SAFE Implementation Toolkit How to use it

Implementation toolkit Overview Log-in Contents Search Toolkit Use Log-out

Contents SubjectSlide Overview4 Log-in5 Toolkit Webpage Log-in6 SAFE Website Log-in10 General topics17 Document Access18 Search24 Discussion Board25 Toolkit Use29 Implementation Process30 Discover33 Diagnose36 Document41 Decide46 Deliver53 Application Enablement54 Issuer Selection57 Credentialing59 Log-out62 Conclusion64

Implementation toolkit This presentation provides the user: –An overview of the SAFE toolkit and instructions to use the presentation most effectively

Implementation Toolkit Log-in This section provides the user insight into two methods to log-in to the toolkit –Via the Toolkit Webpage off the SAFE Website –From within LiveLink

Toolkit Webpage Log-in Log-in from the Toolkit Webpage This section explains how to log in to the toolkit from the Toolkit Webpage

Toolkit Webpage Log-in Click here to go to the toolkit

Toolkit Webpage Log-in On the LiveLink Log-in screen enter your user name and password:

Toolkit Webpage Log-in You arrive at the toolkit: 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.

SAFE Website Login This section provides directions to log-in to the toolkit from the SAFE-BioPharma webpage

SAFE Website Login Click on LiveLink login

SAFE Website Login Enter User Name and Password. Click on the lock

SAFE Website Login Select SAFE Community Shared Documents

SAFE Website Login Select Working group, Implementation

SAFE Website Login Select Implementation

SAFE Website Login Select SAFE Implementation Toolkit

General topics This section provides guidance for use of the toolkit in some general areas: –Document access –Search capabilities –Discussion board use

Document Access This section shows how to access documents and how to use the actions pick list

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

Document Access To view the contents of a folder, click it. In this case Templates

Document Access Open the Policies folder

Document Access Select the actions icon for the document with you wish to work.

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.

Implementation Toolkit- Search Enter keyword(s) and select “Go”

Implementation Toolkit- Discussion Board If you are not already in LiveLink, go to the Toolkit Webpage and Select Discussion Board Login

Implementation Toolkit- Discussion Board If you are already in LiveLink, go to the noted drop down and select “Implementation”

Implementation Toolkit- Discussion Board Select IWG Implementation Toolkit Discussion Board

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.

Toolkit Use The following section provides instructions for using the toolkit to support –The Implementation Process from Discovery to Deployment

Implementation Process 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. Diagnose - This phase relates to using the various documents to review the options available to implement a public key infrastructure (PKI) infrastructure. 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.

Implementation Process 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. 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.

Deliver Sub-phases 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. 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. 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.

Discover Specific documents supporting this phase of implementation may be found in the noted folders.

Discover In the 7 - Whitepapers folder

Discover In the 8 - Case Studies folder

Diagnose Documents supporting this phase of implementation may be found in the noted folders

Diagnose In the 3 - eRecords Management Approach folder

Diagnose In the 4 - Business Cases folder

Diagnose In the Legal sub-folder of the 5 - Risk Management Analyses folder

Diagnose In the Regulatory sub-folder of the 5 - Risk Management Analyses folder

Document Documents supporting this phase of implementation may be found in the noted folders

Document Select the sub-folder to see the SAFE contractual agreements

Document

These documents are located at 11 - SAFE Technology Architecture/SAFE Technical Specs, Process Guidelines, Policies /Policies

Document These documents are found in 11 - SAFE Technology Architecture/SAFE Technical Specs, Process Guidelines, Policies /Process Guidelines

Decide Documents supporting the Decision Phase can be found in the noted folders.

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.

Decide These Project Plan templates can be found at 1-Templates/c – Project Plans

Decide Templates for internal policies required for implementation can be found at 1- Templates/a – Policies

Decide The template to develop an internal eIdentity Management Procedure is found at 1- Templates/a – Procedures

Decide Documents supporting initial compliance planning can be found in the 6 - Compliance folder.

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

Deliver There are three sub-phases in the Deliver Phase –Application Enablement –Issuer Selection –Credentialing

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

Application Enablement These documents supporting \compliance requirements to ensure compliance with 21CFR, Part 11 are found in the 6 - Compliance folder.

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

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

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

Credentialing Documents supporting Credentialing are found in the 11 - SAFE Technology Architecture/c – Credentialing Options subfolder

Credentialing As additional credentialing sources are added, we will add new sub-folders

Credentialing

Toolkit Log-out To log out of LiveLink, select Log-out

Toolkit Log-out Select Log-out

Conclusion This completes the overview of the SAFE Implementation toolkit, If you have questions, concerns or comments please use this link and enter a new topic on the discussion board: or, submit a support request at the following link: biopharma.org/index.php?option=com_content&task=vie w&id=251&Itemid=421