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USE CASE FOR LIFE SCIENCES:
FCPA Compliance App
How can we overcome
legacy technology
that no longer meets
our needs?
GLOBAL PRESENCE
APPIAN CUSTOMER
MULTI-NATIONAL
PHARMACEUTICAL
COMPANY
CHALLENGES
Lack of transparency.
! Legacy solution being retired
exposes risk.
Antiquated technology
causing global inefficiency.
Increase transparency for
global sourcing professionals.
GOALS
Eliminate risks to company
reputation and revenue.
Create, maintain, and share
reliable and timely information
about compliance risks, globally.
GOALS
- No transparency of process or data
- Limited reporting capabilities
- Slow response time
- Inflexible capabilities
- Low user adoption
BUSINESS CASE
1. Must comply with Foreign
Corrupt Practices Act (FCPA)
2. Legacy solution in place cannot
keep pace with modern needs:
!?
APPROACH
1. Provide a platform to identify, communicate,
and mitigate risks when engaging
with healthcare providers
2. Requirements:
- Rapid creation, maintenance, and sharing of
reliable timely risk data
- Standardized business rules to avoid
inadvertent compliance risks
- Role-based access with complete audit log
for compliance
- General capabilities must include:
ease of use, mobility, collaboration,
task management, multi-language support
RESULTS
1. Increased compliance tracking when engaging foreign nationals
2. Transformed reporting, increasing scope and availability
3. Improved worker productivity
4. Expanded visibility, resulting in new metrics:
- Number of days from initial FCPA request to approval date
- Worker efficiency - amount of time to process FCPA requests
- Amount of time to generate reports
5. All covering 15 languages and spanning dozens
of countries...with Appian
Other Life Science Applications
from Appian
CLINICAL: Site Initiation – Readiness –
Effectiveness, Study Start Up, ”1572”,
IP (Green Light), Global CRO
Contracts, Pre-approval Inspection
REGULATORY: Regulatory Operations,
IDMP, e-Submissions & publishing,
On-line 510K FDA Review
CMC: High Throughput Experiment
Tracking, Global Compound Ordering, LIMS
PV: Safety Information Management,
Safety Signal Tracking
COMMERCIAL: Sales Force Automation, Contracts
HR: On-Boarding, Recruiting
IT: Asset Management. v. Resources,
Statements of Work Management
COMPLIANCE: Anti Bribery and Corruption (FCPA),
Third Party Intermediaries, Sunshine Act
Appian delivers an enterprise platform for digital transformation
that speeds time to market and value to the patient.
Powered by industry leading capabilities, Appian’s approach can
radically accelerate the time it takes to build and deploy powerful,
modern applications, on-premises or in the cloud.
The world’s most innovative life sciences organizations use
Appian to reinvent their customer experience, transform their
operations, and master regulatory compliance.
For more information, visit www.appian.com.
appian.com/pharmaappian.com/blog
Learn More

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FCPA Compliance App Increases Transparency for Global Pharma Company

  • 1. USE CASE FOR LIFE SCIENCES: FCPA Compliance App
  • 2. How can we overcome legacy technology that no longer meets our needs?
  • 4. CHALLENGES Lack of transparency. ! Legacy solution being retired exposes risk. Antiquated technology causing global inefficiency.
  • 5. Increase transparency for global sourcing professionals. GOALS Eliminate risks to company reputation and revenue. Create, maintain, and share reliable and timely information about compliance risks, globally. GOALS
  • 6. - No transparency of process or data - Limited reporting capabilities - Slow response time - Inflexible capabilities - Low user adoption BUSINESS CASE 1. Must comply with Foreign Corrupt Practices Act (FCPA) 2. Legacy solution in place cannot keep pace with modern needs: !?
  • 7. APPROACH 1. Provide a platform to identify, communicate, and mitigate risks when engaging with healthcare providers 2. Requirements: - Rapid creation, maintenance, and sharing of reliable timely risk data - Standardized business rules to avoid inadvertent compliance risks - Role-based access with complete audit log for compliance - General capabilities must include: ease of use, mobility, collaboration, task management, multi-language support
  • 8. RESULTS 1. Increased compliance tracking when engaging foreign nationals 2. Transformed reporting, increasing scope and availability 3. Improved worker productivity 4. Expanded visibility, resulting in new metrics: - Number of days from initial FCPA request to approval date - Worker efficiency - amount of time to process FCPA requests - Amount of time to generate reports 5. All covering 15 languages and spanning dozens of countries...with Appian
  • 9. Other Life Science Applications from Appian CLINICAL: Site Initiation – Readiness – Effectiveness, Study Start Up, ”1572”, IP (Green Light), Global CRO Contracts, Pre-approval Inspection REGULATORY: Regulatory Operations, IDMP, e-Submissions & publishing, On-line 510K FDA Review CMC: High Throughput Experiment Tracking, Global Compound Ordering, LIMS
  • 10. PV: Safety Information Management, Safety Signal Tracking COMMERCIAL: Sales Force Automation, Contracts HR: On-Boarding, Recruiting IT: Asset Management. v. Resources, Statements of Work Management COMPLIANCE: Anti Bribery and Corruption (FCPA), Third Party Intermediaries, Sunshine Act
  • 11. Appian delivers an enterprise platform for digital transformation that speeds time to market and value to the patient. Powered by industry leading capabilities, Appian’s approach can radically accelerate the time it takes to build and deploy powerful, modern applications, on-premises or in the cloud. The world’s most innovative life sciences organizations use Appian to reinvent their customer experience, transform their operations, and master regulatory compliance. For more information, visit www.appian.com.