The volume of data in modern Life Sciences continues to grow, and the way that Life Sciences firms utilize that data becomes ever broader. However, effectively managing data is no small undertaking, with most organizations having multiple systems, processes and functions, holding millions and millions of data points.
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Regulatory Information Management (RIM) is increasingly important but also hugely complex, which is why AMPLEXOR Life Sciences is such an advocate of a holistic approach to RIM. AMPLEXOR believes that companies should adopt a more modular, step-by-step methodology to next-generation RIM, an opinion shared by some of the leading experts in Life Sciences.
AMPLEXOR Life Sciences and the prioritization of holistic RIM
As one of the most influential organizations in technology, Gartner’s comments on AMPLEXOR are an honor. A report by Gartner advises Life Sciences firms to look for solutions and service vendors that make holistic RIM a strategic goal, mentioning AMPLEXOR Life Sciences as a vendor that does exactly that.
The report also recommends an IDMP data focus for Life Sciences firms wanting to transition RIM to a digital solution. This aligns perfectly with the underlying data model of the AMPLEXOR Life Sciences Suite, which is fully ISO IDMP compliant. An industry moving towards holistic RIM
The ISO IDMP database for medicinal products is expected to be fully functional in the near future, as will the new EU Medical Device Regulations. Both demand significantly more detailed insight into products and both require a holistic approach to RIM.
These industry changes demonstrate a collective realization within Life Sciences that holistic RIM has become essential. The 2018 Gens & Associates’ global Life Sciences Industry Survey 2018, revealed increased interest in a more connected, end-to-end approach to RIM.
With many companies having laid the groundwork in their RIM environment, the report suggests that they are increasingly looking for ways to build on this investment. AMPLEXOR Life Sciences has always focused on delivering solutions and services that help meet the main challenges faced by the industry. It is encouraging to see industry experts such as Gartner and Gens & Associates recognize our ability to deliver products which help Life Sciences firms on their journey to holistic RIM.
Elvis Paćelat is Vice President Compliance Management at AMPLEXOR Life Sciences.
Elvis is a business and technology executive with more than two decades of international experience in the Life Sciences market. With detailed technical understanding and expertise in compliance and regulatory content management solutions for Life Sciences, Elvis is a specialist in business impact analysis.
As AMPLEXOR’s VP Compliance Management, he is responsible for driving the corporate strategy and market success of the AMPLEXOR Life Sciences’ suite business.
Elvis is committed to delivering benefit for clients, partners and shareholders, whilst supporting client-centric strategies and spearheading groundbreaking innovations.