6 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 Page i
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
Life Sciences - Concept to Release Page i
OPM Product Development - Concept to Release

Document Control
Date 12-Dec-2003 13-Dec-2003 22-Oct-2004 Owner Bruce.Johnson Premanand Bhat Madhavi Dharmadhikari App Release 11.5.9r2 11.5.9r2 11.5.10 Version v1.0 v1.0 V1.1 Change Reference New Document Script Reviewed and Improvements suggested 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. Enhanced for changes due to inventory convergence in R12.
25-Mar-2007
Madhavi Dharmadhikari
12.0
v1.0
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)

Life Sciences - Concept to Release 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
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
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 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Candidate drug Research and development Clinical trials Pilot Scale-up Launch Process/product improvement Line extensions Patent expiry Defense against generics Retirement from marketplace Activity Stage DEVELOPMENT DEVELOPMENT DEVELOPMENT ROLL-OUT ROLL-OUT ROLL-OUT MATURITY MATURITY MATURITY DEFENSE 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)

Enable Formula Version Control Enable Formula Version Control

1. Log into Oracle Applications Portal
Field Life Sciences-Pharmaceuticals Chemicals
Username Password Responsibility
Process_ops Welcome Product Development Security Manager
Process_ops Welcome Product Development Security Manager
2.
Query Organization Parameters for PR1 (N) Organization Parameters (I) Find Enter Criteria
Organization
PR1
PR1
3.
(B) Find
Enable Formula Version Control for Organization PR1 (T) Formula

Version Control
Yes
Yes
4.
(I) Save, if change made. (I) Close Form
Query Organization Parameters for Lab Organization (N) Organization Parameters (I) Find Enter Criteria
Field Life Sciences-Pharmaceuticals
Chemicals
Organization
LA1
LA2
5.
(B) Find
Enable Formula Version Control for Lab Organization (T) Formula

Version Control
Yes
Yes
(I) Save, if change made. (I) Close Form
Verify/Enable Profile Options for Formula/Recipe Workflows and ERES Approval for user: Process_Ops Verify/Enable Profile Options for Formula/Recipe Workflows and 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
Responsibility
Process Engineer
Process Engineer
7.
Query the Profile Options for Formula/Recipe Workflows and ERES Approval (N) Others > Profile Options Query by Example
Profile Name
ADSP%
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
Profile Name User Value Profile Name User Value Profile Name
ADSP:GMD ERES Formula Status Change Approval Yes ADSP:GMD ERES Recipe Status Change Approval Yes ADSP:GMD ERES Recipe Validity Status Change Approval
User Value
Yes
Yes
(I) Save (I) Close Form
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 Chemicals
Organization
PR1
(I) Find
Field Chemicals
Routing / Version
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 Version
3101-PILOT <or name of your choice> 1 or unique version
(I) Save Notice that the status of the routing is New.

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
Verify Default Lab Profile Verify Default Lab Profile

process welcome System Administrator
process welcome System Administrator
14. Verify Profile (N) Profile > System Enter search criteria
User Profile
PROCESS GMD: Default Lab Organization
PROCESS GMD: Default Lab Organization
(B) Find Select lab organization

User Value
LA1
LA2
(B) OK (I) Close Form
Verify/Enable Profile Options for Formula/Recipe Workflows and ERES Approval for user: Process Verify/Enable Profile Options for Formula/Recipe Workflows and 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
Responsibility
Formulator
Formulator
16. Query the Profile Options for Formula/Recipe Workflows and ERES Approval (N) Others > Profile Options Query by Example
Profile Name
ADSP%
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
Profile Name User Value Profile Name User Value Profile Name
User Value
Yes
Yes
If Pre Demo Steps complete, goto task #18. Otherwise, goto task #1.
Begin Demo
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
Create a New Formula Create a New Formula

Username Password Responsibility Note
process welcome Formulator 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.
process welcome Formulator N/A
21. Find an existing formula to copy (N) Formulas

Organization
LA1
LA2
(I) Find
Formula / Version
8301-R&D / 1
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.

(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
Formula 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
Ingredient
8801
3201
Change the quantity for the ingredient line

Quantity
9.9
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
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
Parameter Note
POTENCY 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.
STRENGTH 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
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
Organization
LA1
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
Organization
LA1
LA2
(B) Find
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
Analyze Formula Using Simulator Analyze Formula Using Simulator

26. Navigate to Simulator (N) Simulator (I) Find
Formula/Version
8301-PILOT <or name of your choice from above>
(B) Find
Note
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
Ingredient Value
8801 10.1
3201 21
(B) Recalculate
Note
See that the cost and potency totals for the product are now increased.
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
(M) Actions > Update Formula (B) Yes (I) Close Form discarding the pending changes.
Request Approval for General Use Request Approval for General Use
29. Query Formula (N) Formulas (I) Find
Formula/Version
(B) Find
30. Request Approval to Change Formula Status (M) Actions-> Change Status Select new status
Change Status To
(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
Approve Formula Status Change Approve Formula Status Change

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

Username Password
PROCESS_OPS welcome
PROCESS_OPS welcome
(B) Sign
34. Logout (H) Logout
Create a New Formula Version Create a New Formula Version

process welcome Formulator
process welcome Formulator
36. Query Formula (N) Formulas

Organization
PR1
PR1
(I) Find
Formula Version
8301-PILOT <or name of your choice from above> One created/approved above
3101-PILOT <or name of your choice from 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
Quantity
10
20
(I) Save
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
Organization
PR1
PR1
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
Formula Version
8301-PILOT <or name of your choice from above> One just created above
3101-PILOT <or name of your choice from 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
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

Formula/Version
8301-PILOT <or name of your choice from above and the one that is not yet approved>
3101-PILOT <or name of your choice from above and the one that is not yet approved >
(B) Find (T) Ingredients 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
Factor
300
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
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

Item Quantity New Quantity
Checked 1000
Checked 5000
(B) OK Notice that the product quantity has again changed.
(T) Ingredients Notice that the ingredient quantities have again changed proportionally
(I) Save
Request Approval for General Use Request Approval for General Use
43. Request Approval to Change Formula Status (M) Actions-> Change Status Select new status
Change Status To
(B) Submit (B) Yes and close Electronic Signatures (B) OK Status of formula is now Request Approval for General Use
(I) Close Form
Approve Formula Status Change Approve Formula Status Change

46. 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
Reviewer Yes
Reviewer Yes

Username Password
PROCESS_OPS Welcome
PROCESS_OPS Welcome
(B) Sign
Create Routing/Version to Accommodate Scaled Formula Create Routing/Version to Accommodate Scaled Formula
Process welcome Process Engineer
Process welcome 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
Organization
PR1
PR1
(I) Find
Routing
8301-PILOT
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
Field
Life Sciences-Pharmaceuticals
Chemicals
Activity
RUN-TIME
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
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
Routing
8301-PILOT
3101-PILOT
(B) Find (B) Edit
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
Routing Step Element
GRANULATION
CH-HEATING
Click on the (+) icon to explode the activity element

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

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

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

Routing
8301-PILOT
3101-PILOT
(M) Actions > Properties The properties for the routing are displayed.
(B) Cancel Click on the routing step so that is highlighted

Routing Step
GRANULATION
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
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
Operation
For example: 1-PACKAGING
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
From Step To Step
PHARMACY QC
CH-MIXING 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
Create New Recipe from Approved Formula/Routing/Operation Create New Recipe from Approved Formula/Routing/Operation
56. Switch responsibility (I) Switch Responsibility
Responsibility
Formulator
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
Organization
PR1
PR1
Enter Criteria to Find Recipe

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

58. Create a New Recipe (B) New Right Click on the NEW Recipe node and select properties
Recipe Version Description
8301-PILOT <or name of your choice from above> 1 or unique version Recipe for 8301 Pilot
3101-PILOT <or name of your choice from above> 2 or unique version Recipe for 3101 Pilot
(T) Formula
Formula Version
8301-PILOT <or name of your choice from above> 2
3101-PILOT <or name of your choice from above> 3
(T) Routing
Routing Version
8301-PILOT 1
3101-PILOT 1
(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
(I) Save
60. Request Change of Status for Recipe (M) Actions-> Change Status (B) Yes to changes pending note Select new status
Change Status To
(B) Submit (B) Yes and close Electronic Signatures (B) OK Status of recipe will now be Request Approval for General Use
Close Recipe Designer
Approve Recipe Status Change Approve Recipe Status Change

63. Approve the recipe status change (N) Advanced Worklist Click on Notification for Recipe Status Change Approval See the details of the recipe status change. Enter the response at the bottom of the page
Reviewer Yes
Reviewer Yes

Username Password
PROCESS_OPS Welcome
PROCESS_OPS Welcome
(B) Sign
Create a Recipe Validity Rule Create a Recipe Validity Rule

Process welcome Formulator
Process welcome Formulator
66. Navigate to Recipe Screen and Find Recipe (N) Recipes

Organization
PR1
PR1
(I) Find
Recipe Version
8301-PILOT <or name of your choice from above> 1 <One approved above>
3101-PILOT <or name of your choice from 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
Organization
PR1
PR1
(I) Save
68. Request Change of Status for Validity Rule (M) Actions-> Change Status
Select new status

Change Status To
(B) OK Electronic Signatures is displayed showing the approvals needed. (B) Submit (B) Yes and close Electronic Signatures (B) OK Status of validity is now Request Approval for General Use
Close Forms
Approve Recipe Validity Rule Status Change Approve Recipe Validity Rule Status Change
Process_ops welcome Formulator
Process_ops welcome 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. Enter the response at the bottom of the page
Reviewer Yes
Reviewer Yes

Username Password
PROCESS_OPS Welcome
PROCESS_OPS Welcome
(B) Sign (H) Home
72. Review the recipe and validity rule to see that the status has changed. (N) Recipes
Organization
PR1
PR1
(I) Find
Recipe Version
8301-PILOT <or name of your choice from above> 1 <One approved above>
3101-PILOT <or name of your choice from 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.
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
Query Profile Options for Formula/Recipe Workflows & ERES Approval (7) Verify/Enable Profile Options for Formula/ Recipe Workflows & ERES Approval (8)
Verify Default Lab Profile

Log into Oracle Applications Portal (13) Verify Profile (14)
Verify/Enable Profile Options for Formula/Recipe Workflows & ERES Approval for user: Process
Switch Responsibility (15) Query Profile Options for Formula/Recipe Workflows & ERES Approval (16) Verify/Enable Profile Options for Formula/ Recipe Workflows & ERES Approval (17) A
Verify/Enable Profile Options for Formula/Recipe Workflows & ERES Approval for user: Process_Ops
Switch Responsibility (6)
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)
Setup Technical Data

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

Request Approval to Change Formula Status (30) Logout (31)
Start Demo from adsweb

(H) http:// adsweb.oracleads.com (18) (H) ADS Launchpad (19)
Approve Formula Status Change 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) Log into Oracle Applications Portal (32) Approve formula status change (33) Logout (34)
Create a New Formula

Log into Oracle Applications Portal (20) Find an existing formula to copy (21) Copy formula to create a new one (22)
Create a New Formula Version

Log into Oracle Applications Portal (35) Query Formula (36) Change quantity for first ingredient line (37) C

Query Formula (29)
View Formulas in Formulator Workbench

Navigate to Formulator Workbench (38) Explode Formula element in hierarchy & scroll down to formula created above (39) Explode formulas & then explode ingredients (40)
Approve Formula Status Change

Log into Oracle Applications Portal (45) Approve formula status change (46) Logout (47)
Establish Routing Step-Dependencies using Routing Designer

Find Routing (52) Review Routing Info (53) Review StepDependencies (54) Add/Modify Step Dependencies (55)
Create Routing/ Version to Accommodate Scaled Formula

Log into Oracle Applications Portal (48) Create/Modify Routing (49) Create/Modify Operations (50)
Scale Formula/ Version

Scale formula to meet full-scale production quantity (41) Find Formula (42)
Create New Recipe from Approved Formula/Routing/ Operation

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) D

Request Approval to Change Formula Status (43) Logout (44)
Establish Routing Step-Dependencies using Routing Designer

Navigate to Routing Designer (51)
Approve Recipe Status Change

Log into Oracle Applications Portal (62) Approve recipe status change (63) Logout (64)
Approve Recipe Validity Rule Status Change

Log into Oracle Applications Portal (70) Approve recipe validity rule status change (71) Review recipe & validity rule to see that status has changed. (72)
Create a Recipe Validity Rule

Log into Oracle Applications Portal (65) Navigate to Recipe Screen & Find Recipe (66) Create a Recipe Validity Rule (67) Request Change of Status for Validity Rule (68) Logout (69)
End

6 OPM Product Development - Concept To Release r12

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OPM Product Development Concept to Release

Demo Script (Internal)

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page i

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page i

OPM Product Development - Concept to Release

Related Business Flows (Optional)

Life Sciences - Concept to Release Page 1

Demo Background (For Life Sciences)

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page 2

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page 3

Pre Demo Steps (Optional)

Life Sciences - Concept to Release Page 4

Enable Formula Version Control Enable Formula Version Control

Username Password Responsibility

Process_ops Welcome Product Development Security Manager

Process_ops Welcome Product Development Security Manager

Enable Formula Version Control for Organization PR1 (T) Formula

(I) Save, if change made. (I) Close Form

Life Sciences - Concept to Release Page 5

Enable Formula Version Control for Lab Organization (T) Formula

(I) Save, if change made. (I) Close Form

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page 6

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page 7

(I) Save (I) Close Form

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page 8

(B) Find The routing details are displayed.

3101-PILOT <or name of your choice> 1 or unique version

(I) Save Notice that the status of the routing is New.

Life Sciences - Concept to Release Page 9

Approved for General Use

(B) OK Routing status changes to "Approved for General Use".

(I) Close Form

12. Logout Exit Oracle Applications (H) Logout

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page 10

Verify Default Lab Profile Verify Default Lab Profile

Username Password Responsibility

process welcome System Administrator

process welcome System Administrator

PROCESS GMD: Default Lab Organization

PROCESS GMD: Default Lab Organization

(B) Find Select lab organization

(B) OK (I) Close Form

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page 11

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page 12

(I) Save (I) Close Form

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page 13

Start Demo from adsweb Start Demo from adsweb

Opens ADS Launchpad Portal page

Copyright Oracle Corporation, 2003. All rights reserved.

Life Sciences - Concept to Release Page 14

Create a New Formula Create a New Formula