Skip Headers

Agile Product Lifecycle Management Agile Recipe Management for Pharmaceuticals Equipment Management Guide Release 9.3.3 E39300-01 |
| Contents

Previous | Next |

# 3 Qualifying Equipment

Depending on your implementation, you can specify any of the following types of qualification for equipment:

- Installation Qualification - indicates that the installed equipment complies with the manufacturer's specifications.

- Operational Qualification - indicates that equipment performs as intended throughout the anticipated operating ranges.

- Performance Qualification - indicates that equipment and its associated equipment perform effectively based on approved methods and specifications.

Note: The qualification types can be configured and added from Administration > Library > New Record.

Equipment must be qualified at all specified levels of qualification, only then can you reserve it for a process.

When new equipment is added to an equipment category, by default, the qualification status is Pending. The qualification status of equipment is set to Pending if any of the predefined qualification types has an active record with qualification status Expired.

You can change the qualification status from Pending to one of the following qualification states:

- Qualified - When each of the predefined qualification types has an active record with qualification status Qualified.

- Not Qualified - When any of the predefined qualification types has an active record with qualification status Not Qualified.

- Expired - When the qualification state is over upon completion of its qualification duration.

## 3.1 Adding Equipment Qualification

To add a new qualification:

1. Go to Create New menu, select Equipment > Qualification.

2. In the Preface tab, select Equipment ID and click OK.

3. Click Next.

4. In the General tab, enter required information.

   Significant inputs:

   - Qualification Start Date - The date from which the qualification is applicable.

     - If the qualification status is Expired, then the Qualification Start Date should be a past date.

     - If the qualification status is Qualified, then the Start Date should not be a past date.

   - Qualification Duration (in days) - The validity of the qualification status.

     - If the qualification status is Expired, the Qualification Duration should be prior to the current date.

     - If the qualification status is Qualified, the Qualification Duration should not be prior to the current date.

     - This value cannot be negative or zero.

   - Qualification Type - Only the applicable qualifications appear. You can select more than one type.

5. Click Finish.

After you enter qualification information for each qualification type, the qualification status for the equipment changes to Qualified.

## 3.2 Viewing Equipment Qualification Details

To view equipment qualification details:

1. Go to Equipment > Qualification and execute a search to locate the equipment for which you wish to view qualification details.

2. In the search results pane, scroll to the Qualification ID column, and click on the Qualification ID of the equipment.

The Qualification Details page is displayed.