This presentation presents the nuts and bolts of a Paperless Validation Platform.

1. Building a Paperless Validation
Platform Leveraging Web 2.0
Technologies
Presented By
Nagesh Nama
ValiMation abacusBPM
nagesh.nama@valimation.com
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2. Where are we today?
Living in the era of ‘dumb’ content:
• Lack of control over best practices
• No reuse of content
• Unstructured content with no context
• Compliance is expensive and not integrated into ECM and Collaboration
According to studies, the creation and maintenance of a single
page of content in regulated industries is $80 to $100 per year
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3. Current Typical Scenario
Asset Management:
• Asset information is not linked to validation entities
• Even getting the validation status of any asset is time consuming
Templates & Document Development:
• Enforcing corporate standards & best practices is very difficult
• Templates do not provide “structure” to documents. Structure turns information into
knowledge
• Templates do not enforce document format controls
• Document developers & reviewers spend a lot of time working with format instead of content.
Protocol Executions:
• Executions are completely paper based and inefficient
• Test script reviewers spend a lot of time enforcing good documentation practices
• Deviations are paper based and hence are typically a bottleneck
• Even summary report generation takes time since it is done manually
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4. Current Typical Scenario (continued)
Workflow:
• Workflow automation for complete life-cycle management is either non-existent or highly
inflexible.
• Workflow setup is too cumbersome for business users
Traceability:
• A manual chore that is extremely time consuming and costly
Collaboration:
• A collaboration workspace linked to validation life-cycle entities is non-existent
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5. Productivity Toolkit
Documents/tasks/calendars, Assets and Asset Groups
blogs, wikis, e-mail integration Approve, Revise, Retire, Reactivate
Universal doc viewer/markup Link to any validation entity
tools
Collaboration
Asset
Management
Trace any source doc Microsoft Word
to other entities Traceability Paperless Template Manager
Templates
Validation &
Enforce best
practices in Word
Documents
Workflow
Paperless
Executions
Flexible workflow feature Microsoft Word Execution Module
Seamless integration with Word Electronic deviation forms
documents
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6. Productivity Toolkit - Asset
Management
Features:
• Using Workflows, Assets - created, edited, retired, reactivated
• Assets - grouped into Groups
• Link to any other entity (eg: Specs, Reference Docs, etc..)
• Interface with Enterprise Apps to synchronize
Benefits:
• Asset database in sync with Validation Lifecycle Docs
• Data views from an asset perspective are available to determine validation status
• KPI dashboards for real-time data
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7. Productivity Toolkit - Templates and
Documents
Features:
• Template and Authoring modules - Microsoft Word plug-ins
• Documents based on schemas – providing structure
• Template Manager – smart document parts, protect document areas, embed help, menu
control, custom fields, validity checker
• Authoring Module - smart document parts, controlled access, automated reformatting
Benefits:
• Unstructured documents become structured assets
• Corporate policies and best practices are enforced
• Standardized intelligent templates lead to effective reuse of information assets
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8. Productivity Toolkit - Paperless
Executions
Features:
• Paperless Execution module - Microsoft Word plug-in
• Deviation module is e-forms
• Support for online/offline executions
• Quality checks are embedded
• Automatic summary report generation
• Real-time execution KPIs
Benefits:
• Significant reduction in execution/review time
• Increased data accuracy
• Reviewers can focus on data rather than enforcing mundane good documentation practices
• Real-time reporting
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9. Productivity Toolkit - Workflow
Features:
• Workflow features - highly configurable and flexible
• Support for e-signatures
Benefits:
• Complete lifecycle business process automation is enabled
• Workflow features can be configured and deployed by business users
• Workflow is tightly integrated with the documents
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10. Productivity Toolkit - Traceability
Features:
• Trace any source document (eg: URS) to other documents (eg: specs, test scripts, etc..)
• Tracematrix can be developed in real-time while developing the document
• Any changes in the document that impact the tracematrix are flagged
• Provides a two dimensional grid user interface for ease of use
Benefits:
• Tracematrix is automatically generated
• Tracematrix statistics are displayed in a dashboard format
• Significant reduction in Tracematrix development time
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11. Productivity Toolkit - Collaboration
Features:
• Collaborative workspaces and social computing tools - Wikis, blogs, and team discussion
boards
• Universal file viewer (browser based) for viewing, markups
Benefits:
• Empower teams to work together and collaborate more effectively
• Enable communities and connect people, teams, and expertise
• Enable ad-hoc information sharing
• Support for business process integration
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12. Summary
Paperless Validation helps organizations collaborate, eliminate
paper, increase productivity and simplify validation
Standardize Control
Develop templates that
enforce best practices
Paperless Implement validation
processes that are effective
Validation and sans paper
Comply
Increase your compliance
while reducing cost
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