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Governance, Risk, and Compliance for Life Sciences Companies: Institutionalize Compliance to Reduce Costs and Increase Productivity
Compliance is also known as :
Compliance,
Regulatory Compliance,
Easy Compliance Solutions,
Compliance & Regulation,
Compliance Mechanism,
Information about Compliance,
Supports and Educates Compliance,
Beyond Compliance Offers Compliance,
Offers Compliance Management Solutions,
Educates Compliance,
Compliance Meaning,
Compliance Definition,
Compliance Dictionary,
Access and Compliance,
Compliance Management Process,
Risk Management and Compliance,
Compliance Solutions,
Compliance Building,
Compliance Framework,
Compliance Toolkit Contains,
Looking for IT Compliance,
Quality and Compliance Management,
Review of Compliance,
IT Compliance IT Governance,
Compliance Issues,
Product Compliance Suite,
Compliance Testing Program,
Compliance Toolkit,
IT Unified Compliance Framework.
As a life sciences company, issues of
governance, risk, and compliance
(GRC) touch on nearly everything you
do. But many organizations approach
GRC in an ad hoc manner ' implementing
point solutions, one after another, in
response to regulatory demands as they
arise. This approach is inefficient and
costly. It also leads to the proliferation
of silos and a lack of transparency
concerning compliance issues.
A more effective approach is to institutionalize
GRC throughout the global enterprise.
This is where SAP® solutions
for governance, risk, and compliance
can help.
Turning GRC into a Competitive
Differentiator
SAP solutions for GRC support a holistic,
enterprise-wide approach to compliance
and risk management. While point
solutions focus on document management
and retrieval, SAP solutions for
GRC break down silos to establish a
360-degree view of compliance and
audit trail transparency. No matter what
new regulations tomorrow brings, you'll
start from a position of enterprise-wide
data visibility, process flexibility, and
role-based access to enterprise resources.
Powerful decision support
based on real-time key performance
indicators empowers personnel to manage
compliance and risk efficiently and
securely at the lowest cost. The solutions
also automate many compliance
and risk management processes,
allowing you to manage by exception.
SAP solutions for GRC rest on a solid
foundation of enterprise technologies
and applications that include the
SAP ERP application and the SAP
NetWeaver® technology platform. These
applications support industry-specific
best practices that help you streamline
compliance processes. SAP NetWeaver
provides a foundation for enterprise
service-oriented architecture (enterprise
SOA). This enables you to rapidly develop
highly flexible enterprise services
that leverage your information and
process foundation to meet specific
requirements as they emerge.
Equally important is the SAP GRC Repository
application, which documents
and stores all governance, risk, and
compliance information centrally. Its location-
specific output (required language
and data, for example) gives you
a pool of information from which to analyze
risk and make informed decisions.
The software also promotes reuse by
enabling enterprise-wide access to existing
controls to meet the demands of
new regulations.
What you get is a single platform that
helps you manage financial, operational,
environmental, and global trade compliance
and risk more effectively than previously
possible. By institutionalizing
compliance throughout the enterprise,
SAP solutions for GRC allow you to
minimize your risk while enabling innovation.
This turns compliance from an obligation
into a competitive advantage.
Financial Compliance
To comply with the Sarbanes-Oxley Act
of 2002, Basel II, and other regulations,
life science companies need appropriate
segregation of duties (SOD) and
strict access controls to safeguard
against fraud and enable sound corporate
oversight. The SAP GRC Access
Control application helps by constantly
monitoring, testing, and enforcing access
and authorization controls. Not
only does this assist corporate compliance
stakeholders in collaboratively enforcing
SOD policies, it helps you identify
and remove access and authorization
risk from IT systems, which
heightens your compliance with financial
reporting, data privacy, and current
Good Manufacturing Practice (cGMP)
mandates. With the software, you can
identify and remediate potential risks,
such as conflicting authorizations within
a single user's access profile; pinpoint
actual risks, such as business functions
that violate SOD mandates; and embed
preventive controls in business processes
to help you reduce the time,
risk, and cost associated with
compliance.
The SAP GRC Process Control application
centralizes control management
by integrating directly with control documentation
in SAP GRC Repository.
The application monitors financial-related
controls and performs autovalidation
at predefined periods. An easy-to-use
dashboard employs a global heat map
interface that helps you pinpoint control
violation risks. Detailed root cause
analysis helps you rectify problems and
continuously improve processes for
more effective corrective and preventive
actions. The software creates remediation
cases for each control
exception, immediately alerting control
owners and managers to take action. In
the end, you're able to establish controls
that promote desired employee
behavior, optimize business processes,
and ensure cost-effective compliance.
Operational Compliance
Numerous regulations in the life sciences
industry require meticulous management
of business processes. Among
them are current Good Clinical, Laboratory
and Manufacturing Practices
(cGxP) and the FDA's 21 CFR Part 11,
which sets down requirements for establishing
audit trails for electronic documents.
To combat counterfeiting,
companies must introduce electronic
pedigree controls. The SAP GRC Access
Control application ensures SOD
compliance for cGMP between different
areas of operation, for example,
production and quality management.
Powered by SAP NetWeaver, SAP solutions
for GRC ease compliance with
Part 11 requirements for documentation
and auditability, while providing a
common technical foundation that integrates
with SAP Business Suite applications
and related Part 11
functionality.
Global Trade Compliance
By embedding automated import and
export compliance into your core logistics
processes, the SAP GRC Global
Trade Services application helps you
meet the challenges posed by international,
national, and regional trade regulations.
The software automatically
screens trading partners against officially
sanctioned party lists, checks for
embargo restrictions, and manages export
and import licenses. It also provides
information that lets you take
advantage of preferential trade agreements,
such as the North American
Free Trade Agreement (NAFTA) and
those of the European Union. Ultimately,
SAP GRC Global Trade Services ensures
easy, cost-effective compliance
with all trade regulations, while reducing
cycle times, expediting customs
clearance, and mitigating financial risks
for global transactions.
Environmental Compliance
SAP and its partners provide a range of
applications to help you proactively
manage compliance related to environmental,
occupational safety, and product
safety regulations. Some of these
include:
- The SAP Environment, Health &
Safety (SAP EH&S) application '
which helps manage product and
chemical safety specifications, hazardous
substance inventories, and
dangerous goods, with functionality
for safer handling, better tracking,
and improved document management.
The software helps you perform
risk assessment, exposure logging,
incident management, exposure
profiling, and safety management for
specific work areas and supports
location-specific labeling.
- The SAP Environmental Compliance
application ' which helps you track,
analyze, and record emission data
and report to regulatory authorities.
The application, which was developed
jointly by SAP and TechniData
AG, includes functionality for automatic
emissions calculation, automatic
notification of high emissions levels,
and emissions credit determination
and documentation for emissions
trading markets.
- TechniData CfP ' which collects, organizes,
and analyzes data about
products, factories, suppliers, countries,
and customers. The application,
developed by TechniData based on
SAP NetWeaver, supports product
content and substance list documentation,
compliance checking, and automated
communication with customers
and suppliers.
Together, these EH&S applications form
a solid foundation for ensuring a
healthy work force, a clean environment,
and ongoing product safety '
while driving down the cost of
compliance.
Comply and Thrive
By providing a foundation that promotes
data transparency, process flexibility,
and controls to enforce rolebased
access, SAP solutions for GRC
help you institutionalize compliance
throughout the enterprise. You'll be
able to:
- Reduce overall compliance costs '
with a holistic, enterprise-wide approach
and industry-specific applications
that help you comply with
specific regulations at a lower cost
- Minimize risk ' with processes that
integrate compliance into the way you
do business
- Boost productivity ' with automated
compliance that enables you to focus
on core competencies
- Increase competitive advantage '
with the ability to fulfill specific regulations
faster and more effectively
than your competition
Summary
SAP® solutions for governance, risk, and compliance (GRC) help you institutionalize compliance
throughout the enterprise. With a holistic approach to GRC, you'll be able drive down
costs and reduce the occurrence of errors. This turns compliance from a regulatory obligation
into a competitive advantage.
Challenges
- Highly regulated industry constantly subjected to new requirements
- Compliance landscape made up of disconnected point solutions that are difficult and
expensive to maintain
- Low data visibility and limited audit transparency that make compliance costly and
time-consuming
Supported Business Processes and Software Functions
- Financial and operational compliance ' To establish segregation of duties and access
and process controls
- Global trade compliance ' To perform sanctioned party list screening and manage import
and export licenses
- Environmental compliance ' To support emissions management, product compliance,
and environment, health, and safety management
Business Benefi ts
- Reduce overall compliance costs ' Comply with individual regulations at a lower cost
- Minimize risk ' Integrate compliance into the way you do business
- Boost productivity ' Focus on core competencies by automating your compliance
processes
- Increase competitive advantage ' Fulfill specific regulations faster and more effectively
than your competition
For More Information
Call your SAP representative today or visit us at www.sap.com/lifesciences.