MAP Agile Roles, Definitions and Required Training

MAP Agile Security Role For LMS Administrators: Learning

Required Curriculum(s) in Cornerstone:
(The user will need to remember the names of the roles needed and select them Assignment Group Number in
Business Definition of Role What this role can do in MAP Agile USER SHOULD NOT SELF ASSIGN - Please work with your local LMS Admin to have the curriculum listed
when filling out the Enterprise User Access request form on the IT Customer Cornerstone. Please add user to the
assigned to you.
Portal.) group.

ANALYSTS
• This role will be given the Originator-ASL, Reviewer and View-Extended role permissions as well.
Analyst - ASL • This role can only process Record Change Orders and Data Change Orders with the affected item document types of Supplier File, CORP - Global IT - MAP Agile | Change Analyst | ASL GLMSO-3112
Analysts are responsible for Supplier Location [ASL], Supplier Master [ASL] , Supplier Control [ASL], and Product/Service Segmentation [ASL]
reviewing Change Orders to ensure
compliance with configuration
management requirements. This role should be requested in addition to another Analyst role applicable to the user’s business
Analyst - Deviations • This role includes the View-Extended role permissions CORP - Global IT - MAP Agile | Change Analyst | Product GLMSO-3089
Each different analyst role has • This role can process Deviations
specific permisions in MAP Agile
that dictate what the analyst can • This role will be given the Originator-Documents, Reviewer and View-Extended role permissions as well.
or cannot review in the system. Analyst - Full • This role can process changes to all document types CORP - Global IT - MAP Agile | Change Analyst | Product GLMSO-3089
• This role can process QMS Change Orders, Record Change Orders, Data Change Orders, and Product Change Orders

• This role will be given the Originator-Documents, Reviewer and View-Extended role permissions as well.
• This role can only process Record Change Orders and Data Change Orders with the affected item document types of:
Audit/Compliance; Biocompatibility/Toxicology; Business Deliverable; Clinical; Collection; Controlled Environment; Corrective and
Analyst - Limited CORP - Global IT - MAP Agile | Change Analyst | Product GLMSO-3089
Preventive Action; Design/Develop; Environmental Health and Safety/Facilities; Equipment/Tooling; Manufacture/Produce; Marketing
Material; Medical Affairs; Microbiology; Non-Product Software/System; Preclinical; Reference; Risk Management;
Sell/Order/Distribute; Supplier Files; Support; Distributed Product; Sterilization; Train/Resource

• This role will be given Reviewer and View-Extended role permissions as well
Analyst - Material Create Request • This role can process changes to all document types CORP - Global IT - MAP Agile | Change Analyst | Product GLMSO-3089
• This role can process Material Create Requests, Product Change Orders, Record Change Orders, and Data Change Orders

Specialty Workflow - Analyst - Material Setup/Change This role can create and route MSC (Material Setup/Changes) CORP - Global IT - MAP Agile | View and Print LMS Ops439.1

CORP - Global IT - MAP Agile | View and Print LMS Ops439.1

Specialty Workflow - Analyst - PLC Status Change SC MDM This role can only create, approve, and route PLC Status Changes as analyst
CVG - Agile PLC MCO SC MDM Change Analyst - Work Instruction - System Training MORPHV1 - 332

• This role will be given the Originator-QMS, Reviewer and View-Extended role permissions as well.
• This role can only process QMS Change Orders; Data Change Orders with the affected item document types of QMS Document,
Analyst - QMS CORP - Global IT - MAP Agile | Change Analyst | QMS LMS Ops437.1
Healthcare Service Document, and Manage Quality System Record; and Record Change Orders with an affected item of Manage
Quality system Reccord or Healthcare Services Document.

CORP - Global IT - MAP Agile | Originator | RAC / RAN / RID GLMSO-3092

• This role will be given the Reviewer and View-Extended role permissions as well
Analyst - Regulatory Assessment
• This role can process changes to Regulatory Document types
(Note: This is the correct curriculum to assign. There is only one RAC/RAN/RID curriculum for MAP)

CORP - Global IT - MAP Agile | Approver / Acknowledger LMS Ops436.1

Specialty Workflow - Analyst - Supplier Change Control This role can create , approve and manage Supplier Changes MDT - Agile Supplier Change Owner Topics - System Training COMSTR1 - 603
CVG Grp Level – Agile Supplier Change Owner - Document Training – QS Regulatory Requirements COMSTR1 - 603

Specialty Workflow - Analyst - Tubing Pack Changes This role can only create, approve, and route TPC, TPS and TPA changes (Tijuana, Mex. only) CORP - Global IT - MAP Agile | View and Print LMS Ops439.1

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 MAP Agile Security Role For LMS Administrators: Learning
Required Curriculum(s) in Cornerstone:
(The user will need to remember the names of the roles needed and select them Assignment Group Number in
Business Definition of Role What this role can do in MAP Agile USER SHOULD NOT SELF ASSIGN - Please work with your local LMS Admin to have the curriculum listed
when filling out the Enterprise User Access request form on the IT Customer Cornerstone. Please add user to the
assigned to you.
Portal.) group.

APPROVERS
Approver - Material Create Request - BPM/CDA • This role can Approve, Acknowledge and Observe Material Create Requests CORP - Global IT - MAP Agile | Approver / Acknowledger LMS Ops436.1
An Approver is the person who, on
behalf of a specific functional group, is
assigned to review and approve a CORP - Global IT - MAP Agile | View and Print LMS Ops439.1
change for release. Specialty Workflow - Approver - PLC Status Change This role can only approve PLC Status Changes
CVG - Agile PLC MCO Approver/Observer (Regulatory) – Work Instruction – System Training MORPHV1 - 330

An Acknowledger performs and

completes assigned tasks, which may be Specialty Workflow - Approver - PLC Status Change (CDA) CORP - Global IT - MAP Agile | View and Print LMS Ops439.1
This role can only approve PLC Status Changes and checkout/check-in at CDA statuses
as simple as reviewing the change CVG - Agile PLC MCO CDA Approver – Work Instruction – System Training MORPHV1 - 331
and/or attachments, or it may include a
complex list of tasks. The Change Order CORP - Global IT - MAP Agile | View and Print LMS Ops439.1
Specialty Workflow - Approver - PLC Status Change (LDA) This role can only approve PLC Status Changes and checkout/check in at LDA statuses
will not be promoted to the next status CVG - Agile PLC MCO LDA Approver – Work Instruction – System Training MORPHV1 - 334
until all Acknowledgers have signed off.
CORP - Global IT - MAP Agile | View and Print LMS Ops439.1
Specialty Workflow - Approver - PLC Status Change (RDA) This role can only approve PLC Status Changes and checkout/check-in at RDA statuses
CVG - Agile PLC MCO RDA Approver – Work Instruction – System Training MORPHV1 - 335

CORP - Global IT - MAP Agile | Approver / Acknowledger

LMS Ops436.1
Reviewer
• This role can Approve, Acknowledge and Observe changes NOTE: There is an optional training for Executives. It is only available to executives with a title of Vice President or higher
(also known as Approver/Acknowledger) FOR EXECUTIVE LEVEL APPROVER - GLMSO-
and only if the VP is not the designated management representative for a QMS Entity. That training is called CORP - Global
3100
IT - MAP Agile | Executive Level Approver

ORIGINATORS • This role can modify all part types; it cannot create part types
• This role can initiate Product Change Orders, Data Change Orders, Deviation Change Orders and R&D Change Orders and can submit
Originators are responsible for Modify - Parts CORP - Global IT - MAP Agile | Originator | Product GLMSO-3091
those change orders
originating or creating the item and • This role will also be given the Reviewer and View-Extended permissions
change order. The Originator can be the
Document Owner, but it is not required.
• This role will be given the Reviewer and View Extended role permissions as well.
Each different originator role has specific Originator - ASL • This role can create ASL document types CORP - Global IT - MAP Agile | Originator | ASL GLMSO-3113
permisions in MAP Agile that dictate • This role can initiate QMS Change Orders, Record Change Orders, Data Change Orders, and Deviations
what the originator can or cannot create
and initiate in the system.
• This role will be given the Reviewer and View-Extended role permissions as well
Originator - Contract Manufacturers CORP - Global IT - MAP Agile | Originator | Product GLMSO-3091
• This role can create Contract Manufacturers

Specialty Workflow - Originator - Engineer Build Request This role can create, route, approve Engineer Build Requests CORP - Global IT - MAP Agile | View and Print LMS Ops439.1

• This role is given the Reviewer and View-Extended role permissions as well.
• This role can create most document types including QMS Document, Healthcare Service Document, and Manage Quality System
Originator - Documents Record CORP - Global IT - MAP Agile | Originator | Product GLMSO-3091
• This role can initiate QMS Change Orders, Product Change Orders, Record Change Orders, R&D Change Order, Data Change Orders,
and Deviations

• This role will be given the Reviewer and View-Extended role permissions as well.
Originator - Manufacturer CORP - Global IT - MAP Agile | Originator | Product GLMSO-3091
• This role can create Manufacturers

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 MAP Agile Security Role For LMS Administrators: Learning
Required Curriculum(s) in Cornerstone:
(The user will need to remember the names of the roles needed and select them Assignment Group Number in
Business Definition of Role What this role can do in MAP Agile USER SHOULD NOT SELF ASSIGN - Please work with your local LMS Admin to have the curriculum listed
when filling out the Enterprise User Access request form on the IT Customer Cornerstone. Please add user to the
assigned to you.
Portal.) group.

ORIGINATORS • This role will be given the Reviewer and View-Extended role permissions as well.
Originator - Manufacturer Part CORP - Global IT - MAP Agile | Originator | Product GLMSO-3091
• This role can create Manufacturer Parts
Originators are responsible for
originating or creating the item and
change order. The Originator can be the • This role will be given the Reviewer and View-Extended role permissions as well
GLMSO-3091
Document Owner, but it is not required. Originator - Material Create Request • This role can create Material Create Requests
CORP - Global IT - MAP Agile | Originator | Product

Each different originator role has specific

permisions in MAP Agile that dictate Specialty Workflow - Originator - Material Setup/Change This role can create MSC (Material Setup/Changes) CORP - Global IT - MAP Agile | View and Print LMS Ops439.1
what the originator can or cannot create
and initiate in the system.
• This role will be given the Reviewer and View-Extended role permissions as well.
Originator - Part 01-Model / 02-Product • This role can create part types 01-Model and 02-Product CORP - Global IT - MAP Agile | Originator | Product GLMSO-3091
• This role can initiate Product Change Orders, R&D Change Order, Data Change Orders, and Deviations

• This role will be given the Reviewer and View-Extended role permissions as well.
Originator - Part 03-Finished Good • This role can create part type 03-Finished Good CORP - Global IT - MAP Agile | Originator | Product GLMSO-3091
• This role can initiate Product Change Orders, R&D Change Order, Data Change Orders, and Deviations

• This role will be given the Reviewer and View-Extended role permissions as well
Originator - Part 04-Subassembly / 05-Component • This role can create part types 04-Subassembly and 05-Component CORP - Global IT - MAP Agile | Originator | Product GLMSO-3091
• This role can initiate Product Change Orders, R&D Change Order, Data Change Orders, and Deviations

• This role will be given the Reviewer and View-Extended role permissions as well
Originator - Part 06-Tooling/Manufacturing • This role can create part type 06-Tooling/Manufacturing CORP - Global IT - MAP Agile | Originator | Product GLMSO-3091
• This role can initiate Product Change Orders, R&D Change Order, Data Change Orders, and Deviations

Specialty Workflow -Originator - Planning Notification This role can create, route, approve Planning Notifications CORP - Global IT - MAP Agile | View and Print LMS Ops439.1

CORP - Global IT - MAP Agile | View and Print LMS Ops439.1

Specialty Workflow - Originator - PLC Status Change This role can only create PLC Status Changes
CVG - Agile PLC MCO Global Supply Chain Creator – Work Instruction – System Training MORPHV1 - 333

• This role is given the Reviewer and View-Extended role permissions as well.
• This role can ONLY create three Document types: QMS Document, Healthcare Service Document, and Manage Quality System
Originator - QMS CORP - Global IT - MAP Agile | Originator | QMS LMS Ops438.1
Record
• This role can initiate four Change types: QMS Change Order, Record Change Order, Data Change Order, and Deviation

• This role will be given the Originator - Regulatory Impact Decision – Change, Reviewer and View-Extended role permissions as well CORP - Global IT - MAP Agile | Originator | RAC / RAN / RID GLMSO-3092
Originator - Regulatory Assessment - Change
• This role will initiate the Regulatory Assessment Change (RAC) process formerly known as the PCN CORP - Global IT - MAP Agile | Approver / Acknowledger LMS Ops436.1

• This role will be given theOriginator - Regulatory Impact Decision - New Product, Reviewer and View-Extended role permissions as
CORP - Global IT - MAP Agile | Originator | RAC / RAN / RID GLMSO-3092
Originator - Regulatory Assessment - New Product well.
CORP - Global IT - MAP Agile | Approver / Acknowledger LMS Ops436.1
• This role will initiate the Regulatory Assessment New Product (RAN) process formerly known as the NPN

• This role will be given the Reviewer and View-Extended role permissions as well CORP - Global IT - MAP Agile | Originator | RAC / RAN / RID GLMSO-3092
Originator - Regulatory Impact Decision - Change
• This role can create the Regulatory Impact Decision - Change document CORP - Global IT - MAP Agile | Approver / Acknowledger LMS Ops436.1

• This role will be given the Reviewer and View-Extended role permissions as well CORP - Global IT - MAP Agile | Originator | RAC / RAN / RID GLMSO-3092
Originator - Regulatory Impact Decision - New Product
• This role can create the Regulatory Impact Decision - New Product document CORP - Global IT - MAP Agile | Approver / Acknowledger LMS Ops436.1

Specialty Workflow - Originator - Tubing Pack Changes This role can create, approve TPC, TPS and TPA changes (Tijuana, Mex. only) CORP - Global IT - MAP Agile | View and Print LMS Ops439.1

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 MAP Agile Security Role For LMS Administrators: Learning
Required Curriculum(s) in Cornerstone:
(The user will need to remember the names of the roles needed and select them Assignment Group Number in
Business Definition of Role What this role can do in MAP Agile USER SHOULD NOT SELF ASSIGN - Please work with your local LMS Admin to have the curriculum listed
when filling out the Enterprise User Access request form on the IT Customer Cornerstone. Please add user to the
assigned to you.
Portal.) group.

VIEWERS
• This role can see old, current, and pending revisions of documents
View - Extended CORP - Global IT - MAP Agile | View and Print LMS Ops439.1
• This role can download and print attachments
The View roles offer access to MAP
Agile on a limited basis. These
people do not need to initiate,
create, approve or manage any
items or changes, and only need • This role can only see the current released revision of documents
View - Read Only • This role cannot see older revisions of documents CORP - Global IT - MAP Agile | View and Print LMS Ops439.1
access to limited information.
• This role cannot download nor print attachments from AutoVue

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