The fda's approach to enfocement is changing

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