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 ReleasePage i

Table of Contents

Life Sciences - Concept to Release [EDUM0275] 22-Oct-2004....................................................................iOPM Product Development - Concept to Release.........................................................................................1Enable Formula Version Control....................................................................................................................6Verify/Enable Profile Options for Formula/Recipe Workflows and ERES Approval for user: Process_Ops........................................................................................................................................................................8Create a Pilot Routing (For Chemicals Demo only).......................................................................................10Verify Default Lab Profile..............................................................................................................................12Verify/Enable Profile Options for Formula/Recipe Workflows and ERES Approval for user: Process.......13Start Demo from adsweb................................................................................................................................15Create a New Formula....................................................................................................................................16Setup Technical Data......................................................................................................................................18Analyze Formula Using Simulator.................................................................................................................21Request Approval for General Use.................................................................................................................23Approve Formula Status Change....................................................................................................................24Create a New Formula Version......................................................................................................................25View Formulas in Formulator Workbench.....................................................................................................27Scale Formula/Version...................................................................................................................................28Request Approval for General Use.................................................................................................................30Approve Formula Status Change....................................................................................................................31Create Routing/Version to Accommodate Scaled Formula............................................................................32Establish Routing Step-Dependencies using Routing Designer.....................................................................34Create New Recipe from Approved Formula/Routing/Operation..................................................................37Approve Recipe Status Change......................................................................................................................40Create a Recipe Validity Rule........................................................................................................................41Approve Recipe Validity Rule Status Change................................................................................................43Flowchart........................................................................................................................................................45


Life Sciences - Concept to ReleasePage i

OPM Product Development - Concept to Release

Document Control

Date Owner AppRelease

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

11.5.10r3

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.

Paradigm_effective

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.

PitfallsNone

Assumptions

None


Life Sciences - Concept to ReleasePage 1

Related Business Flows (Optional)

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



http://globalxchange.oraclecorp.com/pls/gxchange/ats_urldeeplink.loadfolder?p_folderid=3481071&p_siteid=1

http://globalxchange.oraclecorp.com/gxchange/page?_pageid=1701,1703&_dad=gxchange&_schema=PHP

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 exclusivity—designed by the U.S. Congress to provide incentives for the development of new drugs—can 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)



Enable Formula Version Control

Enable Formula Version Control

1. Log into Oracle Applications Portal

Field Life Sciences-Pharmaceuticals

Chemicals

Username Process_ops Process_ops

Password Welcome Welcome

Responsibility Product Development Security Manager

Product Development Security Manager

2. Query Organization Parameters for PR1

(N) Organization Parameters

(I) Find

Enter Criteria


Chemicals

Organization PR1 PR1

(B) Find

3. Enable Formula Version Control for Organization PR1

(T) Formula


Chemicals

Version Control Yes Yes

(I) Save, if change made.

(I) Close Form

4. Query Organization Parameters for Lab Organization

(N) Organization Parameters

(I) Find

Enter Criteria




Chemicals

Organization LA1 LA2

(B) Find

5. Enable Formula Version Control for Lab Organization

(T) Formula


Chemicals

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


Chemicals

Responsibility Process Engineer Process Engineer

7. Query the Profile Options for Formula/Recipe Workflows and ERES Approval

(N) Others > Profile Options

Query by Example


Chemicals

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


Chemicals

Profile Name ADSP:GMD ERES Formula Status Change Approval

ADSP:GMD ERES Formula Status Change Approval

User Value Yes Yes

Profile Name ADSP:GMD ERES Recipe Status Change Approval

ADSP:GMD ERES Recipe Status Change Approval

User Value Yes Yes

Profile Name ADSP:GMD ERES Recipe ADSP:GMD ERES Recipe



Validity Status Change Approval 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 3101-PILOT <or name of your choice>

Version 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



Chemicals

Username process process

Password welcome welcome

Responsibility System Administrator System Administrator

14. Verify Profile

(N) Profile > System

Enter search criteria


Chemicals

User PROCESS PROCESS

Profile GMD: Default Lab Organization GMD: Default Lab Organization

(B) Find

Select lab organization


Chemicals

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


Chemicals

Responsibility Formulator Formulator

16. Query the Profile Options for Formula/Recipe Workflows and ERES Approval

(N) Others > Profile Options

Query by Example


Chemicals

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


Chemicals

Profile Name ADSP:GMD ERES Formula Status Change Approval

ADSP:GMD ERES Formula Status Change Approval

User Value Yes Yes

Profile Name ADSP:GMD ERES Recipe Status Change Approval

ADSP:GMD ERES Recipe Status Change Approval

User Value Yes Yes

Profile Name ADSP:GMD ERES Recipe ADSP:GMD ERES Recipe



Validity Status Change Approval Validity Status Change Approval

User Value Yes Yes

(I) Save

(I) Close Form

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



Chemicals




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


Chemicals


(I) Find


Chemicals

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


Chemicals

Formula 8301-PILOT <or name of your choice>

3101-PILOT <or name of your 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


Chemicals

Ingredient 8801 3201

Change the quantity for the ingredient line


Chemicals

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


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 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


Chemicals


(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


Chemicals


(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


Chemicals

Formula/Version 8301-PILOT <or name of your choice from above>

3101-PILOT <or name of your choice from above>

(B) Find


Chemicals

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


Chemicals


Value 10.1 21

(B) Recalculate


Chemicals

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


29. Query Formula

(N) Formulas

(I) Find


Chemicals

Formula/Version 8301-PILOT <or name of your choice from above>


(B) Find

30. Request Approval to Change Formula Status


Select new status


Chemicals

Change Status To Approved for General Use Approved for General Use

(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



Approve Formula Status Change




Chemicals



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


Chemicals

Signature Type Reviewer Reviewer

I have read the e-record Yes Yes

(B) Approve

Enter the electronic signature for Sandra Copeland


Chemicals

Username PROCESS_OPS PROCESS_OPS


(B) Sign

34. Logout

(H) Logout



Create a New Formula Version

Create a New Formula Version



Chemicals




36. Query Formula

(N) Formulas


Chemicals


(I) Find


Chemicals

Formula 8301-PILOT <or name of your 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


Chemicals

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


Chemicals


(I) Save

(I) Close Form



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


Chemicals



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



Scale Formula/Version


41. Scale the formula to meet the full-scale production quantity

(N) Formulas

42. Find the Formula

(I) Find


Chemicals

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


Chemicals

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


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





43. Request Approval to Change Formula Status


Select new status


Chemicals


(B) OK


(B) Submit


(B) OK

Status of formula is now “Request Approval for General Use”

(I) Close Form

44. Logout


(H) Logout







Chemicals




46. Approve the formula status change


Click on Notification for Formula Status Change Approval

See the details of the formula status change.



Chemicals



(B) Approve



Chemicals



(B) Sign

47. Logout

(H) Logout



Create Routing/Version to Accommodate Scaled Formula

Create Routing/Version to Accommodate Scaled Formula



Chemicals

Username Process Process


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


Chemicals


(I) Find


Chemicals

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


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


Chemicals


(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


Chemicals

Routing Step Element GRANULATION CH-HEATING

Click on the (+) icon to explode the activity element


Chemicals

Activity Element RUN-TIME CH-HEAT

Right click on the resource and select Properties


Chemicals

Resource BLENDER CH-TANK



Properties for the above resource are displayed.

(B) OK

Click on the routing so that it is highlighted


Chemicals


(M) Actions > Properties

The properties for the routing are displayed.

(B) Cancel

Click on the routing step so that is highlighted


Chemicals

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


Chemicals

Operation For example: 1-PACKAGING For example: CH-PACKAGING

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


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



Create New Recipe from Approved Formula/Routing/Operation

Create New Recipe from Approved Formula/Routing/Operation

56. Switch responsibility

(I) Switch Responsibility


Chemicals


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


Chemicals


Enter Criteria to Find Recipe


Chemicals


Explain the other criteria that can be used to find an existing recipe.

(B) Find


Chemicals

Note The Recipe for 8201 is displayed. Recipes for 3001 and 3002 are displayed.

(B) Edit


Chemicals

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


Chemicals

Recipe 8301-PILOT <or name of your choice from above>


Version 1 or unique version 2 or unique version

Description Recipe for 8301 Pilot Recipe for 3101 Pilot

(T) Formula


Chemicals



Version 2 3

(T) Routing


Chemicals


Version 1 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


(B) Yes to changes pending note

Select new status


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



Approve Recipe Status Change

Approve Recipe Status Change



Chemicals




63. Approve the recipe status change


Click on Notification for Recipe Status Change Approval

See the details of the recipe status change.



Chemicals



(B) Approve



Chemicals



(B) Sign

64. Logout

(H) Logout



Create a Recipe Validity Rule

Create a Recipe Validity Rule



Chemicals

Username Process Process



66. Navigate to Recipe Screen and Find Recipe

(N) Recipes


Chemicals


(I) Find


Chemicals



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


Chemicals


(I) Save

68. Request Change of Status for Validity Rule




Select new status


Chemicals


(B) OK


(B) Submit


(B) OK

Status of validity is now “Request Approval for General Use”

Close Forms

69. Logout


(H) Logout



Approve Recipe Validity Rule Status Change

Approve Recipe Validity Rule Status Change



Chemicals




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.



Chemicals



(B) Approve



Chemicals



(B) Sign

(H) Home

72. Review the recipe and validity rule to see that the status has changed.

(N) Recipes


Chemicals




(I) Find


Chemicals



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.



Flowchart

Start

Enable FormulaVersion Control

Log into OracleApplications Portal (1)Query OrganizationParameters for PR1 (2)Enable FormulaVersion Control forOrganization PR1 (3)Query OrganizationParameters for LabOrganization (4)Enable FormulaVersion Control for LabOrganization (5)

Verify/EnableProfile Options for

Formula/RecipeWorkflows & ERESApproval for user:

Process_Ops

Switch Responsibility(6)



Process_Ops

Query Profile Optionsfor Formula/RecipeWorkflows & ERESApproval (7)Verify/Enable ProfileOptions for Formula/Recipe Workflows &ERES Approval (8)

Create a PilotRouting (For

Chemicals DemoOnly)

Find an existing routingto copy (9)Copy routing to create anew one (10)Approve Routing (11)Logout (12)

Verify Default LabProfile

Log into OracleApplications Portal (13)Verify Profile (14)



Process

Switch Responsibility(15)Query Profile Optionsfor Formula/RecipeWorkflows & ERESApproval (16)Verify/Enable ProfileOptions for Formula/Recipe Workflows &ERES Approval (17)

A

B



Pre DemoSteps complete?

Start Demo fromadsweb

(H) http://adsweb.oracleads.com(18)(H) ADS Launchpad(19)

Create a NewFormula

Log into OracleApplications Portal (20)Find an existing formulato copy (21)Copy formula to createa new one (22)

Setup TechnicalData

Setup a TechnicalParameter (23)Setup TechnicalParameter Sequences(Optional) (24)Setup Item TechnicalData (Optional) (25)

Analyze FormulaUsing Simulator

Navigate to Simulator(26)Show ability to do "what-if" analysis by changingquantity for one ofingredients (27)Update Formula withChanged IngredientValue (28)

Request Approvalfor General Use

Query Formula (29)


Request Approval toChange Formula Status(30)Logout (31)

Approve FormulaStatus Change

Log into OracleApplications Portal (32)Approve formula statuschange (33)Logout (34)

Create a NewFormula Version

Log into OracleApplications Portal (35)Query Formula (36)Change quantity forfirst ingredient line (37)

B

C

A

Y

N

View Formulas inFormulatorWorkbench

Navigate to FormulatorWorkbench (38)Explode Formulaelement in hierarchy &scroll down to formulacreated above (39)Explode formulas & thenexplode ingredients(40)


Scale formula to meetfull-scale productionquantity (41)Find Formula (42)


Request Approval toChange Formula Status(43)Logout (44)

Approve FormulaStatus Change

Log into OracleApplications Portal (45)Approve formula statuschange (46)Logout (47)

Create Routing/Version to

AccommodateScaled Formula

Log into OracleApplications Portal (48)Create/Modify Routing(49)Create/ModifyOperations (50)

Establish RoutingStep-Dependencies

using RoutingDesigner

Navigate to RoutingDesigner (51)

Establish RoutingStep-Dependencies

using RoutingDesigner

Find Routing (52)Review Routing Info(53)Review Step-Dependencies (54)Add/Modify StepDependencies (55)

Create New Recipefrom Approved

Formula/Routing/Operation

Switch responsibility(56)Find an existing Recipe(57)Create a New Recipe(58)Establish Step-itemDependencies (59)Request Change ofStatus for Recipe (60)Logout (61)

D

C



Approve RecipeStatus Change

Log into OracleApplications Portal (62)Approve recipe statuschange (63)Logout (64)

Create a RecipeValidity Rule

Log into OracleApplications Portal (65)Navigate to RecipeScreen & Find Recipe(66)Create a RecipeValidity Rule (67)Request Change ofStatus for Validity Rule(68)Logout (69)

Approve RecipeValidity Rule

Status Change

Log into OracleApplications Portal (70)Approve recipe validityrule status change (71)Review recipe & validityrule to see that statushas changed. (72)

End

D



6 OPM Product Development - Concept to Release r12

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