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Tool Kit Training (PowerPoint)

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Tool Kit Training (PowerPoint)

  1. 1. SAFE Implementation Toolkit How to use it
  2. 2. Implementation toolkit <ul><li>Overview </li></ul><ul><li>Log-in </li></ul><ul><li>Contents </li></ul><ul><li>Search </li></ul><ul><li>Toolkit Use </li></ul><ul><li>Log-out </li></ul>
  3. 3. Contents 64 Conclusion 62 Log-out 59 Credentialing 57 Issuer Selection 54 Application Enablement 53 Deliver 46 Decide 41 Document 36 Diagnose 33 Discover 30 Implementation Process 29 Toolkit Use 25 Discussion Board 24 Search 18 Document Access 17 General topics 10 SAFE Website Log-in 6 Toolkit Webpage Log-in 5 Log-in 4 Overview Slide Subject
  4. 4. Implementation toolkit <ul><li>This presentation provides the user: </li></ul><ul><ul><li>An overview of the SAFE toolkit and instructions to use the presentation most effectively </li></ul></ul>
  5. 5. Implementation Toolkit Log-in <ul><li>This section provides the user insight into two methods to log-in to the toolkit </li></ul><ul><ul><li>Via the Toolkit Webpage off the SAFE Website </li></ul></ul><ul><ul><li>From within LiveLink </li></ul></ul>
  6. 6. Toolkit Webpage Log-in <ul><li>Log-in from the Toolkit Webpage </li></ul><ul><li>This section explains how to log in to the toolkit from the Toolkit Webpage </li></ul>
  7. 7. Toolkit Webpage Log-in Click here to go to the toolkit
  8. 8. Toolkit Webpage Log-in <ul><li>On the LiveLink Log-in screen enter your user name and password: </li></ul>
  9. 9. Toolkit Webpage Log-in <ul><li>You arrive at the toolkit: </li></ul>The folder structure was developed to coincide with the Requirements Specification for the toolkit. It arranges documents either type of document or the type of activity supported.
  10. 10. SAFE Website Login <ul><li>This section provides directions to log-in to the toolkit from the SAFE-BioPharma webpage </li></ul>
  11. 11. SAFE Website Login Click on LiveLink login
  12. 12. SAFE Website Login Enter User Name and Password. Click on the lock
  13. 13. SAFE Website Login Select SAFE Community Shared Documents
  14. 14. SAFE Website Login Select Working group, Implementation
  15. 15. SAFE Website Login Select Implementation
  16. 16. SAFE Website Login Select SAFE Implementation Toolkit
  17. 17. General topics <ul><li>This section provides guidance for use of the toolkit in some general areas: </li></ul><ul><ul><li>Document access </li></ul></ul><ul><ul><li>Search capabilities </li></ul></ul><ul><ul><li>Discussion board use </li></ul></ul>
  18. 18. Document Access <ul><li>This section shows how to access documents and how to use the actions pick list </li></ul>
  19. 19. Document Access Note the identification of the number of items in a given folder. Where there are none yet, these folders will be populated as part of Toolkit enhancements
  20. 20. Document Access To view the contents of a folder, click it. In this case Templates
  21. 21. Document Access Open the Policies folder
  22. 22. Document Access Select the actions icon for the document with you wish to work.
  23. 23. Document Access This will display the pick list of available actions you may take. The contents depends on your level of permission and you may not see all the example actions. Two of the most likely actions are “Download “ and “View”. “Download” will download a copy of the document to your machine. “View” will display the document in the LiveLink view for you to read. This is a read-only mode.
  24. 24. Implementation Toolkit- Search Enter keyword(s) and select “Go”
  25. 25. Implementation Toolkit- Discussion Board If you are not already in LiveLink, go to the Toolkit Webpage and Select Discussion Board Login
  26. 26. Implementation Toolkit- Discussion Board If you are already in LiveLink, go to the noted drop down and select “Implementation”
  27. 27. Implementation Toolkit- Discussion Board Select IWG Implementation Toolkit Discussion Board
  28. 28. Implementation Toolkit- Discussion Board Select a topic and click to view in the discussion pane. To post a topic or reply to an existing topic, select the appropriate action.
  29. 29. Toolkit Use <ul><li>The following section provides instructions for using the toolkit to support </li></ul><ul><ul><li>The Implementation Process from Discovery to Deployment </li></ul></ul>
  30. 30. Implementation Process <ul><li>Discover - A prospective Member organization becomes aware of the existence of SAFE-BioPharma, Assn and wishes to “discover” more about what it is and what “need” it meets. </li></ul><ul><li>Diagnose - This phase relates to using the various documents to review the options available to implement a public key infrastructure (PKI) infrastructure. </li></ul><ul><li>Document - The documents that support this phase provide the background and knowledge required to understand, from a SAFE perspective, subjects such as electronic identity management, how to use and verify digital signatures on documents, the contract structure and rights and responsibilities of the various participants that subscribe to the SAFE Standard. Other documents provide insight into legal and regulatory rationale for a structured approach to the use of electronic records, how SAFE and the FDA interact and a legal analysis of the use of digital signatures. All this information adds to the base of knowledge supporting the implementation of SAFE-enabled applications and can be used by both non-Member and Member companies. </li></ul>
  31. 31. Implementation Process <ul><li>Decide - The documents supporting this phase are more specific to supporting the actual decision to implement. These document include templates for SOP’s, template project plans, SAFE functional and technical specifications to assist in identifying the requirements that must be met by any SAFE-enabled implementation and checklists to assist the project planner and team. </li></ul><ul><li>Deliver - Within this phase of implementation there are three separate, but closely related sub-phases and each is supported by a set of tools in the toolkit. </li></ul>
  32. 32. Deliver Sub-phases <ul><li>Application enablement - The documents supporting this phase provide guidance regarding compliance with the SAFE Standard and also 21CFR, Pt 11, as well as implementation methodology agnostic templates model documents supporting system lifecycle development. These later documents may be modified to meet the specific internal methodology that any specific implementing organization might use. </li></ul><ul><li>Issuer Selection - The documents supporting this phase specifically support the decision to either implement an internal PKI or to seek the services of an external third party Issuer (which includes a registration authority (RA) and a certification authority (CA). The documents include those form the SAFE Standard document set that specify the requirements for an RA and CA and end user devices which host the end user digital identity certificates and the specific technical documents that describe the SAFE certificate policies and profiles that a CA must meet in order to work within the SAFE system. The final document in this section describes the process an internal PKI must complete in order to cross certify with the SAFE Bridge Certification Authority and be part of the SAFE system of trust. </li></ul><ul><li>Credentialing – The documents supporting this final phase include the current documents that support the provisioning of credentials to users using the SAFE Registration and Certificate configuration Authority (RACCA) system. If SAFE adds additional credentialing mechanisms, documents will be added. </li></ul>
  33. 33. Discover Specific documents supporting this phase of implementation may be found in the noted folders.
  34. 34. Discover In the 7 - Whitepapers folder
  35. 35. Discover In the 8 - Case Studies folder
  36. 36. Diagnose Documents supporting this phase of implementation may be found in the noted folders
  37. 37. Diagnose In the 3 - eRecords Management Approach folder
  38. 38. Diagnose In the 4 - Business Cases folder
  39. 39. Diagnose In the Legal sub-folder of the 5 - Risk Management Analyses folder
  40. 40. Diagnose In the Regulatory sub-folder of the 5 - Risk Management Analyses folder
  41. 41. Document Documents supporting this phase of implementation may be found in the noted folders
  42. 42. Document Select the sub-folder to see the SAFE contractual agreements
  43. 43. Document
  44. 44. Document These documents are located at 11 - SAFE Technology Architecture/SAFE Technical Specs, Process Guidelines, Policies /Policies
  45. 45. Document These documents are found in 11 - SAFE Technology Architecture/SAFE Technical Specs, Process Guidelines, Policies /Process Guidelines
  46. 46. Decide Documents supporting the Decision Phase can be found in the noted folders.
  47. 47. Decide These documents are found at 11 - SAFE Technology Architecture/SAFE Technical Specs, Process Guidelines, Policies /Process Guidelines and provide technical requirements for SAFE-enabled systems.
  48. 48. Decide These Project Plan templates can be found at 1-Templates/c – Project Plans
  49. 49. Decide Templates for internal policies required for implementation can be found at 1-Templates/a – Policies
  50. 50. Decide The template to develop an internal eIdentity Management Procedure is found at 1-Templates/a – Procedures
  51. 51. Decide Documents supporting initial compliance planning can be found in the 6 - Compliance folder.
  52. 52. Decide The SAFE Functional Requirements that must be met as part of an implementation can be found in this document located at 11 - SAFE Technology Architecture/SAFE Technical Specs, Process Guidelines, Policies /Process Guidelines/Tech Specs
  53. 53. Deliver <ul><li>There are three sub-phases in the Deliver Phase </li></ul><ul><ul><li>Application Enablement </li></ul></ul><ul><ul><li>Issuer Selection </li></ul></ul><ul><ul><li>Credentialing </li></ul></ul>
  54. 54. Application Enablement Technical requirements that must be met as part of an implementation can be found in this document located at 11 - SAFE Technology Architecture/a - SAFE Technical Specs, Process Guidelines, Policies /Tech Specs
  55. 55. Application Enablement These documents supporting compliance requirements to ensure compliance with 21CFR, Part 11 are found in the 6 - Compliance folder.
  56. 56. Application Enablement Templates for the development of documents supporting a generic SDLC can be found in these subfolders located at 1-Templates/d – SDLC Documents
  57. 57. Issuer Selection Documents supporting Issuer activities with the SAFE Bridge Certificate Authority can be found at 11 – SAFE Technology Architecture/b – Implementation Technology and Infrastructure Options/ Enablement - Issuer
  58. 58. Issuer Selection SAFE Technical Specifications supporting Issuer activities can be found at 11 - SAFE Technology Architecture/a - SAFE Technical Specs, Process Guidelines, Policies /Process Guidelines/Tech Specs
  59. 59. Credentialing Documents supporting Credentialing are found in the 11 - SAFE Technology Architecture/c –Credentialing Options subfolder
  60. 60. Credentialing As additional credentialing sources are added, we will add new sub-folders
  61. 61. Credentialing
  62. 62. Toolkit Log-out To log out of LiveLink, select Log-out
  63. 63. Toolkit Log-out Select Log-out
  64. 64. Conclusion <ul><li>This completes the overview of the SAFE Implementation toolkit, </li></ul><ul><li>If you have questions, concerns or comments please use this link and enter a new topic on the discussion board: </li></ul><ul><li>http://safeiwg.googlepages.com/lllogin2 </li></ul><ul><li>or, submit a support request at the following link: </li></ul><ul><li>http://www.safe-biopharma.org/index.php?option = com_content&task = view&id =251&Itemid=421 </li></ul>

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