Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing

Build out trusted cloud infrastructures that support scalable, next-generation cloud applications. The life sciences industry is subject to numerous compliance requirements and competitive pressure which makes it paramount to ensure compliance.

Quality & Manufacturing organizations in Life Sciences companies are facing more pressure than ever to run efficient, uninterrupted production at the lowest possible cost, while meeting stringent safety, quality, and regulatory standards. Production stops can cost millions of dollars per day while consent decree fines for GMP standards violations can be exorbitant .

Challenge:

Protecting and securing patient and clinical data against external and internal threats is essential to success. Ensuring integrity, availability, and resilience of information in a logical, dynamic information architecture is a pressing challenge on biopharmas and research organizations. Establishing governance, managing risk, and demonstrating compliance are essential for pharmaceutical organizations in the changing regulatory environment.

Solution:

To help Life Sciences companies manage all of their content across the product development lifecycle, EMC® has developed the first application in a portfolio of solutions planned for the EMC Documentum® Life Sciences SolutionSuite: the Quality and Manufacturing Solution for Life Sciences.

EMC Compliance and Trust Solutions for Life Sciences enable organizations to demonstrate the compliance of their validated IT environments. We provide the tools, processes, and services to build compliant and trusted pharmaceutical cloud environments that reduce costs and improve agility.

A critical component is the ability to streamline the way companies manage their regulatory submissions and enterprise trial master file documents. EMC provides frameworks that improve the speed and flow of these communications with regulatory agencies.

This out -of- the-box, single source, enterprise-class solution ensures that Quality & Manufacturing organizations can easily and effectively control their GMP content , prevent revenue loss due to work interruptions, and eliminate compliance related fines.