Spreadsheet management tool presentation
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Transcript of Spreadsheet management tool presentation
Confidential 1 20-Nov-13
Manage Spreadsheets in a Regulated Environment
#59, Ground Floor, 5th Cross, Channarayappa Street, Vasanthnagar, Bangalore - 560052. | Tel no: +91- 80- 41477219
Confidential 2 20-Nov-13
Contents
•About ivyworks
•Why iXLc?
• iXLc Features
• iXLc Demo
•Custom Modules
•Additional Services
• System Requirements
Confidential 3 20-Nov-13
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 20-Nov-13
Why iXLc?
Current Scenario
No Central Location
Procedural Controls
Manually Lock Cells
No E-Sign or Audit Trail
Circulate by Email
No Notifications or Reports
iXLc
Security
E-Sign & Audit Trails
Customizable Workflow
Collaboration
Email Notifications
Custom Reports
Controlled Printing
Confidential 5 20-Nov-13
iXLc Features Template
Configuration
Collaboration
Customizable Workflow
Security
E-Sign & Audit Trails
Email Notifications
Printing
Custom Reports
Confidential 6 20-Nov-13
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 7 20-Nov-13
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
Confidential 8 20-Nov-13
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
Confidential 9 20-Nov-13
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
Confidential 10 20-Nov-13
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
Confidential 11 20-Nov-13
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
Confidential 12 20-Nov-13
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
Confidential 13 20-Nov-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 14 20-Nov-13
Custom Modules
Stability Management
Sample Management
eLogBook Cleaning
Validation
Modules
Confidential 15 20-Nov-13
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
Stability Report
Confidential 16 20-Nov-13
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 17 20-Nov-13
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 18 20-Nov-13
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 19 20-Nov-13
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 20-Nov-13
System Requirements
Confidential 21 20-Nov-13
#59, Ground Floor, 5th Cross, Channarayappa Street, Vasanthnagar, Bangalore - 560052. | Tel no: +91- 80- 41477219
Thank You!