The Life Sciences industry is recognized as fast-paced and competitive, while adhering to the intense regulatory environment. But we see the year 2020 as a year of clarity, transformation and growth. Digital disruption will bring positive change as advances in technologies are improving business operations globally. Below are a few industry trends we believe can set the stage in this transformation and allow for the ability to embrace the power of data and disruptive digital technologies.
Identification of Medicinal Products (IDMP) regulatory changes are creating further opportunities to improve business operations and are increasing the attention on the need for sophisticated, data-driven, holistic regulatory information management (RIM) solutions. An increased focus on establishing a system that allows seamless data and content-sharing across Clinical, Regulatory, Labeling, Manufacturing and Drug Safety domains, is further driving the adoption of unified RIM solutions within the life sciences industry.
With estimated 50% of recalls due to errors in product labeling or packaging artwork, multinational pharmaceutical companies should change the way they work and ensure that improving their labeling technology is a priority. Advancing on labeling compliance and process control is a must to eliminate process inconsistencies and mitigate human errors, improving label quality and business agility to produce compliant, high-quality labels in a cost and time-efficient manner, which do not pose any risk for patient safety.
Incorporating digital quality management from the beginning avoids identified risks that deviate from standards and regulations, and proactively establishes compliant progresses through clinical development towards regulatory submission. Quality and Compliance teams must cooperate and focus on building quality and visibility into execution which can be strengthen by implementing a quality management system, covering both quality process and document management areas.
With could-based RIM implementations soaring, the on-premise deployment model is becoming a rarity also in life science industry. Flexibility, performance, global presence and optimization of operations are underlining cloud based regulatory transformation as an irreversible trend.
The automation of data extraction will be prevalent this year as more companies try to get a handle on their data to maximize its functionality. Regulatory Affairs, Drug Safety and Quality teams need the ability to extract data from fillable forms and unstructured content, then translate that data for analysis, enabling them also to surface actionable trends and indicators, which can lead to processes optimization.
Artificial Intelligence (AI) technology is entering RIM systems through the back door. Step by step, capabilities supporting content to be managed easier, processes to run more efficiently and information to be uncovered, are being implemented also with the help of AI. And the success of AI adoption in 2020 in RIM will depend on finding the right amount of everyday problems which can be solved by it.
For information about how Amplexor can help your organization keep up with the evolving changes and demands, visit our solutions page.
As Director of Products, Renato is responsible for Amplexor’s Life Sciences Product Management. He has thirteen years of experience in analyzing, designing and implementing end-to-end regulatory solutions for the Life Sciences industry. In his first nine years at Amplexor, Renato managed several implementations of integral regulatory and quality management solutions for global pharmaceutical companies as well as health authorities. Over the past four years, Renato established the Product Management organization that focuses on innovation, compliance, and quality of its product portfolio. Renato has a bachelor’s degree in Computer and Information Science from Ljubljana University.