Transcript SAFE Working Groups

SAFE Implementation Toolkit
How to use it
Implementation toolkit
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Overview
Log-in
Contents
Search
Toolkit Use
Log-out
Contents
Subject
Slide
Overview
4
Log-in
5
Toolkit Webpage Log-in
6
SAFE Website Log-in
10
General topics
17
Document Access
18
Search
24
Discussion Board
25
Toolkit Use
29
Implementation Process
30
Discover
33
Diagnose
36
Document
41
Decide
46
Deliver
53
Application Enablement
54
Issuer Selection
57
Credentialing
59
Log-out
62
Conclusion
64
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 readonly mode.
Implementation ToolkitSearch
Enter keyword(s) and select “Go”
Implementation ToolkitDiscussion Board
If you are not already in
LiveLink, go to the
Toolkit Webpage and
Select Discussion Board
Login
Implementation ToolkitDiscussion Board
If you are already in LiveLink, go to
the noted drop down and select
“Implementation”
Implementation ToolkitDiscussion Board
Select IWG Implementation
Toolkit Discussion Board
Implementation ToolkitDiscussion Board
To post a topic or reply to an
existing topic, select the
appropriate action.
Select a topic and click to
view in the discussion pane.
Toolkit Use
• The following section provides instructions
for using the toolkit to support
– The Implementation Process from Discovery
to Deployment
Organization
Discover
Diagnose
Document
Decide
Deliver
Implementation Process
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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
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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
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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
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 1Templates/a – Policies
Decide
The template to develop an
internal eIdentity Management
Procedure is found at 1Templates/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:
http://safeiwg.googlepages.com/lllogin2
or, submit a support request at the following link:
http://www.safebiopharma.org/index.php?option=com_content&task=vie
w&id=251&Itemid=421