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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
Copyright © Oracle Corporation, 2003. All rights reserved.
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
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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
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Life Sciences - Concept to ReleasePage 2
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
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Life Sciences - Concept to ReleasePage 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 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)
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Life Sciences - Concept to ReleasePage 4
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
Field Life Sciences-Pharmaceuticals
Chemicals
Organization PR1 PR1
(B) Find
3. Enable Formula Version Control for Organization PR1
(T) Formula
Field Life Sciences-Pharmaceuticals
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
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Life Sciences - Concept to ReleasePage 5
Field Life Sciences-Pharmaceuticals
Chemicals
Organization LA1 LA2
(B) Find
5. Enable Formula Version Control for Lab Organization
(T) Formula
Field Life Sciences-Pharmaceuticals
Chemicals
Version Control Yes Yes
(I) Save, if change made.
(I) Close Form
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Life Sciences - Concept to ReleasePage 6
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
Field Life Sciences-Pharmaceuticals
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
Field Life Sciences-Pharmaceuticals
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
Field Life Sciences-Pharmaceuticals
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
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Life Sciences - Concept to ReleasePage 7
Validity Status Change Approval Validity Status Change Approval
User Value Yes Yes
(I) Save
(I) Close Form
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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
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Life Sciences - Concept to ReleasePage 9
(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
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Life Sciences - Concept to ReleasePage 10
Verify Default Lab Profile
Verify Default Lab Profile
13. Log into Oracle Applications Portal
Field Life Sciences-Pharmaceuticals
Chemicals
Username process process
Password welcome welcome
Responsibility System Administrator System Administrator
14. Verify Profile
(N) Profile > System
Enter search criteria
Field Life Sciences-Pharmaceuticals
Chemicals
User PROCESS PROCESS
Profile GMD: Default Lab Organization GMD: Default Lab Organization
(B) Find
Select lab organization
Field Life Sciences-Pharmaceuticals
Chemicals
User Value LA1 LA2
(B) OK
(I) Close Form
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Life Sciences - Concept to ReleasePage 11
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
Field Life Sciences-Pharmaceuticals
Chemicals
Responsibility Formulator Formulator
16. Query the Profile Options for Formula/Recipe Workflows and ERES Approval
(N) Others > Profile Options
Query by Example
Field Life Sciences-Pharmaceuticals
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
Field Life Sciences-Pharmaceuticals
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
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Life Sciences - Concept to ReleasePage 12
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
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Life Sciences - Concept to ReleasePage 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
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Life Sciences - Concept to ReleasePage 14
Create a New Formula
Create a New Formula
20. Log into Oracle Applications Portal
Field Life Sciences-Pharmaceuticals
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 Life Sciences-Pharmaceuticals
Chemicals
Organization LA1 LA2
(I) Find
Field Life Sciences-Pharmaceuticals
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
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Life Sciences - Concept to ReleasePage 15
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
Field Life Sciences-Pharmaceuticals
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
Field Life Sciences-Pharmaceuticals
Chemicals
Ingredient 8801 3201
Change the quantity for the ingredient line
Field Life Sciences-Pharmaceuticals
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.
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Life Sciences - Concept to ReleasePage 16
Close Form
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Life Sciences - Concept to ReleasePage 17
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 Life Sciences-Pharmaceuticals
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
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Life Sciences - Concept to ReleasePage 18
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
Field Life Sciences-Pharmaceuticals
Chemicals
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
Field Life Sciences-Pharmaceuticals
Chemicals
Organization LA1 LA2
(B) Find
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Life Sciences - Concept to ReleasePage 19
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
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Life Sciences - Concept to ReleasePage 20
Analyze Formula Using Simulator
Analyze Formula Using Simulator
26. Navigate to Simulator
(N) Simulator
(I) Find
Field Life Sciences-Pharmaceuticals
Chemicals
Formula/Version 8301-PILOT <or name of your choice from above>
3101-PILOT <or name of your choice from above>
(B) Find
Field Life Sciences-Pharmaceuticals
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
Field Life Sciences-Pharmaceuticals
Chemicals
Ingredient 8801 3201
Value 10.1 21
(B) Recalculate
Field Life Sciences-Pharmaceuticals
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.
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28. Update Formula with Changed Ingredient Value
(M) Actions > Update Formula
(B) Yes
(I) Close Form discarding the pending changes.
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Life Sciences - Concept to ReleasePage 22
Request Approval for General Use
Request Approval for General Use
29. Query Formula
(N) Formulas
(I) Find
Field Life Sciences-Pharmaceuticals
Chemicals
Formula/Version 8301-PILOT <or name of your choice from above>
3101-PILOT <or name of your choice from above>
(B) Find
30. Request Approval to Change Formula Status
(M) Actions-> Change Status
Select new status
Field Life Sciences-Pharmaceuticals
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
Exit Oracle Applications
(H) Logout
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Life Sciences - Concept to ReleasePage 23
Approve Formula Status Change
Approve Formula Status Change
32. Log into Oracle Applications Portal
Field Life Sciences-Pharmaceuticals
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 Life Sciences-Pharmaceuticals
Chemicals
Signature Type Reviewer Reviewer
I have read the e-record Yes Yes
(B) Approve
Enter the electronic signature for Sandra Copeland
Field Life Sciences-Pharmaceuticals
Chemicals
Username PROCESS_OPS PROCESS_OPS
Password welcome welcome
(B) Sign
34. Logout
(H) Logout
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Life Sciences - Concept to ReleasePage 24
Create a New Formula Version
Create a New Formula Version
35. Log into Oracle Applications Portal
Field Life Sciences-Pharmaceuticals
Chemicals
Username process process
Password welcome welcome
Responsibility Formulator Formulator
36. Query Formula
(N) Formulas
Field Life Sciences-Pharmaceuticals
Chemicals
Organization PR1 PR1
(I) Find
Field Life Sciences-Pharmaceuticals
Chemicals
Formula 8301-PILOT <or name of your choice from above>
3101-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
Field Life Sciences-Pharmaceuticals
Chemicals
Quantity 10 20
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Life Sciences - Concept to ReleasePage 25
(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
Field Life Sciences-Pharmaceuticals
Chemicals
Organization PR1 PR1
(I) Save
(I) Close Form
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Life Sciences - Concept to ReleasePage 26
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 Life Sciences-Pharmaceuticals
Chemicals
Formula 8301-PILOT <or name of your choice from above>
3101-PILOT <or name of your 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
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Life Sciences - Concept to ReleasePage 27
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 Life Sciences-Pharmaceuticals
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
Field Life Sciences-Pharmaceuticals
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
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Life Sciences - Concept to ReleasePage 28
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 Life Sciences-Pharmaceuticals
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
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Life Sciences - Concept to ReleasePage 29
Request Approval for General Use
Request Approval for General Use
43. Request Approval to Change Formula Status
(M) Actions-> Change Status
Select new status
Field Life Sciences-Pharmaceuticals
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
44. Logout
Exit Oracle Applications
(H) Logout
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Life Sciences - Concept to ReleasePage 30
Approve Formula Status Change
Approve Formula Status Change
45. Log into Oracle Applications Portal
Field Life Sciences-Pharmaceuticals
Chemicals
Username Process_ops Process_ops
Password welcome welcome
Responsibility Workflow Workflow
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
Field Life Sciences-Pharmaceuticals
Chemicals
Signature Type Reviewer Reviewer
I have read the e-record Yes Yes
(B) Approve
Enter the electronic signature for Sandra Copeland
Field Life Sciences-Pharmaceuticals
Chemicals
Username PROCESS_OPS PROCESS_OPS
Password Welcome Welcome
(B) Sign
47. Logout
(H) Logout
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Life Sciences - Concept to ReleasePage 31
Create Routing/Version to Accommodate Scaled Formula
Create Routing/Version to Accommodate Scaled Formula
48. Log into Oracle Applications Portal
Field Life Sciences-Pharmaceuticals
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 Life Sciences-Pharmaceuticals
Chemicals
Organization PR1 PR1
(I) Find
Field Life Sciences-Pharmaceuticals
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.
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Life Sciences - Concept to ReleasePage 32
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
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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 Life Sciences-Pharmaceuticals
Chemicals
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
Field Life Sciences-Pharmaceuticals
Chemicals
Routing Step Element GRANULATION CH-HEATING
Click on the (+) icon to explode the activity element
Field Life Sciences-Pharmaceuticals
Chemicals
Activity Element RUN-TIME CH-HEAT
Right click on the resource and select Properties
Field Life Sciences-Pharmaceuticals
Chemicals
Resource BLENDER CH-TANK
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Life Sciences - Concept to ReleasePage 34
Properties for the above resource are displayed.
(B) OK
Click on the routing so that it is highlighted
Field Life Sciences-Pharmaceuticals
Chemicals
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
Field Life Sciences-Pharmaceuticals
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
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Life Sciences - Concept to ReleasePage 35
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 Life Sciences-Pharmaceuticals
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
Field Life Sciences-Pharmaceuticals
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
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Create New Recipe from Approved Formula/Routing/Operation
Create New Recipe from Approved Formula/Routing/Operation
56. Switch responsibility
(I) Switch Responsibility
Field Life Sciences-Pharmaceuticals
Chemicals
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
Field Life Sciences-Pharmaceuticals
Chemicals
Organization PR1 PR1
Enter Criteria to Find Recipe
Field Life Sciences-Pharmaceuticals
Chemicals
Ingredient 8301 3101
Explain the other criteria that can be used to find an existing recipe.
(B) Find
Field Life Sciences-Pharmaceuticals
Chemicals
Note The Recipe for 8201 is displayed. Recipes for 3001 and 3002 are displayed.
(B) Edit
Field Life Sciences-Pharmaceuticals
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
Copyright © Oracle Corporation, 2003. All rights reserved.
Life Sciences - Concept to ReleasePage 37
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
Field Life Sciences-Pharmaceuticals
Chemicals
Recipe 8301-PILOT <or name of your choice from above>
3101-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
Field Life Sciences-Pharmaceuticals
Chemicals
Formula 8301-PILOT <or name of your choice from above>
3101-PILOT <or name of your choice from above>
Version 2 3
(T) Routing
Field Life Sciences-Pharmaceuticals
Chemicals
Routing 8301-PILOT 3101-PILOT
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
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(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
Field Life Sciences-Pharmaceuticals
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 recipe will now be “Request Approval for General Use”
Close Recipe Designer
61. Logout
Exit Oracle Applications
(H) Logout
Copyright © Oracle Corporation, 2003. All rights reserved.
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Approve Recipe Status Change
Approve Recipe Status Change
62. Log into Oracle Applications Portal
Field Life Sciences-Pharmaceuticals
Chemicals
Username Process_ops Process_ops
Password welcome welcome
Responsibility Workflow Workflow
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
Field Life Sciences-Pharmaceuticals
Chemicals
Signature Type Reviewer Reviewer
I have read the e-record Yes Yes
(B) Approve
Enter the electronic signature for Sandra Copeland
Field Life Sciences-Pharmaceuticals
Chemicals
Username PROCESS_OPS PROCESS_OPS
Password Welcome Welcome
(B) Sign
64. Logout
(H) Logout
Copyright © Oracle Corporation, 2003. All rights reserved.
Life Sciences - Concept to ReleasePage 40
Create a Recipe Validity Rule
Create a Recipe Validity Rule
65. Log into Oracle Applications Portal
Field Life Sciences-Pharmaceuticals
Chemicals
Username Process Process
Password welcome welcome
Responsibility Formulator Formulator
66. Navigate to Recipe Screen and Find Recipe
(N) Recipes
Field Life Sciences-Pharmaceuticals
Chemicals
Organization PR1 PR1
(I) Find
Field Life Sciences-Pharmaceuticals
Chemicals
Recipe 8301-PILOT <or name of your choice from above>
3101-PILOT <or name of your 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 Life Sciences-Pharmaceuticals
Chemicals
Organization PR1 PR1
(I) Save
68. Request Change of Status for Validity Rule
Copyright © Oracle Corporation, 2003. All rights reserved.
Life Sciences - Concept to ReleasePage 41
(M) Actions-> Change Status
Select new status
Field Life Sciences-Pharmaceuticals
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 validity is now “Request Approval for General Use”
Close Forms
69. Logout
Exit Oracle Applications
(H) Logout
Copyright © Oracle Corporation, 2003. All rights reserved.
Life Sciences - Concept to ReleasePage 42
Approve Recipe Validity Rule Status Change
Approve Recipe Validity Rule Status Change
70. Log into Oracle Applications Portal
Field Life Sciences-Pharmaceuticals
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.
Enter the response at the bottom of the page
Field Life Sciences-Pharmaceuticals
Chemicals
Signature Type Reviewer Reviewer
I have read the e-record Yes Yes
(B) Approve
Enter the electronic signature for Sandra Copeland
Field Life Sciences-Pharmaceuticals
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 Life Sciences-Pharmaceuticals
Chemicals
Copyright © Oracle Corporation, 2003. All rights reserved.
Life Sciences - Concept to ReleasePage 43
Organization PR1 PR1
(I) Find
Field Life Sciences-Pharmaceuticals
Chemicals
Recipe 8301-PILOT <or name of your choice from above>
3101-PILOT <or name of your 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.
Copyright © Oracle Corporation, 2003. All rights reserved.
Life Sciences - Concept to ReleasePage 44
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)
Verify/EnableProfile Options for
Formula/RecipeWorkflows & ERESApproval for user:
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)
Verify/EnableProfile Options for
Formula/RecipeWorkflows & ERESApproval for user:
Process
Switch Responsibility(15)Query Profile Optionsfor Formula/RecipeWorkflows & ERESApproval (16)Verify/Enable ProfileOptions for Formula/Recipe Workflows &ERES Approval (17)
A
B
Copyright © Oracle Corporation, 2003. All rights reserved.
Life Sciences - Concept to ReleasePage 45
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 Approvalfor General Use
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/Version
Scale formula to meetfull-scale productionquantity (41)Find Formula (42)
Request Approvalfor General Use
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
Copyright © Oracle Corporation, 2003. All rights reserved.
Life Sciences - Concept to ReleasePage 46
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
Copyright © Oracle Corporation, 2003. All rights reserved.
Life Sciences - Concept to ReleasePage 47
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