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Product Lifecycle Management Agile Recipe Management for Pharmaceuticals - Process Management Guide Release 9.3.3 E39302-01 |
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# 2 Working with Projects

A Project tracks all the activities required to successfully complete the making of a product which can either be a molecule or an API or a drug product. Development teams use projects to investigate the processing or manufacturing of a new drug.

You have to define a product in the application before you can begin project planning. A product is the base point for process management in the Agile RMW application. A project targets one or more products, usually variants of the same base molecule to synthesize an API or a drug product for a specific indication. You initiate a project to keep track of all activities related to developing the product.

A Project consists of one or more campaigns. The campaign summary tab of a Project reflects all the activities involved in a project.

## 2.1 Creating a Product

A product is the end result that pharmaceutical companies plan to develop after conducting comprehensive research and selecting a form that is safe to manufacture. It can include target molecules or drug products. A molecule has the potential to treat and cure a disease.

To create a new product:

1. Go to Create New menu, select Processes > Product.

2. In the General tab, enter a unique Product ID.

3. Select Type:

   Drug Formulation - the end product which is examined and analyzed through research and development before moving to the manufacturing stage and eventually marketed.

   Target Molecule - represents the molecule you are examining.

4. Click Finish.

### 2.1.1 Editing Product Details

In the Edit Product page you can only modify the type of the product and the description provided.

To edit product details:

1. Go to Processes > Products and run a search. From the search results, select a product.

2. Click the Edit button.

   The Product ID is unique and cannot be modified.

   To edit product details after you save it with new ID:

3. Go to More > Save As to save the product with a new ID.

4. Enter Product ID and select the Yes button to duplicate all Notes and Attachments of the earlier project.

   To further modify the new product, click Save and Edit.

   To save the new product ID, click OK.

   To return to the search results page, click Cancel.

## 2.2 Product Tabs

The tabs on the Product Details page include:

- General: Details of the type of the product and description of the product.

- Notes and Attachments: Notes/attachments providing additional information.

- History: A detailed account of all events that occurred in the process of creating a product.

- Changes: Records changes that a product undergoes from its initiation.

## 2.3 Creating a Project

Creating projects help you track all the activities related to developing and manufacturing a product.

To create a new project:

1. Go to the Create New menu, select Processes > Project.

2. In the General tab, enter the required information.

   Significant inputs:

   - Project ID - unique identification of the project.

   - Therapeutic Area - clinical condition in which you intend to use the product. For example: Diabetes, Oncology

   - Indication - signs of how the therapeutic area manifests itself or what is apparent to the patient.

3. Click Next.

4. In the Product tab, click Add Row(s) to add a product for which the project is created.

5. Click the Lookup icon. From the search results, select a product.

   Candidate Selection Date - the date on which you select a candidate for the project.

   Project Lifecycle - stage of development.

   § To add more than one product, enter the desired number in the box adjacent to the Add Row(s) button and click Add Row(s).

6. Select a Status - Active, Parked, Terminated.

7. Click Finish.

Note: To set permissions to access the Project, refer to Recipe & Workspace Management Administration Guide.

### 2.3.1 Editing Project Details

You can edit the project details provided the project is in Draft, in Deployment or Parked status and not when it is in the Canceled or the Completed status.

To edit project details:

1. Go to Processes > Project and run a search. From the search results, select a Project.

2. Modify the details you have provided in the General and Product tabs. The Project ID is unique and you cannot modify it.

To edit a project after you save it with new project ID:

1. Click More > Save As to save the Project with a new name and ID.

2. Enter Project ID and select Yes to duplicate all the Notes and Attachments of the earlier project.

   Click Save and Edit to further modify the new project.

   Click OK to save the new project.

   Click Cancel to return to the search results page.

## 2.4 Project Tabs

The tabs on Project Details page include:

- General: Lists details of the Project.

- Product: Lists details of the product associated with it.

- Campaign Summary: Displays all the activities involved in a project. It lays out the actual and planned quantities of the target material at all levels - Campaign, Process Step, Control Recipe and Work Request.

- Notes and Attachments: Notes/attachments providing additional information.

- History

  Status Transition: Lists all the transitions the object undergoes from its initiation.

  Workflows: Lists the statuses a Project workflow.

  Changes: Records changes a Project undergoes from its initiation.

## 2.5 Changing Lifecycle Phases of a Project

A Project goes through the following phases:

- Draft - indicates the initial status of a newly created project.

- In Development - indicates that the project is in use.

- Completed - indicates that the project is completed.

Note: You cannot change a project state to Completed if the associated campaigns are not in Completed or Canceled status.

- Parked - indicates that the project is put on hold and can be taken up again in future. You can also cancel any further work on the parked project.

Note: You cannot park a project if the associated campaigns are not in Completed or Canceled status.

- Canceled - indicates that the project is called off.

To change the lifecycle phase of a project:

1. Go to Processes > Project and run a search. From the search results select a Project.

2. Click Change > Lifecycle Phase and select an appropriate lifecycle phase.

Note: You can change the lifecycle phase of the project to Cancelled or Parked, if the associated campaign, control recipe and work request are in the Completed, Parked, Canceled or Rejected status.

## 2.6 Alerts Associated with a Project

While deploying the RMW application you can set up the following alerts for a project:

Name | Type | Triggered
--- | --- | ---
New Project Alert | Non-mandatory | When you create a new Project and its status is in Development.
Canceled Project Alert | Mandatory | To warn all the associated contacts that the project is canceled.
Parked Project Alert | Mandatory | To warn all the associated contacts that the project is temporarily on hold.

All the alert messages contain details such as Project ID, Project Name, Product, Therapeutic Area, Indication, Candidate Selection Date and Status.