Agile 9.3 Basics W - ETR May 2015

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.
May 2015
2 of 40
Agile Basic w/ETR Training
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

May 2015
3 of 40
Agile Homepage Components

Main toolbar
Navigation pane
May 2015
Enter Search Criteria
Agile notification
area
4 of 40
Main Toolbar Icons

Logou
t
Help
?
Back/Forwa
rd
Homepag
e
Refres
h
Search
Options
Create
Tools &
Settings
My
Settings
May 2015
5 of 40
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.
May 2015
6 of 40
Help Menu Tools

Keyboard Controls
Click on Help Icon down
arrow
to reveal Keyboard
Controls.
1/17/16
May 2015
7 of 40
Help Menu Tools

Quick Tours
Select the video you

would like to train on.
1/17/16
May 2015
8 of 40
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
May 2015
9 of 40
Icons
Part:
Assembly:
Document:
Document Tree (BOM):
Has Pending Changes:

Has Been Redlined:
Has Attachments:
May 2015
10 of 40
Notifications
To open a notification, click on the subject link
Notifications will also be sent to your email inbox
Messages require manual deletion
May 2015
11 of 40
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.
May 2015
12 of 40
My Assignments
Contains a list of assignments that require action

Not being actively used at this time
May 2015
13 of 40
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
May 2015
15 of 40
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.
May 2015
16 of 40
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.
May 2015
17 of 40
Quick Search
Quick Search using a wildcard
(*)
Result
s
May 2015
18 of 40
Custom Search
Custom Search
Button
Custom Searches allow for multiple

search criteria
Returns all objects with fields that match
the conditions of the search
May 2015
19 of 40
Custom Search
1. Select Custom Search
2. Enter
Search
Object Type
3. Enter SubType
4. Refine
search
criteria here.
May 2015
20 of 40
Advanced Search
1. Select Custom Search
2. Enter Search Object
Type
3. Enter SubType
4. Select Advanced
Search Button
1/17/16
May 2015
21 of 40
Advanced Search
After selecting the Advanced Button, the following
window appears.
Enter search
criteria here.
Select FORMAT to
personalize search
1/17/16
May 2015
22 of 40
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.
May 2015
24 of 40
Viewing Attachments
Select row and

then View
button to View
document
Click on filename to view

document using Agile
AutoVue Viewer.
May 2015
25 of 40
Agile AutoVue Document Viewer
Agile AutoVue will open and display the document.

You can PRINT, but cannot SAVE or SAVE AS the document.
May 2015
26 of 40
GET or OPEN Attachments
Select row, then

select GET or Open
button.
1/17/16
May 2015
27 of 40
When you GET or OPEN attachments, the item opens

using its NATIVE APPLICATION!
1/17/16
May 2015
28 of 40
You can EDIT, SAVE, SAVE AS, AND PRINT!

1/17/16
May 2015
29 of 40
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).
May 2015
31 of 40
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.
May 2015
32 of 40
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

May 2015
33 of 40
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.
1/17/16
May 2015
if concerns
cannot be
resolved, enter
comment with
reason for rejecting.
34 of 40
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.
1/17/16
May 2015
36 of 40
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.
May 2015
37 of 40
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.
38 of 40
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.
39 of 40
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.
May 2015
40 of 40

Agile 9.3 Basics W - ETR May 2015

Uploaded by

Copyright:

Available Formats

Agile 9.3 Basics W - ETR May 2015

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Agile 9.3 Basics W - ETR May 2015

Uploaded by

Copyright:

Available Formats

Agile Basics w/Electronic Training

Agile Basics Course Objectives:

Using the Tools

Note: Agile is Ventanas Product Lifecycle Management

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

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

Agile Homepage Components

Enter Search Criteria

Main Toolbar Icons

Logging out of Agile

Always Use the logout button:

Note: Agile sessions time out automatically after

Help Menu Tools

Help Menu Tools

Select the video you

Task Pane Shortcuts

Document Tree (BOM):

Has Pending Changes:

To open a notification, click on the subject link

Notifications will also be sent to your email inbox

Messages require manual deletion

Workflow Routings (to do

This is a list of objects that require your action.

Contains a list of assignments that require action

Product Related Documents

CQP - Quality Plans

Allows for searches using alpha and numeric

2. Enter Key Words

3. Run Quick Search

Quick search allows you to

Custom Searches allow for multiple

Viewing Documents In Agile

Viewing Attachment Versions

To view versions, click on More down

Select row and

Click on filename to view

Agile AutoVue Document Viewer

Agile AutoVue will open and display the document.

GET or OPEN Attachments

Select row, then

GET or OPEN Attachments

When you GET or OPEN attachments, the item opens

GET or OPEN Attachments

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

Approving and Rejecting Changes

Approving Change Orders

(C0XXXXX) is an electronic Document Change or Design

Change Order Approvers

Review All tabs and attachments:

Approving a Change Order

Enter your Roche Passwor

Select Approve to finalize your approval

elect REJECT tab located on cover page of change order:

Enter Your Roche Password Here

Using the Tools Icon

Tools Icon My Settings

There are many options under MY SETTINGS

Tools Icon Transfer Authority