This document discusses the challenges of compliance in the life sciences industry. It notes that regulatory requirements for record keeping, documentation, cybersecurity, and software validation have become more stringent in recent years. Non-compliance can result in substantial fines, legal actions, stoppage of operations, loss of licenses, and delays in product launches. Compliance officers face challenges as regulators publish more information and requirements. Many compliance leaders do not believe their current monitoring and reporting systems minimize the impact of non-compliance or provide real-time information. The document promotes a compliance training and performance platform to help life sciences organizations better manage regulatory compliance.

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
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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%
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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?
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Are you compliance ready:
47%
25%
43%
19%

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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
www.netdimensions.com/life-sciences
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
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Strategic
Remediation focused
Limited resources
Inadequate ownership
Minimal training
Compliance consulted at end of decision
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Reactive
47% Compliance leaders who agree that their
company has been proactive at implementing
regulatory changes