iXLc is a tool that is designed to efficiently manage Microsoft Excel Spreadsheets. This tool allows organizations to control and centralize the management of Excel Spreadsheets. Compliance with 21 CFR Part 11 and EU

1. Manage Spreadsheets in a
Regulated Environment
#59, Ground Floor, 5th Cross, Channarayappa Street, Vasanthnagar,
Bangalore - 560052. | Tel no: +91- 80- 41477219
info@ivyworks.net
Confidential
20-Nov-13
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2. Contents
• About ivyworks
• Why iXLc?
• iXLc Features
• iXLc Demo
• Custom Modules
• Additional Services
• System Requirements
Confidential
20-Nov-13
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3. About ivyworks
Services for Life Sciences
• Compliance & Validation
• IT Services & IT Compliance Products
Experience & Exposure
• Extensive Compliance, Validation, IT Services
& Product Experience
• Worked with Top 10 Pharmaceutical
Companies in USA, Europe & Asia
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4. Why iXLc?
Current Scenario
No Central Location
Procedural Controls
iXLc
Security
E-Sign & Audit Trails
Manually Lock Cells
No E-Sign or Audit Trail
Circulate by Email
Customizable Workflow
Collaboration
Email Notifications
Custom Reports
No Notifications or Reports
Confidential
Controlled Printing
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5. iXLc Features
Template
Configuration
Collaboration
Customizable
Workflow
Security
E-Sign & Audit
Trails
Email Notifications
Printing
Custom Reports
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6. Template Configuration
• Allows configuration of existing
spreadsheets
• Cell Level security based on Groups
and Workflow Stage (LockCells
containing formulae, calculations,
labels)
• Configure Cells to Capture User
Name and Date / Time Stamp 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.
Confidential
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7. Collaboration
• Central Location for latest
versions of approved
Templates & Spreadsheets
• Spreadsheet Check in /
Check out
• Automatic File Name
generation
• Configurable Metadata (up
to 6 parameter)
• Cell Level Commenting
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20-Nov-13
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8. Customizable Workflow
• Standard 4 Stage Workflow, which can
be customized to 5 Stages (Review /
Approval)
• Configurable State Names
• Editing and Highlighting of mandatory
/ optional cells based on Workflow
Stages
• Workflow Actions based on User
Privileges (Review /Approve / Reject)
• Ensure that all mandatory cells for a
workflow stage are completed before
proceeding to the next workflow stage
• Auto submit to next workflow stage
when all mandatory cells are
completed
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9. Security
• Access based on Security
Groups in Windows Active
Directory / LDAP
• Integrated Single Sign On or
iXLc Application Logon
• Control access to the latest
Templates and Spreadsheets
through the iXLc Application
• Prevent Local storage of
Templates & Spreadsheets
• Prevent addition or deletion
of worksheets
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10. E-Sign & Audit Trail
• E-Sign for Review / Approval and
Saving of Spreadsheets
• Integrates with Windows Active
Directory / LDAP for E-Sign
Authentication
• Audit Trails capture
modifications to spreadsheets
(old value, new value & reason
for change)
• Compliance with 21 CFR Part 11
& EU Annexure 11
• E-Sign and Audit Trail stored in
the spreadsheet itself and
cannot be modified
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11. Email Notification
• Configurable Email
notifications for each
workflow stage
• Configurable Email
notifications to
Users/Groups
• Email notification to
additional Email users
• Email notifications
using SMTP mail server
Sample Email
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12. Printing
• Company Name, File Name,
File Path in the header while
printing
• Date / Time, User Name,
Page Number and Number of
Pages in the footer while
printing
• Configurable text based on
spreadsheet state in the
footer while printing (Draft,
Reviewed, Approved)
• Product Name and Version in
the footer while printing
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13. Custom Reports
• User Friendly Graphical or
Table based Reports
• Custom Reports based on
metadata and workflow stages
• Consolidated Reports from
multiple spreadsheets based on
metadata and date range
• Advanced Search based on
metadata and date range
• Ability to drill down to
files/details
• Option to print or export to PDF
COMPANY NAME
Sample Report
Confidential
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14. Custom Modules
Stability
Management
Sample
Management
Modules
eLogBook
Confidential
Cleaning
Validation
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15. Stability Management
• Custom iXLc Module to Manage Stability
Samples
• Sample Details recorded when received
(Product, Strength, Storage Conditions,
Charged On Date, Pull Out Periods,
Expiration Date)
• Sample Details Reviewed by or Checked
by Supervisor
• Reports to display Sample Pull Out Dates
for a Particular Day, Month or Year
• Reports to display Sample Expiry Dates
for a Particular Day or Month
• Customized Reports to identify samples
based on type or storage condition
• Option to print or export to PDF
Confidential
Stability Report
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16. Sample Management
• Custom iXLc Module to Manage
Samples in Laboratories
• Sample Details recorded when
received (Sample Type,
Product, Test Parameters,
Batch Number, Sample Date,
Quantity)
• Sample Receipt Acknowledged
by various Laboratory
Departments for Testing
• Consolidated Result Entry For
Samples based on Product
• Customized Reports based on
date range, product, test
parameters, batch number
and sample type
Confidential
20-Nov-13
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17. eLogBook
• Custom iXLc Module to
Manage Logbooks
(Instrument Use, Hourly
Data Entry)
• Record One Log Entry at a
time with required details
• Automatic capture of User
Name and Date/Time of
Log Entry
• Lock all previous entries
• Review of Log Book
• View Log Book after
Review (Not Editable)
Confidential
20-Nov-13
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18. Cleaning Validation
• Custom iXLc Module for Product based
Cleaning Validation using MACO/MAR
values
• Master Template containing all Products
with details and list of equipment used
for manufacture
• Record Product Details for a new product
(Product Name, Active Ingredients,Dose,
Batch Size, Dose Limit) and select
Equipment used for manufacture
• Automatic determination of required
cleaning validation for new product based
on MACO/MAR values
• Review of results
• Automatic update of Master Template
with new Product
Confidential
20-Nov-13
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19. Additional Services
Configuration of Spreadsheet Template
Validation of Spreadsheet Template in iXLc
Migration of Spreadsheet Template
Migration of Data to iXLc
Re-Validation of validated Spreadsheet Template for use with iXLc
Custom Feature Development
Custom Report Development
Confidential
20-Nov-13
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20. System Requirements
Confidential
20-Nov-13
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21. Thank You!
#59, Ground Floor, 5th Cross, Channarayappa Street, Vasanthnagar,
Bangalore - 560052. | Tel no: +91- 80- 41477219
info@ivyworks.net
Confidential
20-Nov-13
21