---
# System prepended metadata

title: UAT Cyntegrity Notes

---

# UAT Cyntegrity Notes

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

RBQM_PQ (excel file on sharepoint)

`https://bmrn.sharepoint.com/:x:/r/teams/GCD_RBMP/Shared Documents/RBM Platform Implementation/7. SDLC Drafts and Finals/3. Test Plans and Scripts/Performance Qualification/RBQM_PQ.xlsx?d=wf26ad846442c475a99e13da1596e4a8d&csf=1&web=1&e=cgJZpP`

## Description (Design Steps)

### Step 1 

Login to RBQM system using SSO 

Record user name.

Note: User must have Business Administrator role.

### Expected 


- [x] User profile information

![](https://i.imgur.com/d6AGkA5.png)

![](https://i.imgur.com/OxYXZH4.png)


### Step 2 

Process: Risk Identification & Assessment

Using the menu bar, navigate to Studies page 

Select a Study with active RACT. 

![](https://i.imgur.com/Docx4wd.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


***

- [x] Study details  

![](https://i.imgur.com/FENyU4x.png)

- [x] Critical Processes  

![](https://i.imgur.com/OW4sTUB.png)

- [x] Critical Data  

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

- [x] Target Number of Patients  

![](https://i.imgur.com/KtYzT4M.png)


- [x] Vital Timelines  

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


- [x] RACT Risk Assessment  

Click on 'Download IQRMP Report' in RACT

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


- [x] Report at link below:

- [Attached IQRMP report](https://bmrn-my.sharepoint.com/:x:/p/ma904058/EbNBDR_oZr9NvX-Vv0PqG4EBR5I35MvnevLwWgOkGvhTUQ?e=lhzlXT). 
Attach screenshots of Study details, Target Number of Patients, Vital Timelines as evidence.


### Expected 

- [x] Study ID - Study Name: 

- [x] Study related information were set up correctly.

- [x] Evidence attached.

### 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.

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

Attach evidence.

- [x] Studies page  

![](https://i.imgur.com/FI3a66E.png)


- [x] Navigate to active RACT  

I chose Study 165-306 

![](https://i.imgur.com/TcIs2dH.png)


- [x] Verify study level risks  

The risks are shown below, 

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


On the Risks tab, I can see the risks grouped by category: 

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


- [x] Update assessments in working document  

  - [x] It can be achieved by selecting/click ‘RACT’ button on a Study >  selecting /click ‘Continue Editing’ button

![](https://i.imgur.com/5uy693q.png)


  - [x] Release the Draft after making some changes to the RACT 

I enabled the question, "Per the Medical Monitor confirm what is the safety risk to the subject?"


![](https://i.imgur.com/A5QxPMs.png)


- [x] Release the RACT  

At the top of the screen (in red) I clicked on 'Relsease Draft'

![](https://i.imgur.com/gICnLT1.png)

Enter a reason 

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


- [x] Verify IQRMP  

The new downloaded IQRMP is [here](https://bmrn-my.sharepoint.com/:x:/p/ma904058/ERql9D8dFKNIjr0hNbiJHtQBsB8EaYSXy3qCgoW1NblhIA?e=CLYRIm)

### Expected 

- [x] Study ID - Study Name: 

- [x] IQRMP was generated.

- [x] Evidence attached.

![](https://i.imgur.com/s0nMhMF.png)


### 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.

- [x] Risks Page  

![](https://i.imgur.com/MwCz9GO.png)


- [x] Risk mitigation action(s) created  

I accepted the risk for RISK_SAF2 (under reporting AEs)

![](https://i.imgur.com/fV2GbrR.png)

In this example, I created a new mitigation 

![](https://i.imgur.com/vfdbQ1w.png)

- [x] KRI associated to the risk  

![](https://i.imgur.com/IIF59sH.png)

Then I have an option to activate the new mitigation: 

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

![](https://i.imgur.com/ADcj9TR.png)




Attach evidence.


### Expected 

- Mitigation action was created for the risk

- Risk Name: 

- Mitigation Action ID: 

![](https://i.imgur.com/20KN2jw.png)


- Evidence attached


### 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.

Attach evidence."

### Expected 

"Risks can be overseen and thresholds are set.

Evidence attached."


### 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. 

Attach evidence."


### Expected 

"KRI(s) were reviewed and performance of the KRI was escalated as a ticket.

Ticket ID: 

Evidence attached."

### Step 7 

"Process: Risk Reporting

Using the menu bar, navigate to RACT page.

Verify that IQRMP Report for the study can be downloaded.

Attach evidence."

### Expected 

"IQRMP report for the study was downloaded.

Evidence attached."

### 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

Attach IQRMP & Audit trail report as evidence. "


### Expected 

"Study ID - Study Name: 

IQRMP report and Audit trail displayed the changes made to the Study. 

Evidence attached."

### Step 9 

"Process: Risk Control 

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

Verify that KRI thresholds can be modified. 

Download the Audit trail report as evidence. "


#### Expected 

"Study ID - Study Name: 

Audit trail report displayed the changes made to the Study. 

Evidence attached."