Role of Business Process Automation in FDA Regulated Industries: What is a compliant BPM Solution?

1. What is BPM?
Why do we need BPM in the Life Sciences?
BPM application should be
Compliant Business Process COMPLIANT with all applicable
Management Regulations
The Role of Business Process
Management in FDA Regulated
Industry
How to Implement BPM
June 13, 2008 Successfully in Regulated
Industries
Presenters
Nagesh Nama -
nagesh@valimation.com
Subbu Vis -
subbu@valimation.com cBPM Implementation
Examples
ValiMation abacusBPM
cBPM DEMO - Paperless
Validation
Discussion
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2. Identify end-to-end view of Entire Process
Identify Inefficiencies
Analyze Current Scenario
Identify Bottle Necks
Identify Cost Sinks
Process Design
Evaluate Automation Options
Evaluate Workflow Options
Establish Automation Scenarios
Evaluate Costs
Evaluate ROI
Flexible Systems
Easily Deployable Systems
Use:
Easily Configurable Systems (minimum programming
What is BPM? / maximum business user friendliness)
Pre-existing Module Libraries for Rapid Deployment
Process Execution / Automation
Automation of Manual Tasks
Integration of Various Systems
To Achieve: Enhanced Visibility and Control of any Process
Optimization of Process Performance
Tracking of Metrics
Gather Metrics and Statistics
Track Time Taken and Time Sinks
Process Monitoring
Monitor and Improve Efficiencies
Enhance Process
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3. Paper & Process Intensive Industry
Why do we need BPM in the Life Sciences? Regulations Intensive Industry
High Liability Business
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4. BPM application should be
COMPLIANT with all applicable
Regulations
Do not morph the business process to suit the application's needs
Ensure the system eases the burden of the end user
Configure the application to enhance the existing business process
How to Implement BPM Ensure that business users can create basic automation / workflow with ease
- Reduce the workload on IT.
Successfully in Regulated
Industries Develop clear performance metrics for management reporting
Implement 21 CFR Part 11 compliant & validated solutions
Ensure that the BPM solution is self-regulating.... change management is built-in.
Technology Framework
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5. With BPM any information can be treated as an
entity (E.g. of entities - training record, SOP, user
profile, asset information, deviation form etc.)
Entities can be easily setup and configured using
forms, lists and libraries
Data can be centralized - Single point of entry
BPM Engine
Relationships can be established between entities
Highly configurable workflow can be
established between entities to automate
ANY business process
Data can translate to INFORMATION and KPIs!
OBA enables users to tap into the power of
enterprise applications right from desktop
applications
Enables users to focus on content rather than
format reducing document development times by
60%!
Corporate policies and quality checks can be automated
OBA - Office Business
Technology Framework
Applications Data from these documents and spreadsheets can
be turned to information
Desktop applications features and functions can
be restricted to what is necessary - reducing
clutter
Seamless integration with enterprise data
All paper data entry can be eliminated
Provide a unified dashboard. A window to all
applications to which you have access. All user
specific information and tasks are provided in one
view
Powerful search capability for fast information retrieval
Reporting capabilities. Powerful Reports can be
Portal - Collaboration
easily setup. Data from multiple sources (internal or
external) can be gathered in one common console
Collaboration features like events, notifications
and discussions can be set up by individual users
Users can subscribe to any information source
they have access to for notifications of changes
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6. Project Lifecycle Management
Lab Excel Spreadsheet /
Notebook Management
Document Management /
Knowledge Management
Validation Lifecycle
Management - Equipment,
cBPM Implementation Computer, Process, Cleaning,
Examples etc..
NDA Submissions
Batch Records Management
SOP Management / Training
Management
Change Management
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7. Introduction
Asset Management
cBPM DEMO - Paperless Template Management
Validation Document Authoring
Protocol Executions
Deviation Management
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8. Currently, validation is a paper intensive process
with many mundane quality checks that can be
eliminated through automation
Introduction cBPM can revolutionize validation
documentation authoring, management and
execution.
Paperless validation is a reality!!!
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9. Information not adequately linked
to Assets or Asset Groups
Current Scenario
No way to easily round up
validation documents related to
an asset or asset group
Asset Management
Concept of Assets & Asset Groups
Using highly configurable Workflows, Assets
cBPM / Asset Groups can be Created, Edited,
Retired, Reactivated and Linked to other
Assets, Asset Groups or Validation
Documents
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10. No way to control and enforce templates
No way to enforce corporate policies
Current Scenario during document authoring
No easy way to build content templates
on an ongoing basis
Template Management
Creating new templates from existing templates
Easy to edit, store and manage templates
cBPM
Enforcing corporate policies
Enforcing formatting standards
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11. Not easy to enforce templates during authoring
No easy way to manage formatting and styles
Authors spend 40 - 60% of time in
formatting or performing other mundane
document tasks
Current Scenario
With the great power of MS Word's features
come great responsibility! It is easy to
mess up the documents
No way to provide content examples or
guidance to develop certain sections of the
document
Document Authoring Template enforcement during document authoring
Authors focus on technical content
Instructions can be provided to authors for each section
Word features restricted to only what you need to use
Word Styles and Formats restricted to meet with
cBPM
corporate templates
Mandatory sections can be enforced
Rapid document development by using easy to
use, intuitive document authoring tools
New content template creation
from existing document
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12. Executions are paper intensive
Up to 60 - 70% of executed protocol review
time is spent performing quality checks like
Signatures, Page numbers, Crossouts,
whether all tests were completed etc.
Since executions are on paper, managing
paper executed protocols is resource
intensive
Current Scenario No information or knowledge can be
extracted from the protocols, e.g. how
many deviations, what kind of deviations,
what kind of systems provide the most
deviations, etc.
It is impossible to ensure Good Execution
Practices such as not throwing away
Protocol Executions executed protocol data sheets, or
re-executing copies, or enforcing
attachments/screenshots
Executions are paperless!!
Knowledge, information, KPIs can be obtained
throughout the validation lifecycle including
executions
All routine quality checks such as - ensuring all tests
cBPM steps are executed, all tests have passed, flagging
failed tests, ensuring all attachments are in place,
etc. can be enforced using automation
Powerful statistics reporting and navigation tools
for viewing protocol execution results are provided,
thus easing the typically arduous execution review
process
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13. Deviation management is paper based
A lot of time is spent creating, editing
and routing deviations manually
Since deviations are on paper, no
statistics or reporting can be obtained
Current Scenario No quality checks on the forms
themselves. Anyone can fill out any
section
At any given time during executions, it
is hard for anyone other than the
Deviation Management executors to get a sense of the status
of the deviations
Deviation management is paperless
A configurable electronic form is used to fill in
appropriate deviation sections
Knowledge, information, KPIs can be obtained
cBPM
throughout the validation lifecycle including
deviations
Quality checks such as - ensuring that only
certain roles can fill out certain sections of
the form can be enforced
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14. Discussion
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