What is BPM?                                              Why do we need BPM in the Life Sciences?                        ...
Identify end-to-end view of Entire Process                                                                           Ident...
Paper & Process Intensive IndustryWhy do we need BPM in the Life Sciences?         Regulations Intensive Industry         ...
BPM application should beCOMPLIANT with all applicable        Regulations                                 Do not morph the...
With BPM any information can be treated as an                                                entity (E.g. of entities - tr...
Project Lifecycle Management                                        Lab Excel Spreadsheet /                               ...
Introduction                                       Asset ManagementcBPM DEMO - Paperless                  Template Managem...
Currently, validation is a paper intensive process                with many mundane quality checks that can be            ...
Information not adequately linked                                                    to Assets or Asset Groups            ...
No way to control and enforce templates                                                       No way to enforce corporate ...
Not easy to enforce templates during authoring                                                No easy way to manage format...
Executions are paper intensive                                                 Up to 60 - 70% of executed protocol review ...
Deviation management is paper based                                                         A lot of time is spent creatin...
Discussion                                    14             ValiMation abacusBPM
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Role of Business Process Automation in FDA Regulated Industries

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

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Role of Business Process Automation in FDA Regulated Industries

  1. 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 ProcessManagement 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 1 ValiMation abacusBPM
  2. 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 programmingWhat 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 2 ValiMation abacusBPM
  3. 3. Paper & Process Intensive IndustryWhy do we need BPM in the Life Sciences? Regulations Intensive Industry High Liability Business 3 ValiMation abacusBPM
  4. 4. BPM application should beCOMPLIANT with all applicable Regulations Do not morph the business process to suit the applications 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 4 ValiMation abacusBPM
  5. 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 BusinessTechnology 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 5 ValiMation abacusBPM
  6. 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 6 ValiMation abacusBPM
  7. 7. Introduction Asset ManagementcBPM DEMO - Paperless Template ManagementValidation Document Authoring Protocol Executions Deviation Management 7 ValiMation abacusBPM
  8. 8. Currently, validation is a paper intensive process with many mundane quality checks that can be eliminated through automationIntroduction cBPM can revolutionize validation documentation authoring, management and execution. Paperless validation is a reality!!! 8 ValiMation abacusBPM
  9. 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 groupAsset 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 9 ValiMation abacusBPM
  10. 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 basisTemplate Management Creating new templates from existing templates Easy to edit, store and manage templates cBPM Enforcing corporate policies Enforcing formatting standards 10 ValiMation abacusBPM
  11. 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 Words 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 documentDocument 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 11 ValiMation abacusBPM
  12. 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 awayProtocol 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 12 ValiMation abacusBPM
  13. 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 theDeviation 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 13 ValiMation abacusBPM
  14. 14. Discussion 14 ValiMation abacusBPM

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