iXLC

Confidential 1 22-Feb-12

Security Risk Management Compliance Delivered to manage spreadsheets in a regulated environment

# S503 | Manipal Centre | Dickenson Road

Bangalore – 560042 | Tel no: +91- 80- 41477219

[email protected]

Confidential 2 22-Feb-12

Contents

• About ivyworks

• Business Challenges

• iXLC Features

• Additional Features

• System Requirements

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About ivyworks

•Compliance & Validation

• IT Services & IT Compliance Products

Services for Life Sciences

•Extensive Compliance, Validation, IT Services & Product Experience

•Worked with Top 10 Pharmaceutical Companies in USA, Europe & Asia

Experience & Exposure

Confidential 4 22-Feb-12

Business Challenges

•Availability of the latest version of spreadsheet template & spreadsheets in central locations

•Prevention of local storage of spreadsheet templates

•Check in / Check out of spreadsheets (version control)

•Notifications (Email)

Collaboration

•Workflows for review / approval

•E-Signs, Audit Trails that comply with relevant guidelines like 21 CFR Part 11 and EU Annexure 11

Workflow

E-Sign

Audit Trails

•Access to spreadsheets limited to authorized users based on groups and status

•Ability to edit cells within the spreadsheet based on status

•Inclusion of default / configured information while printing (Date/ Time, User Name, Status, etc.)

Security

Confidential 5 22-Feb-12

iXLc Features

Template Manager

Collaboration

Spreadsheet Workflow

Spreadsheet and Cell Level Security Based on Groups

and Workflow Stage

E-Sign & Audit Trails

Reporting

Confidential 6 22-Feb-12

Template Manager

• Allows configuration of existing

spreadsheets

• Cell Level security based on Groups and

Workflow Stage (Lock Cells containing

formulae, calculations, labels)

• Capture User Name and Date/Time

Stamp in Cells at each Workflow Stage

• Configure Cells as Mandatory or Optional

for Data Entry based on Workflow Stage

• Allows the use of inbuilt Excel features

like data validation, Cell Formatting,

Decimals, Data Types, etc.

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Template Manager - Screenshot

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Collaboration

• Central Location for Approved

Spreadsheet Templates & Spreadsheets

• Access only through iXLc application

ensuring use of latest spreadsheet

templates & spreadsheets

• No Local storage of Spreadsheet

Templates & Spreadsheets

• Spreadsheet Check in / Check out

• Auto Unique File Name and Additional

Spreadsheet metadata (Project and

Title) for easy access

• Configurable Email notifications to

Groups

Confidential 9 22-Feb-12

Spreadsheet Workflow & Security

• Access to Authorized Users based on

Windows Authentication & AD Groups

• Configurable Review / Approval

Workflows

• Restrict Access to Spreadsheets based on

Groups & Workflow Stage (i.e. Analysts

for data entry, Department Heads for

Review, QA for Approval, etc…)

• Highlight and Allow Editing of cells

marked as mandatory / optional based

on Workflow Stage

• Reviewer / Approver can Review /

Approve or Reject

Confidential 10 22-Feb-12

E-Sign & Audit Trail

• E-Sign for Review / Approval and Saving

of Spreadsheets

• Integrates with Windows Active

Directory for E-Sign Authentication

• Audit Trails capture modifications to

spreadsheets

• Compliance with 21 CFR Part 11 & EU

Annexure 11

• E-Sign and Audit Trail stored in the

spreadsheet itself

Confidential 11 22-Feb-12

E-Sign Screenshot

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Audit Trail Screenshot

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Reporting

• View Report for spreadsheets based

Workflow Stage & Projects

• Advanced Search to limit based on a

time frame

• Pie Chart Reports

• Drill down to see files for a report

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Reporting - Screenshot

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Why iXLc?

Current Scenario

No Central Location

Procedural Controls

Manually Lock Cells

iXLc

Spreadsheet & Cell Level Security

E-Sign & Audit Trails

Workflow

Collaboration

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Additional Services

Template Development

Customization

Configuration Validation

iXLc

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System Requirements Serv

er Windows Server 2003

SP2 or 2008 or R2

Windows Installer 3.1

Microsoft .NET Framework 4 Client Profile

Client Windows XP SP3 or

Windows 7

Microsoft Excel 2007 or higher

Windows Installer 3.1

Microsoft .NET Framework 4 Client Profile

Microsoft Visual Studio 2010 Tools for Office or Microsoft Visual Studio 2008 Tools for Office or VSTO runtime 4.0

Confidential 18 22-Feb-12

# S503 | Manipal Centre | Dickenson Road

Bangalore – 560042 | Tel no: +91- 80- 41477219

[email protected]

Thank You!