Accelerating Innovation Streamlining Compliance The FDA’s Approach to Enforcement is Changing
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Accelerating Innovation
Streamlining Compliance
The FDA’s Approach to Enforcement is
Changing
Organizational Survival
is at a crossroads
• Quality Management Systems are essential to
ensuring compliance and getting safe and effective
products to market.
• Collecting product & process information is key to
establishing and maintaining market
differentiation.
• Continuous improvement & rapid learning will be
paramount to organizational survival.
Executive Management is asking . . .
Can we improve compliance with less?
Can we reduce your operational cost?
Can we maintain controls and cost?
Can we evolve quickly with changes
in the business?
Executive Responsibility
• Management with executive responsibility means
those senior employees of the manufacturer who
have the authority to establish or make changes to
the manufacturer’s quality policy and quality
systems . . .
Meeting the Challenge
Companies using manual systems
. . .
Typed Procedures (SOPs)
Ink
Signatures
Forms
Non-
Carbon
Pre -
numbered
Lists
Log books Log Sheets
Improvements with early technology
Procedures (SOPs)
Doc Mgt
User
Access
Permission
Shared
Network
Drives
Forms
Typed /
Printed Forms
Database
Word
Processor
Lists
Word Documents Spreadsheets
Recent Technology
Procedures (SOPs)
Word
Processing
Doc Mgt
e-Signature
Forms
PDFs
Databases
Web- Based
Lists
Word
Documents Spreadsheets
Custom
Coded DB
SharePoint™
Procedures (SOPs)
Word
2007
Sharepoint
Libraries
e-Signature
Forms
MS-InfoPath
Web- Based
Lists
Excel
Spreadsheets
Access
Databases
SharePoint
Lists
Improve Your Company’s Effectiveness
Integrates with lists, forms, MS
Office tools & processes to create a
cost efficient and accessible
quality system.
Change &
CAPA
Records
Procedures
& training
Process Enabling Technology
Complex Workflow
Capability
Tight Integration
with Email and MS
Office
Process Centric –
Database Platform
Scalable from a
single site
organization to an
enterprise level
system.
Designed for
collaboration and
the extended
enterprise
Microsoft®
technology – Used
in thousands of
corporations
worldwide
A Perfect Platform …
All items, activities,
changes maintain
audit trails
Complex user role-
based security,
facilitating element
level control
Highly configurable,
without
customization
Customizable alerts
for workflow, tasks,
overdue items, etc.
Native ID /
password capable
for digital
signatures & secure
records repository
21 CFR Part 11
capable architecture
The FDA’s Approach to
Enforcement is Changing
Process centric
Critical for FDA compliance
Critical for Quality operations
Critical for cost control
Business Intelligence Solutions | 1.800.782.0580 | www.busintellsol.com
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