---
# System prepended metadata

title: PQ Dry Run

---

# 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.

![](https://i.imgur.com/CWsPiki.png)


## Step 2

Process: Risk Identification & Assessment

Using the menu bar, navigate to Studies page

![](https://i.imgur.com/9Ddz0qX.png)


Select a Study with active RACT. 

![](https://i.imgur.com/utYw1UN.png)


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.

![](https://i.imgur.com/O2X0XKA.png)


## Step 3 

Process: Risk Identification & Assessment

Using the menu bar, navigate to Studies page.

Select a Study with active RACT. 

![](https://i.imgur.com/utYw1UN.png)

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'

![](https://i.imgur.com/CW9V1Ho.png)



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

![](https://i.imgur.com/MzCJDdq.png)




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

![](https://i.imgur.com/eGBq7g4.png)



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.

![](https://i.imgur.com/cJUNZCr.png)

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**.

![](https://i.imgur.com/3S5khPP.png)


## Step 5

Process: Risk Control 

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

![](https://i.imgur.com/ow0c80R.png)


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

![](https://i.imgur.com/nHeBHhB.png)


## Step 6


Process: Risk Control

Using the menu bar, navigate to Tickets page.

![](https://i.imgur.com/aHeYc02.png)


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. 


![](https://i.imgur.com/TRyCgfS.png)



## Step 7

Process: Risk Reporting

Using the menu bar, navigate to RACT page.

Verify that IQRMP Report for the study can be downloaded.

![](https://i.imgur.com/CR8Ifj0.png)



## Step 8

Process: Risk Identification & Assessment due to Study Amendment

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

![](https://i.imgur.com/X2xsjqr.png)


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

- Critical Processes

![](https://i.imgur.com/mlJqE3Q.png)


- Critical Data

![](https://i.imgur.com/IMv2UbU.png)


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


- Target Number of Patients  

- Vital Timelines  

![](https://i.imgur.com/jSJHRoF.png)


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**

![](https://i.imgur.com/V3u2Ghu.png)

![](https://i.imgur.com/sWxm9qC.png)

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

![](https://i.imgur.com/LckbEEK.png)


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. 

![](https://i.imgur.com/lqXTj0o.png)

> **Changes**

![](https://i.imgur.com/xy6ic6N.png)


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)
)