1. #SummitNow Controlled Documents Solution for Life Sciences November 13th Craig Burnett - Hospira Dave Giordano – Technology Services Group

2. #SummitNow Who is Hospira? Global Pharmaceutical Drug and Device Manufacturer Formerly Abbott Hospital Product Division (HPD) Headquartered in the US, operates in over 70 countries worldwide

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4. Document Control - Types of Documents Standard Operating Procedures Policies Procedures Test Methods Specifications Design Documents Validation Documents Special Studies Others…

5. #SummitNow Compliance is all about….. Managing change in a controlled fashion…. Making sure that right people are seeing the right document at the right time…… Improving the communications of processes and procedures that are clearly written and can be followed without error…… And ensuring that they are not seeing the wrong document – resulting in out of compliance

6. #SummitNow Why are viewing the wrong documents such an issue? If a product is made, and the wrong SOP is followed, it could have bad results….

7. #SummitNow What are the wrong documents? Unapproved – Unreleased – DRAFT - Superseded Printed last week Word version that could be changed…

8. #SummitNow Ensuring right document With the new solution, we can ensure: - Consumers only see Approved-Major Versions; not DRAFT - Authors can only create DRAFT - Content is Approved via System Controlled Workflow - Consumers only see PDF with Watermarks on Approved Copies

9. #SummitNow Major and Minor Versions 0.10.2 Minor Version … Major Version 1.0 1.11.2 Minor Version tsg:supersedes Draft Approved Draft Major Version 2.0 Approved Draft … Approval

10. #SummitNow Versioning and Workflow Approval

11. #SummitNow Security StateInitiatorsDoc ControlApproversConsumers DraftWrite ReadNone ApprovedReadWriteReadRead or None EffectiveReadWriteRead SupersededRead None ObsoleteRead None

12. #SummitNow Document Viewing Most clients are PDF based Turn source document into PDF It is important to ensure printed document is the latest Many “overlay” information on document Document Status, Effectivity and Print Information Doc Status & Print Information

13. #SummitNow Document Viewing  Some overlay entire header/footer including document name, title, logo, etc. Requires re-work of the doc template to remove static header/footer May require several templates for different document types/scenarios Property Info Doc Status Info Logo vary by site Created and Viewed on Date

14. #SummitNow FDA Requirements System needs to be auditable Need to prove that users can only access the right documents Need to prove that the right documents were approved by the right people. System needs to be validated Need to prove that the system meets the above requirements

15. #SummitNow What is a Change Request (CR) or Change Order (CO)? Form completed to initiate a change to a document(s) or process Needs to be signed off by people responsible for the change Provides Auditability for FDA on Reason, Description and Justification for Change as well as supporting signatures

16. #SummitNow Example of a Change Request Change cap on bottle due to leakage Identify documents affected Purchase Specification, Bill of Materials, Packaging Instructions, other documents (per product – additional changes to documents for other products) Write up instructions, dates and other information for implementing the change Need to route the change to people/functional areas charged with responsibility of approving change

17. #SummitNow Change Request – How it is used User would like to change some type of document Writes up desired Change May attach documents with changes (Creation of the Change Packet) Reviewers/Approvers Reject with Comments(Legal, Regulatory, Budget…) Approve or Approve with Changes Copy Editor or Automated Process implements Change

18. #SummitNow Quality Document System – 2011 – Alfresco 3.4 with Orbeon Although the XHTML form process was a step forward, Orbeon did not interact with repository and was not robust enough for our next step Only the final state of the form was created as a PDF copy in Alfresco. No links between CR form and attached documents -Used a homegrown workflow process instead of Alfresco workflow -Out of the Box Alfresco using folder security and no versioning -PDF ‘renditions’ were actually separate objects

19. #SummitNow Quality Document System - History - Approached TSG about Active Wizard in May 2012 - Prototype to drive requirements and business process - Development and TSG Testing complete October 2012 - Validation complete: April 2013 - Production deployment complete: May 2013 - One week migration period

20. #SummitNow HPI Search Interface for Alfresco

21. #SummitNow iPad Search

22. #SummitNow Change Request - Configurable Form A “Forms Wizard” to Complete the Form (similar to TurboTax) System will generate the form when finished System makes sure correct fields populated Simplified user interface to reduce training and improve data entry Form data could drive impacted documents Form data could drive approval requirements

23. #SummitNow Change Request Form

24. #SummitNow Workflow Best Practices To address complexity – make workflow process simpler Reduce number of user decisions Build intelligence in the system rather than in the user Allow workflow to change and adapt easily with business process

25. #SummitNow Change Request Package CR data based on user’s input

26. #SummitNow Approver Selection – Automatic Assignment Answer dictates what approvals are req’d: - High Priority Change – IQA Approval Required - Medium Priority Change – IQA Approval May be required (ask more questions) - Low Priority Change – IQA Approval Not Required

27. #SummitNow Approver Selection – User Chooses Approver User picks approvers

28. #SummitNow People Driven Workflow

29. #SummitNow Review Process Facilitating Review Route for Review workflow Factored into approval workflow Assignment of Reviewers Many just pick the reviewers Providing feedback varied Annotations Workflow comments

30. #SummitNow Annotations – During Review

31. #SummitNow Approval Interface Workflow Actions

32. #SummitNow DEMO

33. #SummitNow Future Plans Batch Records – Continue enhancing process communications with robust batch records Provide improved linking of procedures to batch records via paper / iPad delivery of instructions Validation Processes – Streamline the generation, review and approval of validation documentation Support the mining of validation documentation to support further process improvements.

34. #SummitNow Questions?

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36. Remainder are reference slides

37. #SummitNow Document Lifecycle – Aspect Based Security Lifecycle: an ordered set of states a document will move through, where each state has pre-determined meta-data, security and business rules associated with it. Implemented through the use of aspects. Example: Draft Aspect triggers behavior that sets security, status to Draft, and any other custom business logic. Consolidate code, allow for managing of lifecycle through different means. (Workflow, Share, Custom UI)

38. #SummitNow Dynamic Workflow and Activiti Using a dynamic form brings up interesting workflow requirements: Handle infinite number of workflow possibilities. Form rules can dictate any number of workflow tasks in any configuration (parallel vs. serial) Handle business rule changes without modifying template. Examples: Add or remove workflow step Make a serial process parallel or vice versa

39. #SummitNow Dynamic Workflow and Activiti In the past on other platforms, we’ve done this by generating a new workflow template on the fly based on the tripped rules Pro: It works. Cons: New template each time limits reporting capabilities, a lot of code to maintain. Activiti makes this process much simpler Main workflow process defines the overall structure. Sub process is dynamically run inside the template to facilitate workflow based on tripped rules.

40. #SummitNow Dynamic Workflow and Activiti Main Approval Process

41. #SummitNow Main Approval Process Dynamic Workflow and Activiti The workflow is started with a POJO Workflow Definition describing the workflow.

42. #SummitNow Main Approval Process Dynamic Workflow and Activiti Java (javascript) code that moves workflow documents to Pending Approval.

43. #SummitNow Main Approval Process Dynamic Workflow and Activiti Embedded Sub-Process repeats sequentially for each ‘Activity’ in the Workflow Definition. The exit condition is a variable workflowFailed == true

44. #SummitNow Main Approval Process Dynamic Workflow and Activiti Additional Workflow Definition processing to set up context variables for the parallel sub- process

45. #SummitNow Main Approval Process Dynamic Workflow and Activiti Due to limitations with nested multi-instance sub-processes a stand-alone sub-process is required.

46. #SummitNow Main Approval Process Parallel Approval Task with an exit condition that fails the sub-process, and in turn entire workflow, on one reject. Dynamic Workflow and Activiti

47. #SummitNow Main Approval Process Dynamic Workflow and Activiti Perform the appropriate service task to move workflow documents to Approved or back to Draft.

48. #SummitNow Modifying the Current Version Scenario: Properties or associations modified on current version. Issue: Version already frozen in version Store. Solution: Delete and recreate version.

49. #SummitNow Versions and Associations 0.1 VersionStore SpacesStore Create New Document 0.1 SOP-123

50. #SummitNow Versions and Associations VersionStore SpacesStore Checkout/Check In 0.1 0.2 SOP-123

51. #SummitNow Versions and Associations VersionStore SpacesStore Checkout/Check In 0.1 Add association/Change Properties 0.2 Associated Document SOP-123 SOP-456 SOP-123

52. #SummitNow Versions and Associations VersionStore SpacesStore Checkout/Check In 0.1 If you were to version… 0.3 0.2 Associated Document Checkout/Check In 0.3 SOP-123 SOP-456

53. #SummitNow Versions and Associations VersionStore SpacesStore Checkout/Check In 0.1 0.2 Associated Document Instead… 0.2 SOP-123 SOP-456

54. #SummitNow Versions and Associations VersionStore SpacesStore Checkout/Check In 0.1 0.2 Associated Document 0.2 SOP-123 SOP-456

55. #SummitNow Versions and Associations VersionStore SpacesStore Checkout/Check In 0.1 0.3 0.2 Associated Document Checkout/Check In 0.3 SOP-123 SOP-456

56. #SummitNow PDF Renditions Scenario: PDF rendition must be associated to a specific version Issue: New rendition can’t be generated after Check In. Example: Signature added to document Solution: Store Rendition as content property. Delete latest version and re-create using the embedded API.