Manage Spreadsheets in a
Regulated Environment

#59, Ground Floor, 5th Cross, Channarayappa Street, Vasanthnagar,
Bangalor...
Contents
• About ivyworks
• Why iXLc?
• iXLc Features
• iXLc Demo
• Custom Modules
• Additional Services
• System Requirem...
About ivyworks
Services for Life Sciences
• Compliance & Validation
• IT Services & IT Compliance Products
Experience & Ex...
Why iXLc?
Current Scenario
No Central Location
Procedural Controls

iXLc
Security

E-Sign & Audit Trails
Manually Lock Cel...
iXLc Features
Template
Configuration
Collaboration
Customizable
Workflow
Security
E-Sign & Audit
Trails
Email Notification...
Template Configuration
• Allows configuration of existing
spreadsheets
• Cell Level security based on Groups
and Workflow ...
Collaboration
• Central Location for latest
versions of approved
Templates & Spreadsheets
• Spreadsheet Check in /
Check o...
Customizable Workflow
• Standard 4 Stage Workflow, which can
be customized to 5 Stages (Review /
Approval)
• Configurable ...
Security
• Access based on Security
Groups in Windows Active
Directory / LDAP
• Integrated Single Sign On or
iXLc Applicat...
E-Sign & Audit Trail
• E-Sign for Review / Approval and
Saving of Spreadsheets
• Integrates with Windows Active
Directory ...
Email Notification
• Configurable Email
notifications for each
workflow stage
• Configurable Email
notifications to
Users/...
Printing
• Company Name, File Name,
File Path in the header while
printing
• Date / Time, User Name,
Page Number and Numbe...
Custom Reports
• User Friendly Graphical or
Table based Reports
• Custom Reports based on
metadata and workflow stages
• C...
Custom Modules
Stability
Management

Sample
Management

Modules
eLogBook
Confidential

Cleaning
Validation
20-Nov-13

14
Stability Management
• Custom iXLc Module to Manage Stability
Samples
• Sample Details recorded when received
(Product, St...
Sample Management
• Custom iXLc Module to Manage
Samples in Laboratories
• Sample Details recorded when
received (Sample T...
eLogBook
• Custom iXLc Module to
Manage Logbooks
(Instrument Use, Hourly
Data Entry)
• Record One Log Entry at a
time with...
Cleaning Validation
• Custom iXLc Module for Product based
Cleaning Validation using MACO/MAR
values
• Master Template con...
Additional Services
Configuration of Spreadsheet Template
Validation of Spreadsheet Template in iXLc

Migration of Spreads...
System Requirements

Confidential

20-Nov-13

20
Thank You!
#59, Ground Floor, 5th Cross, Channarayappa Street, Vasanthnagar,
Bangalore - 560052. | Tel no: +91- 80- 414772...
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Spreadsheet management tool presentation

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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

Published in: Technology
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Spreadsheet management tool presentation

  1. 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 1
  2. 2. Contents • About ivyworks • Why iXLc? • iXLc Features • iXLc Demo • Custom Modules • Additional Services • System Requirements Confidential 20-Nov-13 2
  3. 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 Confidential 20-Nov-13 3
  4. 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 20-Nov-13 4
  5. 5. iXLc Features Template Configuration Collaboration Customizable Workflow Security E-Sign & Audit Trails Email Notifications Printing Custom Reports Confidential 20-Nov-13 5
  6. 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 20-Nov-13 6
  7. 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 Confidential 20-Nov-13 7
  8. 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 Confidential 20-Nov-13 8
  9. 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 Confidential 20-Nov-13 9
  10. 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 Confidential 20-Nov-13 10
  11. 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 Confidential 20-Nov-13 11
  12. 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 Confidential 20-Nov-13 12
  13. 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 20-Nov-13 13
  14. 14. Custom Modules Stability Management Sample Management Modules eLogBook Confidential Cleaning Validation 20-Nov-13 14
  15. 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 20-Nov-13 15
  16. 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 16
  17. 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 17
  18. 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 18
  19. 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 19
  20. 20. System Requirements Confidential 20-Nov-13 20
  21. 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

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