Transcript
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
info@ivyworks.net
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
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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
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iXLc Features
Template Manager
Collaboration
Spreadsheet Workflow
Spreadsheet and Cell Level Security Based on Groups
and Workflow Stage
E-Sign & Audit Trails
Reporting
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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
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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
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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
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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
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# S503 | Manipal Centre | Dickenson Road
Bangalore – 560042 | Tel no: +91- 80- 41477219
info@ivyworks.net
Thank You!
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