OPM Product Development Concept To Release r12

OPM Product Development Concept to Release
Demo Script (Internal)
Copyright Oracle Corporation, 2003. All rights reserved.
Life Sciences - Concept to Release

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Table of Contents
Life Sciences - Concept to Release [EDUM0275] 22-Oct-2004....................................................................i
OPM Product Development - Concept to Release......................................................................................................1
Enable Formula Version Control................................................................................................................................5
Verify/Enable Profile Options for Formula/Recipe Workflows and ERES Approval for user: Process_Ops...........7
Create a Pilot Routing (For Chemicals Demo only)...................................................................................................9
Verify Default Lab Profile........................................................................................................................................11
Verify/Enable Profile Options for Formula/Recipe Workflows and ERES Approval for user: Process..................12
Start Demo from adsweb...........................................................................................................................................14
Create a New Formula..............................................................................................................................................15
Setup Technical Data................................................................................................................................................17
Analyze Formula Using Simulator...........................................................................................................................20
Request Approval for General Use...........................................................................................................................22
Approve Formula Status Change..............................................................................................................................23
Create a New Formula Version.................................................................................................................................24
View Formulas in Formulator Workbench...............................................................................................................26
Scale Formula/Version..............................................................................................................................................27
Request Approval for General Use...........................................................................................................................29
Approve Formula Status Change..............................................................................................................................30
Create Routing/Version to Accommodate Scaled Formula......................................................................................31
Establish Routing Step-Dependencies using Routing Designer...............................................................................33
Create New Recipe from Approved Formula/Routing/Operation............................................................................36
Approve Recipe Status Change.................................................................................................................................39
Create a Recipe Validity Rule...................................................................................................................................40
Approve Recipe Validity Rule Status Change..........................................................................................................42
Flowchart..................................................................................................................................................................44

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OPM Product Development - Concept to Release

Document Control
Date
Owner
App
Release
Version
Change Reference
12-Dec-2003
Bruce.Johnson
11.5.9r2
v1.0
New Document
13-Dec-2003
Premanand Bhat
11.5.9r2
v1.0
Script Reviewed and Improvements

suggested
22-Oct-2004
Madhavi
Dharmadhikari
11.5.10
V1.1
Updated for enhanced ERES setups and the

new Simulator feature.
Revised to use the latest EDU template and
tutor guidelines.
05-Feb-2006
Madhavi
Dharmadhikari
11.5.10r
3
V1.0
Renamed the script to use a more generic

title. Enhanced the script to use industry
variables. It currently has industry
variables for Life Science-Pharmaceuticals
and Chemicals. Data for Chemicals is
newly added for this release.
25-Mar-2007
Madhavi
Dharmadhikari
12.0
v1.0
Enhanced for changes due to inventory

convergence in R12.
Objective
The purpose of this Flow demo script is to demonstrate the Business Flow: Concept to Release
for the Life Sciences and Chemicals Industry.
What's New?
This script now includes industry variables, addressing the business flow, for Life Sciences and
Chemicals industries.
Pitfalls
None
Assumptions
None
Related Business Flows (Optional)


Page 1
This script maps to the following Business Flow solutions:
Concept to Release
Related Documents
http://globalxchange.oraclecorp.com/demodocs >Industry Documentation Folder > Saved Search
- Pharma and Life Sciences Demodocs - All
OPM Quality Management - New Product Quality Management Development
Demo Background (For Life Sciences)

As new products become ever more complex, regulation more onerous and the supply chain
increasingly global, achieving excellence in manufacture and supply is critical to organizational
success.
Reducing the product development cycle
On average, pharmaceutical companies invest $500 million and close to 14 years to bring a
single new drug from concept to release. It is critical to retain patent protection for marketing
and amortization of the initial investment by reducing the time between the initial drug discovery
and the approval of the new drug.
Secure research and development investments
Information infrastructure is key to capturing and exchanging critical research and development
data. Researchers need to spend more time on drug discovery than on information management.
An integrated information technology system is needed that follows cGMP and GLP practices.
The solution needs to provide the documentation that leads to early product validation.
Survive clinical trails
Only five percent of new drugs survive all three phases of clinical trials. Manufacturers must
cope with the high costs of process safety, total quality, and procedural complexities associated
to study design, randomization, labeling, tracing, manufacturing, and packaging clinical trial
samples. The process requires a dedicated infrastructure to manage a sample from formulation
through administration and clinical data capture, to final storage as evidence.
Pilot Production Simulation
At completion of the clinical trials, the pilot run provides the manufacturing engineering
information needed to optimize design for manufacture and design for assembly. In many cases,
pilots are run during the clinical trial phase to provide the information needed for scale-up to the
full production run.
Scale-up to Full Production Run

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Full-scale production and validation costs are reduced significantly when the pilot run is
designed to parallel full production run. In product scale-up, modifications are made to the recipe
to accommodate material resource availability, environmental variables (such as heat, humidity,
and atmospheric pressure), and human resource availability.
Launch
To launch a product successfully, the following issues must be considered:
Identify personnel requirements to ensure the proper number and training of launch
resources
Prepare core launch materials including development of medical information and

communicating with global network team to promote the drug product
Collaborate across departments for clear and timely communication of product quality
Develop responses to adverse event complaints
Ensure training is written and oral presentations are rehearsed to gain consumer
confidence
Launch the product
Provide post-launch evaluations and monitor medical queries and trends
Process/product improvement
The ideal product improvement workflow links autonomous groups, and then collects and routes
data, state changes, and requests into one centralized system. It automatically maintains complex
business rules involving multiple departments and approvals.
Implementing such an ideal workflow without management tools is beyond the capability of
most organizations. The need for a custom solution to conform to the unique complexity
requirements outstrips the capabilities of available systems. For example, the ideal workflow
may include a dozen parallel and cyclical processes in which a product is iteratively tested in one
department, and enhanced to meet new requirements in others. It may need to allow one defect to
apply to many sub-parts of a product, and therefore may need to be assigned to multiple groups
for resolution.
Note: This is an opportunity to explain: The Role of Oracle Workflow and Discoverer.
Line extensions
After a product launch, the focus shifts to tracking uptake and utilization. It is also essential to
understand evolving perceptions and influence of messages. Finally, late life-cycle issues may
include product re-positioning, message revitalization or the development of product-line
extensions. Line extensions can include positioning for new, improved, or reformulated versions
of the product.
Patent expiry

Page 3
Many commercially important products will face generic competition within the next five years.
Products with aggregate sales of over $20 billion in the year 2000 have patent expirations
between 2000 and 2005.
Defense against generics
Generic drugs now account for approximately 47% of all pharmaceutical prescriptions, up from
about 13% in 1980 and 19% in 1984. Market penetration by generics has become increasingly
rapid. Preparation for reformulation, repositioning, and line extension is essential for
profitability.
Retirement from marketplace
Law ultimately determines the life cycle for a pharmaceutical product. In the United States, the
date of approval of generic competitors is directly tied to patent expiration for many important
pharmaceuticals. Some U.S. pharmaceutical patents can be extended to recover time lost in the
regulatory approval process. Market exclusivitydesigned by the U.S. Congress to provide
incentives for the development of new drugscan also extend product life independent of patent
protection. The statutory basis for approval of generic products may also prevent approval of
these products even where patents and market exclusivity do not apply.
The Entire Pharmaceutical Life Cycle:
Sequence
Activity
Stage
1.
Candidate drug
DEVELOPMENT
2.
Research and development
DEVELOPMENT
3.
Clinical trials
DEVELOPMENT
4.
Pilot
ROLL-OUT
5.
Scale-up
ROLL-OUT
6.
Launch
ROLL-OUT
7.
Process/product improvement
MATURITY
8.
Line extensions
MATURITY
9.
Patent expiry
MATURITY
10.
Defense against generics
DEFENSE
11.
Retirement from marketplace
DEFENSE
This scenario begins with activity #4 at the beginning of the rollout stage. This stage is after the
pharmaceutical product has passed initial clinical trials, and planning has started for pilot and
full-scale production in preparation for the date when NDA approval is granted. In this scenario,
there are no requirements to provide special product handling/tracking capabilities for supporting
blind or double blind studies, as there would have been during the clinical research phases.
Pre Demo Steps (Optional)


Page 4
Enable Formula Version Control

Enable Formula Version Control
1.
Log into Oracle Applications Portal

Field
2.
Life Sciences-Pharmaceuticals
Username
Process_ops
Process_ops
Password
Welcome
Welcome
Responsibility
Product Development Security

Manager
Product Development Security

Manager
Query Organization Parameters for PR1
(N) Organization Parameters
(I) Find
Enter Criteria
Field
Organization
3.
PR1
Chemicals
PR1
(B) Find
Enable Formula Version Control for Organization PR1
(T) Formula
Field
Version Control
4.
Chemicals
Yes
(I) Save, if change made.
(I) Close Form
Chemicals
Yes
Query Organization Parameters for Lab Organization
(N) Organization Parameters
(I) Find
Enter Criteria
Field

Page 5
Chemicals
Organization
5.
LA1
LA2
(B) Find
Enable Formula Version Control for Lab Organization
(T) Formula
Field
Version Control
Yes
(I) Save, if change made.
(I) Close Form
Chemicals
Yes

Page 6
Verify/Enable Profile Options for Formula/Recipe Workflows and

ERES Approval for user: Process_Ops
ERES Approval for user: Process_Ops
Disclaimer: Please note that the ADS E-Records and Workflow event profile options and
related setup were created as a demonstration solution to allow SCs to quickly enable and
disable the events, and should not be portrayed to prospects as a standard part of the
applications or as an implementation example.
6.
Switch Responsibility
Field
Responsibility
7.
Process Engineer
Chemicals
Process Engineer
Query the Profile Options for Formula/Recipe Workflows and ERES Approval
(N) Others > Profile Options
Query by Example
Field
Profile Name
ADSP%
Chemicals
ADSP%
List of profile options will be displayed.

8.
Verify/Enable the Profile Options for Formula/Recipe Workflows and ERES Approval
Verify/Change the User Value for the profile options

Field
Chemicals
Profile Name
ADSP:GMD ERES Formula

Status Change Approval

User Value
Yes
Yes
Profile Name
ADSP:GMD ERES Recipe Status

Change Approval
ADSP:GMD ERES Recipe

User Value
Yes
Yes
Profile Name

Validity Status Change Approval

Validity Status Change
Approval

Page 7
User Value
(I) Save
(I) Close Form
Yes
Yes

Page 8
Create a Pilot Routing (For Chemicals Demo only)

Create a Pilot Routing (For Chemicals Demo Only)
Perform this step only for the chemicals industry demo. A pilot routing for the item/recipe
used in this demo will be seeded in the next release.
9.
Find an existing routing to copy
(N) Process Routings
Select organization
Field
Organization
Chemicals
PR1
(I) Find
Field
Routing / Version
Chemicals
3101 / 1
(B) Find
The routing details are displayed.
10. Copy the routing to create a new one
Place the cursor in the top section of the screen (i.e.: click in the routing field)
(I) New
Click on the green + at the top of the screen to create a new record
(M) Edit > Duplicate > Record Above
Change the name of the routing

Field
Chemicals
Routing
3101-PILOT <or name of your

choice>
Version
1 or unique version
(I) Save
Notice that the status of the routing is New.

Page 9
11. Approve Routing
(M) Actions-> Change Status
Select new status

Field
Chemicals
Change Status To
Approved for General Use
(B) OK
Routing status changes to "Approved for General Use".
(I) Close Form
12. Logout
Exit Oracle Applications
(H) Logout

Page 10
Verify Default Lab Profile

Verify Default Lab Profile
13. Log into Oracle Applications Portal
Field
Chemicals
Username
process
process
Password
welcome
welcome
Responsibility
System Administrator
System Administrator
14. Verify Profile
(N) Profile > System
Enter search criteria

Field
Chemicals
User
PROCESS
PROCESS
Profile
GMD: Default Lab Organization
GMD: Default Lab

Organization
(B) Find
Select lab organization

Field
User Value
(B) OK
(I) Close Form
LA1
Chemicals
LA2

Page 11

ERES Approval for user: Process
ERES Approval for user: Process
Disclaimer: Please note that the ADS E-Records and Workflow event profile options and
related setup were created as a demonstration solution to allow SCs to quickly enable and
disable the events, and should not be portrayed to prospects as a standard part of the
applications or as an implementation example.
15. Switch Responsibility
Field
Responsibility
Formulator
Chemicals
Formulator
16. Query the Profile Options for Formula/Recipe Workflows and ERES Approval
(N) Others > Profile Options
Query by Example
Field
Profile Name
ADSP%
Chemicals
ADSP%
List of profile options will be displayed.

17. Verify/Enable the Profile Options for Formula/Recipe Workflows and ERES Approval
Verify/Change the User Value for the profile options

Field
Chemicals
Profile Name


User Value
Yes
Yes
Profile Name
ADSP:GMD ERES Recipe Status

Change Approval

User Value
Yes
Yes
Profile Name

Validity Status Change Approval

Validity Status Change
Approval

Page 12
User Value
(I) Save
(I) Close Form
Yes
Yes
If Pre Demo Steps complete, goto task #18. Otherwise, goto task #1.
Begin Demo

Page 13
Start Demo from adsweb

Start Demo from adsweb
18. (H) http://adsweb.oracleads.com
Opens ADSWEB home page
19. (H) ADS Launchpad
Select Machine (LOV)
Select Instance (LOV)
(B) Launch Demo
Opens ADS Launchpad Portal page

Page 14
Create a New Formula

Create a New Formula
Field
Chemicals
Username
process
process
Password
welcome
welcome
Responsibility
Formulator
Formulator
Note
There are regulations regarding

the ratio between the quantity
used to produce a drug during
clinical trials and the full-scale
production quantity (i.e.
commercial production quantity
cannot be more than 5 times the
quantity used to produce product
for clinical trials). The R&D
Formula produces 200 KGM. We
will start with this formula and
scale to 1000 KGM.
N/A
21. Find an existing formula to copy
(N) Formulas
Field
Organization
LA1
Chemicals
LA2
(I) Find
Field
Formula / Version
8301-R&D / 1
Chemicals
3101-R&D / 2
(B) Find
The formula details are displayed. Notice that scaling allowed is checked for this
formula. The default tab is the Products tab, which displays the product(s) for the
formula.
(T) By-products
No by-products are associated with this formula.

Page 15
(T) Ingredients
The ingredient information is displayed.
22. Copy the formula to create a new one
Place the cursor in the top section of the screen (i.e.: click in the formula version field)
(I) New
Click on the green + at the top of the screen to create a new record
(M) Edit > Duplicate > Record Above
Change the name of the formula

Field
Chemicals
Formula

choice>

choice>
Version
1 or unique version
2 or unique version
(I) Save
Notice that the status of the formula is New.
Use the scroll bar at the bottom of the ingredient details to show more ingredient
information
Click on the first ingredient line

Field
Ingredient
8801
Chemicals
3201
Change the quantity for the ingredient line

Field
Quantity
9.9
Chemicals
19
(I) Save
Note: When version control is enabled for formulas, as long as the status of the formula
is New, you can continue to change the details of the formula without creating a new
version.
Close Form

Page 16
Setup Technical Data

Setup Technical Data
23. Setup a Technical Parameter
Technical parameters define the formula properties that must be measured during formula
analysis. In this example, we are showing an existing technical parameter to help streamline
the demonstration.
(N) Technical Data > Technical Parameters
(I) Find
Enter Criteria
Field
Chemicals
Parameter
POTENCY
STRENGTH
Note
A technical parameter for

POTENCY is displayed. Notice
that the data type is Weight%
(percent of total weight) and the
unit of measure is % (percent).
For this type of data type, a valid
range and decimal precision is
defined. For POTENCY the value
can be from 0 to 100 and has a
precision of 4 digits to the right of
the decimal point.
A technical parameter for

STRENGTH is displayed.
Notice that the data type is
Weight% (percent of total
weight) and the unit of measure
is % (percent). Also notice that
it has quality test associated
with it. For this type of data
type, a valid range and decimal
precision is defined. For
STRENGTH the value can be
from 0 to 100 and has a
precision of 9 digits to the right
of the decimal point
(B) Find
Select the list of values for Data Type to see the other types data types for technical
parameters.
Discuss the other data types:
Expressions: Expressions are calculations that can be defined by using other technical
parameters as values.
Specific Gravity: Density is a technical parameter that is seeded for each laboratory
organization. The UOM for density in Vision is Specific Gravity. Specific Gravity is
defined as the ratio between weight and volume, as relative to this same ratio of water at

Page 17
60 degrees F (e.g. the specific gravity of water at 60 degrees F = 1). Density is a

required parameter for all laboratories, as this parameter is used to perform conversions
from mass units of measure to volume units of measure.
Other data types include: Character, Numeric, Validation List, Boolean and Volume%.
(I) Close Form
24. Setup Technical Parameter Sequences (Optional)
(N) Technical Data > Technical Parameter Sequences
(I) Find
Enter Criteria
Field
Organization
LA1
Chemicals
LA2
(B) Find
The technical parameter sequences for the above organization are displayed. The
important thing about these sequences is that any technical parameter that is dependent
on another technical parameter, must be sequenced after the one with which it has a
dependency (i.e. If parameter A is defined as an expression that uses parameter B, then
parameter B must be sequenced such that it is in the list before parameter A). The
technical parameter for Density (Specific Gravity in Vision) must always be the first
one in the list.
(I) Close Form
25. Setup Item Technical Data (Optional)
(N) Technical Data > Item Technical Data
(I) Clear Record
(I) Find - The flashlight icon
Enter Criteria
Field
Organization
LA1
Chemicals
LA2
(B) Find

Page 18
The item technical data for the ingredients within the lab org are displayed. Each
ingredient that is included in a formula is given a value for each of the technical
parameters. These values are then used to perform analysis for the formula.
Values for technical parameters can also be derived from sample results in OPM
Quality Management. To use such values, the user must specify a batch or a lot to be
used during formula analysis and the batch or lot must have a sample and results for a
test that is assigned to a technical parameter.
Close Item Technical Data Form

Page 19
Analyze Formula Using Simulator

Analyze Formula Using Simulator
26. Navigate to Simulator
(N) Simulator
(I) Find
Field
Formula/Version

choice from above>
Chemicals

choice from above>
(B) Find
Field
Note
Chemicals
Formula version created during

this demo is displayed. See the
potency information and material
cost information for the formula.
Formula version created during

this demo is displayed. See the
strength information for the
formula.
27. Show the ability to do "what-if" analysis by changing the quantity for one of the ingredients
Click in the quantity field for the first ingredient
Enter a new value for the ingredient line

Field
Chemicals
Ingredient
8801
3201
Value
10.1
21
(B) Recalculate
Field
Note
See that the cost and potency

totals for the product are now
increased.
Chemicals
See that the strength total for the

product is now increased.
Note that this is only for what-if analysis and does not actually change the formula.
Explain that this screen can be used to show lot-specific values, based on sample
results.
28. Update Formula with Changed Ingredient Value

Page 20
(M) Actions > Update Formula
(B) Yes
(I) Close Form discarding the pending changes.

Page 21
Request Approval for General Use

29. Query Formula
(N) Formulas
(I) Find
Field
Formula/Version

choice from above>
Chemicals

choice from above>
(B) Find
30. Request Approval to Change Formula Status
Select new status

Field
Change Status To
Chemicals
(B) OK
Electronic Signatures is displayed showing the approvals needed.
(B) Submit
(B) Yes and close Electronic Signatures
(B) OK
Status of formula is now Request Approval for General Use
(I) Close Form
31. Logout
(H) Logout

Page 22
Approve Formula Status Change

Field
Chemicals
Username
Process_ops
Process_ops
Password
welcome
welcome
Responsibility
Workflow
Workflow
33. Approve the formula status change
(N) Advanced Worklist
Click on Notification for Formula Status Change Approval

See the details of the formula status change.
Enter the response at the bottom of the page

Field
Chemicals
Signature Type
Reviewer
Reviewer
I have read the e-record
Yes
Yes
(B) Approve
Enter the electronic signature for Sandra Copeland

Field
Chemicals
Username
PROCESS_OPS
PROCESS_OPS
Password
welcome
welcome
(B) Sign
34. Logout
(H) Logout

Page 23
Create a New Formula Version

Create a New Formula Version
Field
Chemicals
Username
process
process
Password
welcome
welcome
Responsibility
Formulator
Formulator
36. Query Formula
(N) Formulas
Field
Organization
PR1
Chemicals
PR1
(I) Find
Field
Chemicals
Formula

choice from above>

choice from above>
Version
One created/approved above
One created/approved above
(B) Find
See that formula status is now Approved for General Use
37. Change the quantity for the first ingredient line
(T) Ingredients
Click on the first ingredient line
(B) Edit Line
Change the quantity for the ingredient line

Field
Quantity
10
Chemicals
20
(I) Save

Page 24
A message appears informing you that a new version will be created. Any changes to
the formula after the status has been changed to Approved for General use will cause
a new version to be created when Formula Version Control is enabled.
(B) OK (B) OK
Notice that the version for the formula has been incremented, and the status of the
formula version is New.
Change organization
Field
Organization
(I) Save
(I) Close Form
PR1
Chemicals
PR1

Page 25
View Formulas in Formulator Workbench

View Formulas in Formulator Workbench
38. Navigate to the Formulator Workbench
(N) Formulator Workbench
39. Explode the Formula element in the hierarchy and scroll down to the formula created above
(I) Formulas
Click on the (+) next to the Formulas element to display the list of formulas and drag the
scroll bar down until the formula is visible
Field
Chemicals
Formula

choice from above>

choice from above>
Version
One just created above
One just created above
Note the status of the formula

40. Explode the formulas and then explode the ingredients
(I) Click on the (+) next to the above Formula
Click on the above formula element to see the Formula Header Summary
Click on the Products element to see the Formula Products Summary
Click on the (+) next to the Products
Click on the product element to see the Product Line Edit Screen
Click on the Ingredients element to see the Formula Ingredients Summary
Click on the (+) next to the Ingredients
Click on the one of the ingredient element to see the Ingredient Line Edit screen
Formulas have properties that must be measured. For this example, the
potency/strength of the formula must be measured. The material cost can also be
measured, if needed.
Close the Formulator Workbench

Page 26
Scale Formula/Version
Scale Formula/Version
41. Scale the formula to meet the full-scale production quantity
(N) Formulas
42. Find the Formula
(I) Find
Field
Formula/Version
(B) Find
(T) Ingredients

choice from above and the one
that is not yet approved>
Chemicals

choice from above and the one
that is not yet approved >
Make a note of the current ingredient quantities
(T) Products
Click in the formula header zone (i.e. Formula field)
(M) Actions > Scale
Enter a percentage to scale the formula

Field
Factor
300
Chemicals
500
Notice that since you started to scale the formula while the cursor was on the formula
header, your only option is to scale by a percentage.
(B) OK
Notice that the product quantity has changed
(T) Ingredients
Notice that the ingredient quantities have change proportionally
(T) Products

Page 27
Click on the product (i.e. product field)
(M) Actions > Scale

Notice that you are now able to scale by the product item quantity
Enter a new quantity for the product line

Field
Chemicals
Item Quantity
Checked
Checked
New Quantity
1000
5000
(B) OK
Notice that the product quantity has again changed.
(T) Ingredients
Notice that the ingredient quantities have again changed proportionally
(I) Save

Page 28

43. Request Approval to Change Formula Status
Select new status

Field
Change Status To
Chemicals
(B) OK
(B) Submit
(B) OK
Status of formula is now Request Approval for General Use
(I) Close Form
44. Logout
(H) Logout

Page 29

Field
Chemicals
Username
Process_ops
Process_ops
Password
welcome
welcome
Responsibility
Workflow
Workflow
46. Approve the formula status change
Click on Notification for Formula Status Change Approval

See the details of the formula status change.

Field
Chemicals
Signature Type
Reviewer
Reviewer
Yes
Yes
(B) Approve

Field
Chemicals
Username
PROCESS_OPS
PROCESS_OPS
Password
Welcome
Welcome
(B) Sign
47. Logout
(H) Logout

Page 30
Create Routing/Version to Accommodate Scaled Formula

Create Routing/Version to Accommodate Scaled Formula
Field
Chemicals
Username
Process
Process
Password
welcome
welcome
Responsibility
Process Engineer
Process Engineer
In this example, the routing and its components have already been aligned with the scaled
formula. This will allow a more streamlined demonstration as you can simply show the
existing data.
49. Create/Modify Routing
(N) Process Routings

Field
Organization
PR1
PR1
(I) Find
Field
Routing
Chemicals
8301-PILOT
Chemicals
3101-PILOT
(B) Find
See that the status of the Routing is Approved for General Use. A new routing can be
entered from scratch via this screen. The same copy functionality exists for this screen
as for the Formula screen, to assist with creation of new routings. As with formulas,
new routing versions can also be created.
50. Create/Modify Operations
Click on the first Operation
(B) Edit Operation

See that the status of the Operation is Approved for General Use. A separate
Operations screen can also be used to create and maintain operations. Operations can
also be version controlled.
Click on the Activity


Page 31
Field
Activity
RUN-TIME
Chemicals
CH-MIX
(B) Edit Activity Line

Activity details can be modified here.
(I) Close Edit Activities
(B) Resources
The default tab is Throughput. See that the throughput is sufficient for the scaled
formula.
(T) Cost Information (Optional)

Review the cost classification and analysis information for the resources
(T) Scheduling Information (Optional)

Review the scheduling information for the resources
(B) Parameters (Optional)

Operation Resource Process Parameters can be entered here
(B) Edit Resource Line

See the detailed resource information. Plant-specific resource information can be
maintained here (in this case the plant is the owner organization for the routing: PR1).
Note that separate screens are also available to create and maintain resource information
at both a generic and plant-specific level.
Close all windows and return to navigator

Page 32
Establish Routing Step-Dependencies using Routing Designer

Establish Routing Step-Dependencies using Routing Designer
51. Navigate to Routing Designer
In this example, we will show an existing routing with step-dependencies that are already
established in order to streamline the demonstration.
(N) Routing Designer

Routing Find Screen Appears
52. Find the Routing
Enter Criteria
Field
Routing
8301-PILOT
(B) Find
(B) Edit
Chemicals
3101-PILOT
53. Review the Routing Information
Click on the (+) icon to explode the routing element

The process instruction sheet is displayed to the right.
Click on the (+) icon to explode the second routing step element
Field
Routing Step Element
GRANULATION
Chemicals
CH-HEATING
Click on the (+) icon to explode the activity element

Field
Activity Element
RUN-TIME
Chemicals
CH-HEAT
Right click on the resource and select Properties

Field
Resource
BLENDER
Chemicals
CH-TANK
Properties for the above resource are displayed.


Page 33
(B) OK
Click on the routing so that it is highlighted

Field
Routing
8301-PILOT
Chemicals
3101-PILOT
(M) Actions > Properties

The properties for the routing are displayed.
(B) Cancel
Click on the routing step so that is highlighted

Field
Routing Step
GRANULATION
Chemicals
CH-HEATING
(M) Actions > Properties

The properties for the routing step are displayed. Notice that the routing step quantity
and release type can be modified here.
54. Review Step-Dependencies
(T) Step Dependency

Incoming Step Dependencies are displayed
Select the Outgoing Steps option

Outgoing Step Dependencies are displayed
(B) Cancel
55. Add/Modify Step Dependencies
(T) Step Dependency Graph

The step dependency graph for the routing is displayed
Drag one of the routing steps to a new position in the graph
Leave the % as the Find criteria for the Operation List
(B) Find

Page 34
List of available Operations is displayed. Explain that the Routing Designer is currently
in Drag mode.
Drag one of the operations to the step-dependency graph

Field
Operation
For example: 1-PACKAGING
Chemicals
For example: CHPACKAGING
Step properties are displayed, allowing the properties to be defined for a new routing
step.
(B) Cancel
(I) Connect Mode

Explain that the Routing Designer is now in Connect Mode
Click and drag from one step to another step

Field
Chemicals
From Step
PHARMACY
CH-MIXING
To Step
QC
CH-QC-2
Step-dependency properties are displayed, allowing the properties to be defined for a

new step-dependency.
(B) Cancel
Show display options (Org-Char, Interleaved, Vertical)
Close all windows without saving the changes and return to navigator

Page 35
Create New Recipe from Approved Formula/Routing/Operation

Create New Recipe from Approved Formula/Routing/Operation
56. Switch responsibility
(I) Switch Responsibility

Field
Responsibility
Formulator
Chemicals
Formulator
As with Formulas and Routings, Recipes can be created and maintained via a forms screen.
However, in this example we will show how to created a new Recipe via a graphical user
interface called the Recipe Designer. Recipes can also be version controlled.
57. Find an existing Recipe
(N) Recipe Designer

Field
Organization
PR1
Chemicals
PR1
Enter Criteria to Find Recipe

Field
Ingredient
8301
Chemicals
3101
Explain the other criteria that can be used to find an existing recipe.
(B) Find
Field
Note
The Recipe for 8201 is displayed.
Chemicals
Recipes for 3001 and 3002 are

displayed.
(B) Edit
Field
Note
Chemicals
The Recipe for 8201 is displayed

in the recipe designer. Notice that
8301 is an ingredient of the
formula for this recipe
The Recipe for 3001 is

displayed in the Recipe
Designer. Notice that 3101 is an
ingredient of the formula for
this recipe
Close the Recipe Designer to return to Find Recipes


Page 36
58. Create a New Recipe
(B) New
Right Click on the NEW Recipe node and select properties

Field
Chemicals
Recipe

choice from above>

choice from above>
Version
1 or unique version
2 or unique version
Description
Recipe for 8301 Pilot
Recipe for 3101 Pilot
(T) Formula
Field
Chemicals
Formula

choice from above>

choice from above>
Version
(T) Routing
Field
Chemicals
Routing
8301-PILOT
3101-PILOT
Version
(B) OK
(I) Save
(I) Click on the (+) icon to explode the recipe and see its details
(T) Step Dependency Graph

Step dependency graph is displayed. See that Routing Designer is also available from
within Recipe Designer.
59. Establish Step-item Dependencies
Click on the (+) icon to explode the first operation node
(T) Ingredients
(N) View Unassigned Items
Drag one of the ingredients to the operation node to create an item step dependency

Page 37
(I) Save
60. Request Change of Status for Recipe
(B) Yes to changes pending note
Select new status

Field
Change Status To
Chemicals
(B) OK
(B) Submit
(B) OK
Status of recipe will now be Request Approval for General Use
Close Recipe Designer
61. Logout
(H) Logout

Page 38
Approve Recipe Status Change

Approve Recipe Status Change
Field
Chemicals
Username
Process_ops
Process_ops
Password
welcome
welcome
Responsibility
Workflow
Workflow
63. Approve the recipe status change
Click on Notification for Recipe Status Change Approval

See the details of the recipe status change.

Field
Chemicals
Signature Type
Reviewer
Reviewer
Yes
Yes
(B) Approve

Field
Chemicals
Username
PROCESS_OPS
PROCESS_OPS
Password
Welcome
Welcome
(B) Sign
64. Logout
(H) Logout

Page 39
Create a Recipe Validity Rule

Create a Recipe Validity Rule
Field
Chemicals
Username
Process
Process
Password
welcome
welcome
Responsibility
Formulator
Formulator
66. Navigate to Recipe Screen and Find Recipe
(N) Recipes
Field
Organization
PR1
Chemicals
PR1
(I) Find
Field
Chemicals
Recipe

choice from above>

choice from above>
Version
1 <One approved above>
2 or <One approved above>
(B) Find
Recipe is displayed. Notice that the status is now Approved for General Use.
67. Create a Recipe Validity Rule
(B) Validity Rules
Enter Organization
Field
Organization
PR1
PR1
(I) Save
68. Request Change of Status for Validity Rule
Chemicals

Page 40
Select new status

Field
Change Status To
Chemicals
(B) OK
(B) Submit
(B) OK
Status of validity is now Request Approval for General Use
Close Forms
69. Logout
(H) Logout

Page 41
Approve Recipe Validity Rule Status Change

Approve Recipe Validity Rule Status Change
Field
Chemicals
Username
Process_ops
Process_ops
Password
welcome
welcome
Responsibility
Formulator
Formulator
71. Approve the recipe validity rule status change
(N) Workflow > Advanced Worklist
Click on Notification for Recipe Validity Status Change Approval

See the details of the recipe status change.

Field
Chemicals
Signature Type
Reviewer
Reviewer
Yes
Yes
(B) Approve

Field
Chemicals
Username
PROCESS_OPS
PROCESS_OPS
Password
Welcome
Welcome
(B) Sign
(H) Home
72. Review the recipe and validity rule to see that the status has changed.
(N) Recipes
Field
Organization
PR1
Chemicals
PR1

Page 42
(I) Find
Field
Chemicals
Recipe

choice from above>

choice from above>
Version
1 <One approved above>
2 or <One approved above>
(B) Find
(B) Validity Rules

See that the validity rule is now Approved for General Use
End of activity.
Demo Support
Please see http://adsweb.oracleads.com > (M) Support > Procedures, for current information
regarding demonstration support.

Page 43
Flowchart
Start
B
Enable Formula
Version Control
Log into Oracle
Applications Portal (1)
Query Organization
Parameters for PR1 (2)
Enable Formula
Version Control for
Organization PR1 (3)
Query Organization
Parameters for Lab
Organization (4)
Enable Formula
Version Control for Lab
Organization (5)
Verify/Enable
Profile Options for
Formula/Recipe
Workflows & ERES
Approval for user:
Process_Ops
Verify/Enable
Profile Options for
Formula/Recipe
Workflows & ERES
Approval for user:
Process_Ops
(6)
Verify Default Lab

Profile
Log into Oracle
Verify Profile (14)
Query Profile Options

for Formula/Recipe
Workflows & ERES
Approval (7)
Verify/Enable Profile
Options for Formula/
Recipe Workflows &
ERES Approval (8)
Verify/Enable
Profile Options for
Formula/Recipe
Workflows & ERES
Approval for user:
Process
(15)
Query Profile Options
for Formula/Recipe
Workflows & ERES
Approval (16)
Verify/Enable Profile
Options for Formula/
Recipe Workflows &
ERES Approval (17)
Create a Pilot
Routing (For
Chemicals Demo
Only)
Find an existing routing
to copy (9)
Copy routing to create a
new one (10)
Approve Routing (11)
Logout (12)

Page 44
Setup Technical
Data
N
Pre Demo
Steps complete?
Request Approval
for General Use
Setup a Technical
Parameter (23)
Setup Technical
Parameter Sequences
(Optional) (24)
Setup Item Technical
Data (Optional) (25)
B
Y
Start Demo from

adsweb
Request Approval to
Change Formula Status
(30)
Logout (31)
Approve Formula
Status Change
(H) http://
adsweb.oracleads.com
(18)
(H) ADS Launchpad
(19)
Analyze Formula
Using Simulator
Navigate to Simulator
(26)
Show ability to do "whatif" analysis by changing
quantity for one of
ingredients (27)
Update Formula with
Changed Ingredient
Value (28)
Create a New
Formula
Log into Oracle
Find an existing formula
to copy (21)
Copy formula to create
a new one (22)
Request Approval
for General Use
Log into Oracle

Approve formula status
change (33)
Logout (34)
Create a New
Formula Version
Log into Oracle
Query Formula (36)
Change quantity for
first ingredient line (37)
C
Query Formula (29)
View Formulas in
Formulator
Workbench
Approve Formula
Status Change
Log into Oracle
Approve formula status
change (46)
Logout (47)
Navigate to Formulator
Workbench (38)
Explode Formula
element in hierarchy &
scroll down to formula
created above (39)
Explode formulas & then
explode ingredients
(40)
Create New Recipe

from Approved
Formula/Routing/
Operation
Log into Oracle

Create/Modify Routing
(49)
Create/Modify
Operations (50)
Scale formula to meet

full-scale production
quantity (41)
Find Formula (42)
Request Approval to
Change Formula Status
(43)
Logout (44)
Find Routing (52)

Review Routing Info
(53)
Review StepDependencies (54)
Add/Modify Step
Dependencies (55)
Create Routing/
Version to
Accommodate
Scaled Formula
Scale Formula/
Version
Request Approval
for General Use
Establish Routing
Step-Dependencies
using Routing
Designer
Switch responsibility
(56)
Find an existing Recipe
(57)
Create a New Recipe
(58)
Establish Step-item
Dependencies (59)
Request Change of
Status for Recipe (60)
Logout (61)
Establish Routing
Step-Dependencies
using Routing
Designer
Navigate to Routing
Designer (51)

Page 45
Approve Recipe
Status Change
Log into Oracle
Approve recipe status
change (63)
Logout (64)
Create a Recipe
Validity Rule
Log into Oracle
Navigate to Recipe
Screen & Find Recipe
(66)
Create a Recipe
Validity Rule (67)
Request Change of
Status for Validity Rule
(68)
Logout (69)
Approve Recipe
Validity Rule
Status Change
Log into Oracle
Approve recipe validity
rule status change (71)
Review recipe & validity
rule to see that status
has changed. (72)
End

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OPM Product Development Concept To Release r12

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Life Sciences - Concept to Release

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release