Given the complex landscape of evolving regulations combined with the rapidly changing competitive marketplace, chief executives of many of today’s leading companies are faced with challenging traditional ways of conducting business to ensure a competitive supply chain, promote customer confidence and enable profitable growth.
These initiatives very often involve radical re-design of the very systems and processes that companies relied on to develop, deliver and service the products they provide. One such area where traditional programs are coming under increased scrutiny for adoption of non-traditional solutions is the area of GRC. Corporate accountability is placing increasing demands on the adoption of a GRC strategy to provide stakeholders the confidence that your business is being run in a reliable, compliant and sustainable manner.
A comprehensive Governance, Risk, & Compliance (GRC) program can save you time and money by unifying your approach to designing and implementing effective controls and risk mitigation tactics, and can provide a competitive advantage by freeing your organization to move more quickly and focus more resources on achieving business goals.
A proper risk assessment methodology, a GRC management system and strong organizational alignment are all fundamental elements of a high performance GRC program and has significant financial benefits- not just in compliance savings- but in share price improvement, legal liability avoidance and reduced cost of equity capital. Effective compliance optimization is increasingly becoming a competitive advantage because well positioned companies are more nimble, can make informed decisions when risk is quantified and can repurpose headcount from policing functions to innovation.
USDM provides industry leading solutions to the problem of GRC for life sciences companies. Our professionals work with your team to apply industry best practices to identify GRC threats and build a protective framework of policies, controls, and risk mitigation strategies.
USDM partners with Oracle Corporation and can implement Oracle’s Enterprise GRC Manager to help you automate the process of identifying risks, implementing controls and monitoring their effectiveness, and generating information that provides visibility into the overall status of your GRC strategy.
GRC Manager can help you:
- Prevent unplanned and unauthorized changes to applications
- Protect data integrity with granular user authorization, and track both successful changes and unsuccessful attempts to change data
- Monitor business transactions to detect suspicious activity, prevent fraud, and maintain compliance with policies and controls
- Remove the walls between functional silos in your organization and reduce redundant and overlapping control design and risk mitigation efforts
- Provide enterprise-wide dashboard reporting on the effectiveness of your GRC program
In addition, USDM can provide life sciences expertise to integrate FDA computer system compliance into your GRC program. Our Validation Accelerator Packs streamline the process of implementing computer systems in compliance with GxP regulations and help consolidate the overall enterprise compliance strategy when combined with GRC Manger. Validation and Part 11 compliance costs less and happens faster, and duplication of effort with other regulatory controls (e.g. SOX) are minimized.
Let us show you how the various groups in your company who are working separately on GRC initiatives can instead work together as a single, cohesive, effective team.
To learn more about USDM and how we can assist with your compliance and business objectives, please contact:
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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"Simplify, Unify and Optimize your business & compliance needs with USDM"
