# PQ Dry Run

## Links

ALM:
https://almbiomarin155.saas.microfocus.com/qcbin/

DEV URL SSO:
https://app-val-portal-we-001.azurewebsites.net/login-saml?domain=biomarin-dev.cyntegrity.com

QA/UAT URL SSO:
https://uat.cyntegrity.com/login-saml?domain=uat.cyntegrity.com

PRODUCTION URL SSO:
https://portal.cyntegrity.com/login-saml?domain=biomarin.cyntegrity.com

***

## Step 1

Login to RBQM system using SSO

Record user name.

Note: User must have Business Administrator role.


## Step 2

Process: Risk Identification & Assessment

Using the menu bar, navigate to Studies page


Select a Study with active RACT.


Verify the Study set up by reviewing the required fields in

- Study Details
- Critical Processes
- Critical Data
- Target Number of Patients
- Vital Timelines
- RACT Risk Assessment

Attach IQRMP report.

[IQRMP Report_20220302T172623_062Z](https://bmrn-my.sharepoint.com/:x:/p/ma904058/EWA28U21nBhGgf6tCVhRaX8Blkg886tqkIWKaoCA-T3JRg?e=FcjxDA)

Attach screenshots of Study details, Target Number of Patients, Vital Timelines as evidence.


## Step 3

Process: Risk Identification & Assessment

Using the menu bar, navigate to Studies page.

Select a Study with active RACT.


Verify that the study level risks can be assessed by opening the RACT, update the assessments in the working document, and release the RACT.

> **I clicked on 'Edit working draft'


> **I enabled the question, "Did the switch from IV to oral formulation work properly?"**


> **Then disabled it with the same justification, "No oral formulation available"**


Verify that IQRMP (Integrated Quality Risk Management Plan) can be generated.

> **Where do I verify this?**

> **I now see the 'Release Draft' option **

## Step 4

Process: Risk Identification & Assessment

Using the menu bar, navigate to Risks page.


Verify that risks mitigation action(s) can be created and a KRI can be associated to the risk.

> **I see the ability to create risk mitigation actions**.


## Step 5

Process: Risk Control

Using the menu bar, navigate to KRIs|QTLs page.


Verify that risks can be overseen by selecting one of the KRIs and seeing its ""Details and Comparison"" section.


## Step 6

Process: Risk Control

Using the menu bar, navigate to Tickets page.


For a KRI that needs an escalation, verify that tickets can be generated or reassigned. Verify that corrective and preventive action(s) can be created and managed for the ticket.


## Step 7

Process: Risk Reporting

Using the menu bar, navigate to RACT page.

Verify that IQRMP Report for the study can be downloaded.


## Step 8

Process: Risk Identification & Assessment due to Study Amendment

Using the menu bar, navigate to Studies page. Select a Study with active RACT.


Navigate to Study Details page. Verify that Study set up is modify-able by editing the required fields in

- Critical Processes


- Critical Data


Navigate to Study Settings page. Verify that Study settings are modify-able by editing

- Target Number of Patients

- Vital Timelines


Verify that IQRMP Report displays the updated Critical Processes & Data updates.

Verify that Audit trail displays the changes made to Target Number of Patients and Vital Timelines

> **CHANGES**



> **Changed from 2021-09-20**


Attach IQRMP & Audit trail report as evidence.

[Audit_trail_2022_03_02]([Audit\_trail\_2022\_03\_02.xlsx](https://bmrn-my.sharepoint.com/:x:/p/ma904058/EVfNBG6vs9ZLq_VjKpqbD_IB4ajCFOjzbiNp-GUdsYKfCw?e=UgtF6d)
)

[IQRMP Report_20220302T175404_239Z]([IQRMP Report\_20220302T175404\_239Z.xlsx](https://bmrn-my.sharepoint.com/:x:/p/ma904058/EQXQLpHuYWFNie5B6u4h3vIBYium_5xAlgXYIA471LXGtQ?e=0wQb2G)
)

## Step 9

Process: Risk Control

Using the menu bar, navigate to Tools > Study Settings > Configure

Verify that KRI thresholds can be modified.


> **Changes**


Download the Audit trail report as evidence.

[Audit_trail_2022_03_02]([Audit\_trail\_2022\_03\_02.xlsx](https://bmrn-my.sharepoint.com/:x:/p/ma904058/EVfNBG6vs9ZLq_VjKpqbD_IB4ajCFOjzbiNp-GUdsYKfCw?e=zKCfjz)
)