which led to a unique and unexpected reliance on connected technology systems and software. Quality management systems that were traditionally reliant on paper-based or hybrid processes had to quickly adapt to the digital world and the workforce had to adapt to conducting business remotely using connected technology.
This move to the digital space to conduct business led to a quick and increased adoption of cloud technologies, agile ecosystems and connected platforms to ensure smooth communication and preservation of information across departments and teams. Over three years since the beginning of the, this trend of using connected technology will only continue to grow with the possibility of work-from-home or hybrid models becoming permanent for many organizations.
2. Adopting A Data-Driven Mindset
Data management is key in life sciences quality and compliance success. Having access to data is crucial for transparency (whether it’s for audit purposes or just communicating with stakeholders) and identifying issues and/or potential future issues by establishing metrics and trends to measure risks. Employees need to be able to access and share this data in order to be able to make efficient and fast decisions in their day to day life. Consequently, the life sciences industry is moving “towards a much more rigorous use of eQMS (electronic Quality Management Systems) which can pool together data from an entire company and make it accessible to staff wherever they are.” Using these data-driven models, employees and organizations can make more reliable and informed decisions during day-to-day business and when faced with challenges.
3. Automation of Quality and Compliance
There are many repetitive and time-intensive tasks such as processing volumes of data on product quality and distribution, product labelling, and record maintenance that needs to be done by quality and compliance teams. Through the use of robotics and cognitive automation (R&CA), these teams can focus their time on other tasks.
R&CA consists of two similar technologies: robotic process automation (RPA) and robotic cognitive automation (RCA). RPA is well suited for repetitive and high-volume processes, with set steps and systems while RCA adds more complexity with its ability to process and interpret unstructured data, draw conclusions from it, and engage in predictive reasoning. R&CA is a valuable asset to increasing efficiency and is set to expand throughout the industry in the upcoming years.