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Life Sciences Infographic

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Learn how a centralized learning & performance management system will help you address compliance challenges in the life sciences industry.

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Life Sciences Infographic

  1. 1. Source: Cost of Compliance 2016 (Thomson Reuters, 2016). with in Life Sciences Compliance Challenges In recent years, we have seen the FDA, as well as other standards organizations, push more stringent requirements for record keeping, document control and collaboration, cyber security, software validation, and more. Substantial financial fines and legal actions Stoppage of operations and closure of inspected site Tarnished reputation that hurts the position in the marketplace Loss of license to conduct business Delay in product go-to-market plans » » » » » Consequences of Non-Compliance Challenges faced by Compliance Officers in Life Sciences in 2016 Firms expecting regulators to publish even more information in the coming years Expecting significantly more Compliance leaders in Life Sciences believe their reporting system give them a comprehensive view of compliance Agree that their reporting system provides real-time information Do not believe that current compliance monitoring and reporting systems minimize the impact of non-compliance Agree that they have access to a system with drill-down capability 26% 69% Is your LMS validated for US FDA Title 21 CFR Part 11? Are your electronic records updated in real time for proactive compliance reporting? Are you using competency-based compliance reporting to highlight current compliance levels and ongoing compliance risks? Can your LMS drill-down to specific departments, teams, and employees? » » » » Are you compliance ready: 47% 25% 43% 19%
  2. 2. Download Now Source: The challenge of compliance in Life Sciences – Moving from cost to value (Deloitte, 2015). Did you like this collateral? Then you might also be interested in our 21 CFR Part 11 Checklist NetDimensions helps organizations in the Life Sciences industry by providing a single, fully integrated training and performance platform to manage the people part of regulatory compliance. Visit our website today to learn more. From a reactive approach to compliance to a strategic approach Compliance technology enhances daily business activities Use of data analytics to identify new or emerging compliance risks Advanced training programs Compliance is at forefront of business decision » » » » Strategic Remediation focused Limited resources Inadequate ownership Minimal training Compliance consulted at end of decision » » » » » Reactive 47% Compliance leaders who agree that their company has been proactive at implementing regulatory changes