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Compliance Solutions. Fortis Enterprise Document Management Westbrook Technologies Inc (August 2007). Regulatory & Compliance Landscape. Corporate Governance Sarbanes Oxley Accounting practices Transparency and ethics SEC regulations IRS, Labor, State Certification Legislation

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compliance solutions

Compliance Solutions

Fortis

Enterprise Document Management

Westbrook Technologies Inc

(August 2007)

regulatory compliance landscape
Regulatory & Compliance Landscape
  • Corporate Governance
    • Sarbanes Oxley
    • Accounting practices
    • Transparency and ethics
    • SEC regulations
  • IRS, Labor, State Certification Legislation
    • Records retention
    • Records availability and retrieval
  • Public Information and records
    • HIPAA, FERPA
    • State public records legislation
  • OSHA, EPA, FDA
    • CFR21Part11, GMP, NDA, Clean Water, Clean Air
  • Federal Reserve
    • Check 21
business challenges
Business Challenges
  • Ensure corporate policies and practices are being followed.
  • Ensure corporate governance regulations are being followed.
    • Document retention
    • Document integrity:
      • Who can view documents and when
        • Audit access/viewing of sensitive documents
      • Who can modify, alter, discard documents
        • Security over modification, versioning, deletion
        • Block overrides, workarounds
      • Records retention
        • Retention schedules
        • Destruction schedules
        • Disaster recovery
  • Impact on core business
    • Minimize impact to ongoing business processes and functions
    • Minimize cost and risk
compliance common ground
Compliance: Common Ground
  • What are the key issues – how can document management help?
  • Compliance in the bigger picture is a business practices and business ethics issue  EDM can be a very major supporting system
compliance fortis key features
Compliance: Fortis Key Features
  • Capture:
    • Capture, index all regulated documents
  • Office:
    • Put all Office document (MS Word, email) under revision control and retention
  • Versioning:
    • Track/control modification of documents
    • Maintain version histories and record of who modified
  • Security:
    • Manage access, revision, destruction rights
    • Audit trail
  • Index/retrieval:
    • Auditing, discovery, access
  • Archiving:
    • Records management, disaster recovery
fortis integrated to line of business lob systems
Fortis integrated to Line of Business (LOB) Systems
  • Fortis Office captures office documents (created and revised) systematically and manages their retention.
  • Fortis integration with ERP, CRM and SCM systems links financial documentation with financial and business transactions.
  • Fortis Approveit provides auditable approval cycles for invoices, receivables, payables, expenses.
  • Fortis ERM systematically captures and archives reports for financial and business systems.
fortis compliance benefits
Fortis: Compliance Benefits
  • Ensure document control and retention.
  • Facilitate document auditing and discovery.
  • Enforce business processes:
    • Workflows
    • Security models
    • Retention policies
  • Responsiveness to business changes:
    • Flexible security, capture, workflow models
  • Ability to audit
  • Archive security and disaster recovery capability
sarbanes oxley act penalties
Sarbanes Oxley Act - Penalties
  • Failure to maintain financial or audit workpapers (for 7 years):
    • Felony penalty: Up to 10 yrs in prison
  • Destruction or alteration of papers or records:
    • Felony penalty: Up to 20 yrs in prison
  • Securities fraud:
    • Criminal penalty: Fine and/or up to 25 yrs in prison
  • Violation of any SEC provisions:
    • Penalties increased to up to $25 million fine and 20 yrs in prison
  • State of limitations increases:
    • 2 yrs from date of discovery and 5 yrs from date fraud committed
  • Lack of auditing vigilance:
    • Audit firm can have registration suspended or revoked
    • Civil penalties
sarbanes oxley act
Sarbanes-Oxley Act
  • Internal processes
  • All audit-related documents, including working papers, must be retained for 7 years.
    • Selective retention of emails
    • All associated financial documents (paper documents, electronic documents)
  • Document management – a compliance tool:
    • Document control, security control
    • Internal controls - documentation
    • Internal controls - workflows
    • Dashboard:
      • Visibility of controlled documentation
      • Business process documentation
      • Security and access auditing

Overview

How Document Mgmt is Applied

  • Impacts Publicly Traded Firms
  • Corporate Governance
  • CEOs and CFOs personally responsible for quality of internal reporting.
hipaa
HIPAA
  • Pertains to providers and insurers
  • Requires guaranteeing privacy of patient medical and personal data
  • Accessibility of information must be strictly limited to those with a “need to know”

Overview

How Document Mgmt is Applied

  • Capture all patient records
  • Place patient records and charts within a security model
    • Secure retention
    • Control access by document type and by patient
  • Document retrieval
    • Record retention, archiving
    • Remote and indexed retrieval
    • Patient file portability with security model maintained
slide11
OSHA
  • Health testing data.
  • Plant safety 21CFR11
    • As built.
    • Mgmt of change.

Overview

How Document Mgmt is Applied

  • Place health testing data within a records management environment.
    • Secure retention.
    • Control access by document type and by patient.
    • Record retention, archiving.
    • Remote and indexed retrieval.
  • Capture plant-wide documentation.
    • Manage versioning, revision, change approvals.
    • Retrieval by plant systems and events.
slide12
FDA
  • Good manufacturing practices.
    • Manufacturing procedures.
    • Lot documentation and auditing.
    • Testing data

Overview

How Document Mgmt is Applied

  • Place lot documentation in a document management environment.
    • Capture all lot records, testing.
    • Manage by lot, by timestamp, by plant.
    • Record retention, archiving.
    • Archiving, retrieval, retention.
  • Capture plant-wide documentation.
    • Manage versioning, revision, change approvals.
    • Retrieval by plant systems and events.
nj opra example of state records management laws
NJ OPRA(Example of State Records Management Laws)
  • Open access to public information
    • Minimum access hours
    • Response time
  • Web access a preferred mechanism
  • Ensure privacy of citizen’s personal data

Overview

How Document Mgmt is Applied

  • Capture, manage, retain public records
  • Security model
    • Control access to personal information
    • Control to information types exempted from public access
  • Document retrieval
    • Web publish public document portal
    • Powerful indexing and retrieval
  • Archiving and disaster recovery
compliance fortis customer examples
Compliance: Fortis Customer Examples
  • Saucony, Inc.: Sarbanes-Oxley
    • Establish and audit internal controls.
    • Disclosure of “material events” within 48 hrs
  • Merchant Services Inc.: FTC Records retention
    • Risk, Fraud & Chargeback transaction mgmt
    • FTC records retention compliance
    • Risk and fraud investigation speed
  • HTI Inc.: OSHA Health records and documents
    • Mobile industrial health risk testing records
    • OSHA 30 year record retention compliance
    • HIPAA / OSHA privacy rules
  • Dassault Falcon Jet: FAA safety and records-keeping rules
    • Aircraft Services Engineering
    • Engineering information management and retrieval
    • FAA service and documentation requirements
fortis customers cont
Fortis Customers – cont.
  • MT Business Technologies: IRS, DOL
    • IRS required records keeping
    • DOL employee records retention
  • Union Hospital: HIPAA
    • Security and privacy complaince for HIPAA
    • Retrieval of 2.8 million medical records
  • Sotheby’s UK: Custom / export compliance
    • Proof of ownership, import/export paper trail
    • UK customs and excise compliance
  • Banner Health Hospitals: Credentialing
    • Physician credentialing and updating
    • Compliance with state licensing, DEA
  • Agfa Medical Devices: Non-conformance
    • Comply with FDA recall regulations
the fortis value proposition
The Fortis Value Proposition
  • The Fortis document management provides strong business benefits:
    • Improved work processes
    • Better and faster access to crucial business information
    • Better performance in functions such as customer service and accounts payable
    • Eliminate paper storage costs and overhead
    • Improve disaster readiness and recovery
  • At the same time as those business benefits are being realized; Fortis achieves regulatory compliance:
    • Control over document retention, modification, destruction
    • Powerful search to achieve discovery, auditing
    • Enforce workers to follow designed business processes
    • Security to ensure privacy
  • And:
    • Safeguard intellectual property
    • Guard against business espionage