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Agile Product Lifecycle Management Recipe Management for Pharmaceuticals Administrator Guide Release 9.3.3 E39287-01 |
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# 11 Organizations

This chapter provides information about managing companies, sites, locations, departments, and site qualifications in Recipe Management for Pharmaceuticals .

## 11.1 Overview of Organization Management

The Recipe Management for Pharmaceuticals application has four organizational elements, which are interdependent:

- Company

- Department

- Site (and Site Qualification)

- Location

An organization can have multiple companies. Each company can have one or more sites and each site may comprise of one or more locations.

A site is physical location of the company or department. A site cannot exist without company and company cannot be created without having a default site.

A location is a place within a site. For example: room 23, shelf A.

## 11.2 Company Management

A company is the first organizational element. You can have more than one company in an organization. One company is identified as Corporate Company, which owns the application. A company is associated with one or many departments, sites and locations.

### 11.2.1 Creating a Company

Each company has a default site that is the parent site. When you add a company, you have to also add the default site.

You can have more than one company with the same name. Only the company ID has to be unique.

To create a company:

1. In the Create New dropdown menu, select Organizations > Company.

2. In Add Company, you will see the following tabs.

   - General

   - Corporate Site

   - Affiliates

3. In General tab, enter information for the following fields:

   - Name - Enter the name of the company.

   - Description - Enter a brief description about the company.

   - Is Manufacturer - Select Yes, if the company is a manufacturer.

   - Is Supplier - Select Yes, if the company is a supplier.

   - Company Type - Select the company type from the drop-down list.

   - Risk - Select the level of risk from the drop-down list.

4. Click Next.

5. In Corporate Site tab, enter information for the following fields:

   - Site ID - Enter the ID of the site.

   - Site Name - Enter the name of the site.

   - Site Type - Select the type of site from the drop-down list.

   - Address - Enter the address of the site.

   - City - Enter the city of the site.

   - State - Enter the state of the site.

   - Zip code - Enter the zip code of the site.

   - Country - Enter the country of the site.

6. Click Next.

7. In Affiliates tab, click Add Row(s) to enter the details of the vendors that are affiliated to your company. You can add more than one affiliate. To do this, enter the number of affiliates that you want to add in the text box next to Add Row(s) and click Add Row(s). The rows are added to the Affiliates pane. For each row, click the icon to specify the company and select the affiliate relationship from the Affiliate Relationship dropdown.

8. Click Finish. You have added a company and a confirmation message appears.

Note: You can also add new company when you perform a search. In the Results area, click Add to add a new company.

### 11.2.2 Managing Companies

You can search, edit, duplicate, and remove a company, and you can add a site to a company, and manage affiliates for a company.

#### 11.2.2.1 Searching Company

To search for a company:

1. In the Search dropdown menu, select Organizations > Company.

2. In the Search field, enter the "*" wild-card or another value, and click the Execute Search button.

3. In the Results area, on the row of the company you want, click the checkbox and click Edit, or simply double-click the company's link.

#### 11.2.2.2 Editing Company

To edit a company:

1. In the Search dropdown menu, select Organizations > Company.

2. Perform a search for the company.

3. Select the company you want to edit and click Edit.

4. Enter information for the various fields

5. Click OK.

6. Enter the reason for the changes that you have made and click OK. You have edited company details and a confirmation message appears.

#### 11.2.2.3 Duplicating Company

You can create a new instance of an existing company with the same attributes, but with a different name.

To duplicate a company:

1. In the Search dropdown menu, select Organizations > Company.

2. Perform a search for the company.

   Select the company that you want to duplicate and click More > Save As.

3. In the Duplicate Company tab, click Clear.

4. Enter the company name and the site name.

5. Select Notes and Attachments to specify if you want to add notes and attachments.

6. Click Save and Edit to change the associated details or click OK to save the duplicated role without changing the associated details.

   To cancel, click Cancel.

#### 11.2.2.4 Adding Site from Company

To add a site for a company:

1. In the Search dropdown menu, select Organizations > Company.

2. Perform a search for the company.

3. Select the company for which you want to add a site.

4. Click More and select Add Site.

#### 11.2.2.5 Managing Affiliates

You can enter the details of the vendors that are affiliated to your company. You can also add a new company and enter the relationship status of this vendor with your company. To add affiliates to a company, the affiliates must already exist in the system. If not, you must create a company and then proceed to add it as an affiliate.

To manage affiliates:

1. In the Search dropdown menu, select Organizations > Company.

2. Perform a search for the company.

3. Select the company for which you want to manage the affiliates.

4. Click More and select Manage Affiliates.

5. Click New to add an affiliate.

6. In Affiliates, click the look up icon to specify a company as an affiliate.

7. Select the affiliate relationship.

   You can add more than one affiliate. To do this, enter the number of affiliates that you want to add in the text box next to Add Row(s) and click Add Row(s). The rows are added to the Affiliates pane. For each row, click the icon to specify the company and select the affiliate relationship.

8. Click OK.

## 11.3 Site Management

A site is the physical location for a company. A company can have many sites. Sites can have associations with other sites leading to a parent-child relationship. The site name must be unique.

There can be many types of sites such as Enterprise, Area, Process Cell, Unit, Equipment Module, Control Module, Subsidiary, Headquarter, Plant Site, Floor, Building, Lab, Containment Lab, Module, Warehouse and so on.

Sites that have privileges assigned to it are called Privileged sites. While assigning privileges, the user should only select roles for a parent privilege site and not its children. The roles selected for the parent is automatically applied to all its children privilege sites.

Site(s) are mandatory and need to be created while setting up a company.

Sites can be classified depending on its use as:

- Manufacturing - an area where the actual process of creating an API or Intermediate is conducted.

- Storage - define whether the lots stored needs be tracked and stored at a container level.

- Equipment Storage Area - stores equipment such as dryers, reactors, scales and so on.

- Material Storage Area - stores materials.

You can also define whether the Site should follow Clinical Supply (Good Manufacturing Practice).

### 11.3.1 Creating a Site

To add a site, you must first identify a company to which the new site is to be associated. The parent site associated with the company becomes the parent site for this new site.

In addition to specifying the basic site details, you can associate storage types, equipment category and material types with the site. You can do this only if the following conditions are true:

If you select the site as Storage Area, then you can enter the details for the storage area.

If you select the site as Equipment Storage Area or Material Storage Area, then select the appropriate equipment category or the type of material.

To create a site:

1. In the Create New dropdown menu, select Organizations > Site.

2. In the Preface tab, select the parent site to associate this new site.

3. Click Next.

4. In the General tab, enter information for the following fields:

   - Site ID - Enter the site ID.

   - Site Name - Enter the name of the site.

   - Description - Write a brief description about the site.

   - Site Type - Select the type of site.

   - Manufacturing Area - Select Yes, if the site is a manufacturing area.

   - Operating Mode - Select the operating mode from the drop-down list.

   - Environmental Condition - Select the environmental condition from the drop-down list.

   - Has Privilege - Select Yes, if the site has privilege.

   - Is Storage Area - Select Yes, if the site is a storage area.

5. Select Is Storage Area to enable the following:

   - Secured - Select Yes, if the storage area is secured.

   - Quarantine - Select Yes, if the storage area is quarantined.

   - Contains Equipment - Select Yes, if the storage area contains equipment. This selection is a one-time decision and cannot be modified when editing site details

   - Contains Material - Select Yes, if the storage area contains material. This selection is a one-time decision and cannot be modified when editing site details

   - Container Tracking - Select Yes, if the storage area has container tracking.

6. Select Container Tracking based on the following decisions:

   - Select, if you want to track individual containers received in a lot.

   - Do not select, if you want to track only the lot and not the individual containers present in that lot.

   Note: This selection is a one-time decision and cannot be modified when editing site details. Recipe Management for Pharmaceuticals does not recognize those containers that were treated as one lot without container tracking selected, when the lot was received at a site.

7. Click Next.

8. In the Details tab, enter information for the following fields:

   - Address

   - City

   - State

   - Zip code

   - Country

   - If the address is same as the parent site, then select Same as Parent.

9. Click Finish. You have added new site and a confirmation message appears.

### 11.3.2 Managing Sites

You can search, edit, duplicate, and remove sites.

#### 11.3.2.1 Searching Site

To search for a site:

1. In the Search dropdown menu, select Organizations > Site.

2. In the Search field, enter the "*" wild-card or a known name, and click the Execute Search button.

3. In the Results area, on the row of the site you want, click in the checkbox and perform required action.

#### 11.3.2.2 Editing Site

To edit a site:

1. In the Search dropdown menu, select Organizations > Site.

2. Perform a search for the site.

3. Select the site you want to edit and click Edit.

4. Enter information for the various fields.

5. Click OK.

6. Enter the reason for the changes that you have made and click OK. You have edited site details and a confirmation message appears.

#### 11.3.2.3 Duplicating Site

You can create a new instance of an existing site with a different name. If you duplicate a parent site, the children sites are not duplicated.

To duplicate a site:

1. In the Search dropdown menu, select Organizations > Site.

2. Perform a search for the site.

3. Select the site that you want to duplicate and click More > Save As.

4. Specify the Parent Site ID, Site ID, and the Name for the site.

5. Select Notes and Attachments to specify if you want to add notes and attachments.

6. Click Save and Edit to change the associated details or click OK to save the duplicated site without changing the associated details. To cancel, click Cancel.

   You can also duplicate a site from the Browse tab.

#### 11.3.2.4 Removing Site

You can remove a site only if it is not in use and is not associated with users, locations, alerts, or workflows. You can not remove a parent site which is associated with a child site.

To remove a site:

1. In the Search dropdown menu, select Organizations > Site.

2. Perform a search for the site.

3. Select the site that you want to remove.

4. Click Delete. The site is removed.

Note: You can also remove a site from the Browse tab.

#### 11.3.2.5 Moving Site

To move the site to a new location or new parent site:

1. In the Search dropdown menu, select Organizations > Site > Manage.

2. Perform a search for the site.

3. Select the site that you want to move.

4. Click More > Move.

5. Select where you want to move the site and click OK. The site is moved.

Note: You can also move a site from the Browse tab.

## 11.4 Location Management

Location is the actual physical location of a material or equipment within a site.

For example, at a warehouse site called Floor 7, Material X is stored at Bay 4, Row 5, and Column 6.

Every Location has a unique ID. The name of the location need not be unique.

A location belongs to only one site. You cannot move it from one site to another.

### 11.4.1 Creating a Location

To create a location:

1. In the Create New dropdown menu, select Organizations > Location.

2. In the Select Site tab, select the site to which you want to associate the location.

3. Click Next.

4. In the Add Locations tab, click on Add Row(s).

5. Enter the following information:

   - Location ID - Enter the location ID.

   - Name - Enter the location name.

   - Description - Write a brief description about the location.

   - Bay - Enter the bay in which the location is present.

   - Row - Enter the row in which the location is present.

   - Stack - Enter the stack in which the location is present.

   - Height - Enter the height of the location.

   - Column - Enter the column of the location.

   - Is Available - Select the checkbox if the location is available.

     Note: You can add more than one location. To do this, enter the number of locations that you want to add in the text box next to Add Row(s) and click Add Row(s). The rows are added to the Add Locations tab. For each row, enter the location details.

6. Click Finish. The confirmation message appears.

### 11.4.2 Managing Locations

You can view details, edit details, duplicate, and remove locations.

#### 11.4.2.1 Searching Location

To search for a location:

1. In the Search dropdown menu, select Organizations > Location.

2. In the Search field, enter the "*" wild-card or another value, and click the Execute Search button.

3. In the Results area, on the row of the location you want, click the checkbox and click Edit, or simply double-click the location's link.

#### 11.4.2.2 Editing Location

To edit a location:

1. In the Search dropdown menu, select Organizations > Location.

2. Perform a search for the location.

3. Select the location for which you want to edit and click Edit.

4. Enter information for the various fields.

5. Click OK.

6. Enter the reason for the changes that you have made and click OK. You have edited a location and a confirmation message appears.

#### 11.4.2.3 Duplicating Location

You can create a new instance of an existing location with the same attributes, but with a different name.

To duplicate a location:

1. In the Search dropdown menu, select Organizations > Location.

2. Perform a search for the location.

3. Select the location that you want to duplicate and click More > Save As.

4. In the Duplicate Location tab, click Clear.

5. Enter the Location ID.

6. Click Save and Edit to change the associated details or click OK to save the duplicated location without changing the associated details.

   To cancel, click Cancel.

#### 11.4.2.4 Removing Location

To remove a location:

1. In the Search dropdown menu, select Organizations > Location.

2. Perform a search for the location.

3. Select the location that you want to remove and click Delete.

4. Enter the reason for removal and click OK. The location is removed.

## 11.5 Department Management

A company can have many departments. Every department belongs to a parent department. A department can be assigned to many users, but a user cannot have access to more than one department.

To add a department you must associate it with the parent department. If you do not, then the department is associated with the default department.

### 11.5.1 Creating a Department

To create a department:

1. In the Create New dropdown menu, select Organizations > Department.

2. In Department: New, under the General tab, enter information for the following fields:

   - Parent Department ID - Enter the parent department ID.

   - Department ID - Enter the department ID.

   - Name - Enter the name of the department.

   - Description - Write a brief description about the department.

3. Click Finish. You have added a new department and a confirmation message appears.

### 11.5.2 Managing Departments

You can search, edit, duplicate, move, and remove departments.

#### 11.5.2.1 Searching Department

To search for a department:

1. In the Search dropdown menu, select Organizations > Department.

2. In the Search field, enter the "*" wild-card or another value, and click the Execute Search button.

3. In the Results area, on the row of the department you want, click the checkbox and click Edit, or simply double-click the department's link.

#### 11.5.2.2 Editing Department

You can create a new instance of an existing department with a different name and ID. If you duplicate a parent department, the children departments are not duplicated.

To duplicate a department:

1. In the Search dropdown menu, select Organizations > Department > Manage.

2. Perform a search for the department.

3. Select the department that you want to duplicate and click Duplicate.

4. In Duplicate Department click Clear.

5. Enter the Department ID and the Name.

6. Select Notes and Attachments to specify if you want to add notes and attachments.

7. Click Save and Edit to change the associated details, or click OK to save the duplicated department without changing the associated details. You have duplicated the department and a confirmation message appears.

   To cancel, click Cancel.

#### 11.5.2.3 Duplicating Department

You can create a new instance of an existing department with a different name and ID. If you duplicate a parent department, the children departments are not duplicated.

To duplicate a department:

1. In the Search dropdown menu, select Organizations > Department.

2. Perform a search for the department.

3. Select the department that you want to duplicate and click More > Save As.

4. In the Duplicate Department tab, click Clear.

5. Enter the department ID and the name.

6. Select Notes and Attachments to specify if you want to add notes and attachments.

7. Click Save and Edit to change the associated details, or click OK to save the duplicated department without changing the associated details. You have duplicated the department and a confirmation message appears.

   To cancel, click Cancel.

#### 11.5.2.4 Moving Department

To move the department:

1. In the Search dropdown menu, select Organizations > Department.

2. Click the Browse tab.

3. Select the department that you want to move and click Move.

4. Select where you want to move to and click OK.

5. Enter the reason for the change and click OK. You have moved the department and a confirmation message appears.

#### 11.5.2.5 Removing Department

You can remove a department only if it is not in use and is not associated with users or sites. If you remove a parent department, all associated children department are also removed.

To remove a department:

1. In the Search dropdown menu, select Organizations > Department > Manage.

2. Perform a search for the department.

   Results displays a list of departments.

3. Select the department that you want to remove and click Delete.

4. Enter the reason for removal and click OK. You have removed the department and a confirmation message appears.

## 11.6 Site Qualification Management

The following sections describe how to manage a site qualification.

### 11.6.1 Creating a Site Qualification

You can add site qualification for a material designation category or for a specific material.

To create a site qualification:

1. In the Create New dropdown menu, select Organizations > Site Qualification.

2. In the General tab, select the Date of Review and Qualification Ends On date.

3. Select the type of audit. The options are Questionnaire and Onsite Audit.

4. Select the Qualified For option. The default is Material Type.

5. Click Next.

6. Select either Add > Site or Add >Site plus Children.

   - The Site option allows you to add a single site.

   - The Site plus Children option adds a site, as well as any child sites it has.

7. Select the site that you want to add and click OK.

8. Click Next. The Details tab has three subtabs:

   - Material

   - Audit

   - Questionnaire

9. If you have selected the Qualified For option as Material Type, then in the Material subtab, select any or all of the following options:

   - Qualified for API - Select Yes, if the material is qualified for API.

   - Qualified for API Start Custom - Select Yes, if the material is qualified for API start custom.

   - Qualified for API Start Commercial - Select Yes, if the material is qualified for API start commercial.

   - Qualified for Intermediate - Select Yes, if the material is qualified for intermediate.

   - Qualified for Raw for API Starting Material - Select Yes, if the material is qualified for raw API starting material.

   - Qualified for Raw Material - Select Yes, if the material is qualified for raw material.

10. Click Next.

11. If you have selected the Qualified For option as Material Specific, then in the Audit subtab, enter the following details:

    - Date Scheduled - Enter the date scheduled.

    - Date of Onsite Audit - Enter the date of onsite audit.

    - Audit Site - Enter the package site.

    - Audit Package Exists? - Select Yes, if the qualification package is attached.

12. Click Next.

13. In the Questionnaire subtab, enter information for the following:

    - Date Sent- Enter the date the material was sent.

    - Date Received - Enter the date the material is received

    - Questionnaire Package Location Site ID - Enter the package site name.

    - Qualification Package Exists? - Select Yes, if qualification package is attached.

14. Click Finish. You have added a new site qualification and a confirmation message appears.

### 11.6.2 Managing Site Qualifications

To manage site qualifications:

1. In the Search dropdown menu, select Organizations > Site Qualification.

2. Perform a search for the site that requires qualification.

3. Open the site for which you want to add qualification.

4. Click More and select Manage Qualification. Results displays the qualifications for the site. In this pane, you can add, edit, remove and qualify the site qualification for a site.

#### 11.6.2.1 Searching Site Qualification

To search for a site qualification:

1. In the Search dropdown menu, select Organizations > Site Qualification.

2. In the Search field, enter the "*" wild-card or another value, and click the Execute Search button.

3. In the Results area, on the row of the site qualification you want, click the checkbox and click Edit, or simply double-click the site qualification's link.

#### 11.6.2.2 Editing Site Qualification

To edit a site qualification:

1. In the Search dropdown menu, select Organizations > Site Qualification.

2. Perform a search for the site qualification you want to edit.

3. In Results, select the site qualification you want and click Edit.

4. Modify the properties, and click OK.

5. Enter the reason for the changes that you have made and click OK. The site qualification is updated.

#### 11.6.2.3 Removing Qualification

To remove a site qualification:

1. In the Search dropdown menu, select Organizations > Site Qualification.

2. Perform a search for the site qualification you want to remove.

3. n Results, select the site qualification that you want to remove and click Delete.

4. Click OK.

5. Enter the reason for the removal and click OK. The site qualification is removed.