Agile Basics w/Electronic Training

Record (ETR)
May 2015

Agile Basics Course Objectives:

Access/Logging in

Viewing Documents

Navigating

Approving Changes

Conducting Searches

Using the Tools

icon

Note: Agile is Ventanas Product Lifecycle Management

(PLM) system. It is a tool used to manage all product and
quality system information from product concept through
design to manufacturing and retirement.
VQS procedures for Design Control (CQP04) and Document
& Data Control (CQP05) define tool usage and the various
supporting processes.
Work instructions for the DC/DCO/DDCO workflows in Agile
are listed under CQP05.
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Accessing Agile

om the Ventana Intranet site home page select the following. . . .

Step 1

Step 2

Step 3
Roche ID
Roche Password

OR - click on the Agile logo in the right-hand side of the page

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Agile Homepage Components

Main toolbar

Navigation pane

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Enter Search Criteria

Agile notification
area
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Main Toolbar Icons

Logou
t
Help
?

Back/Forwa
rd
Homepag
e

Refres
h

Search
Options

Create

Tools &
Settings
My
Settings

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Logging out of Agile

Always Use the logout button:

Agile will recognize your session has ended and save all
work
Using the X box to exit Agile may result in loss of
unsaved work

Note: Agile sessions time out automatically after

25 minutes. This is a corporate security
requirement.
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Help Menu Tools

Keyboard Controls
Click on Help Icon down
arrow
to reveal Keyboard
Controls.

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Help Menu Tools

Quick Tours

Select the video you

would like to train on.

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Task Pane Shortcuts

1. Searches: contains
links to Saved searches
and Global searches
2. My Bookmarks
(shortcuts): user creates
links to objects in the
system
3. Recently Visited
(History): a list of
recently viewed objects

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Icons

Part:

Assembly:

Document:

Document Tree (BOM):

Has Pending Changes:

Has Been Redlined:
Has Attachments:

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Notifications

To open a notification, click on the subject link

Notifications will also be sent to your email inbox

Messages require manual deletion

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Workflow Routings (to do

list):

This is a list of objects that require your action.

To view an object, click on the link under the Number
column.
Once action is completed, the object will no longer appear
in the list.
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My Assignments

Contains a list of assignments that require action

Not being actively used at this time

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Agile Searches

Searches
Quick, Custom and Advanced Search
Search objects include all Agile items and attributes:
Quality Documents

Product Related Documents

QM - Quality Manual
WI - Work instructions
FM- Forms
Parts
FT- Formats
GD Guidance Documents

Quality Records

OP Operating Procedures
MWI Manufacturing Work Instructions

Business Documents

CQP - Quality Plans

SOPs Human Resources (Search using
SOP*
TD - Temporary Deviations
(scroll through results)
CO - Change Orders
OPs SHE, Facilities, Legal, Finance
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Quick Search

Quick Search
Button

Allows for searches using alpha and numeric

characters, partial and complete words, etc.
Text must contain the number that is sought or a word
in the objects description (example: 95102, training,
esd, probes, ish, sish, egfr, etc.).
The word can be anywhere within the field.

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Quick Search
1. Select Item

2. Enter Key Words

3. Run Quick Search

Quick search allows you to

search across all content
or you can filter by specific
object type.

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Quick Search
Quick Search using a wildcard
(*)

Result
s
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Custom Search
Custom Search
Button

Custom Searches allow for multiple

search criteria
Returns all objects with fields that match
the conditions of the search
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Custom Search
1. Select Custom Search

2. Enter
Search
Object Type
3. Enter SubType

4. Refine
search
criteria here.

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Advanced Search
1. Select Custom Search
2. Enter Search Object
Type
3. Enter SubType

4. Select Advanced
Search Button

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Advanced Search
After selecting the Advanced Button, the following
window appears.

Enter search
criteria here.

Select FORMAT to
personalize search

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Viewing Documents In Agile

Viewing Attachment Versions

Click on
Attachments tab to
view attached
documents.

To view versions, click on More down

arrow. Then, click on View Versions.

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Viewing Attachments

Select row and

then View
button to View
document

Click on filename to view

document using Agile
AutoVue Viewer.

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Agile AutoVue Document Viewer

Agile AutoVue will open and display the document.

You can PRINT, but cannot SAVE or SAVE AS the document.
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GET or OPEN Attachments

Select row, then

select GET or Open
button.

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GET or OPEN Attachments

When you GET or OPEN attachments, the item opens

using its NATIVE APPLICATION!
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GET or OPEN Attachments

You can EDIT, SAVE, SAVE AS, AND PRINT!

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Approving and Rejecting Changes

Approving Change Orders

(C0XXXXX) is an electronic Document Change or Design

Change Order.
Open and review the affected items on the change order.
You can add additional redlines to the documents, if
desired.
Approve or Reject change (enter comment if rejecting).
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Change Order Approvers

Review All tabs and attachments:

Open and Review all tabs and attachments be aware that
Agile
keeps a detailed history of activity for the change order,
including getting attachments, viewing and printing.
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Approving a Change Order

Select APPROVE tab located on cover page of
change order:

Enter your Roche Passwor

Enter Your Roche Password Here

Select Approve to finalize your approval

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To Reject

elect REJECT tab located on cover page of change order:

Enter Your Roche Password Here

DO NOT REJECT
until you have
contacted the
Originator or
Change Sponsor to
discuss your
concerns.

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if concerns
cannot be
resolved, enter
comment with
reason for rejecting.
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Using the Tools Icon

Tools Icon My Settings

Select My Settings Icon

There are many options under MY SETTINGS

including:
TRANSFER AUTHORITY to another user when you
are out of the office.
BOOKMARK, SUBSCRIBE, view USER GROUPS, etc.
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Tools Icon Transfer Authority

After selecting MY SETTINGS icon, select TRANSFER AUTHORITY

Select ADD button to

create Transfer
Authority.

Note: Set to All Change Orders - System defaults to

Global. All Activities which does not transfer change
orders.
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Subscriptions and/or Bookmarks

1. Click on the
ACTIONS button and
choose the selection
you prefer.

May 2015

2. You can BOOKMARK or

SUBSCRIBE to any item in
Agile.

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Accessing Your Agile Electronic

Training
Login
to Agile
then:
Record
(ETR)
Click on the Tools and Settings icon
Click on My Training
ETR Window appears asking for login
credentials.

May 2015

Note: You can also login to the ETR via the Agile
intranet page.
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Thank you for completing Agile

Basics!
It is best to read and complete the Electronic Signature Form
(FM0200-100) prior to using the ETR the first time.
Use the Agile test environment to practice. Visit the Agile
Education Center for system information, helpful how tos"
and self-service assistance.
Contact an Agile Subject Matter Expert (SME) in your
department or Jeff Dobbins, David Vinas or a Change
Analyst.

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