V025.01

北京华瑞森科技发展有限公司殷培涛

北京华瑞森科技发展有限公司葛泽民

N/A

北京华瑞森科技发展有限公司金跃玲

北京华瑞森科技发展有限公司秦为民

生产运行部

N/A

质量管理部

1

运营管理部

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安全环保部

N/A

综合管理部

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工程部

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EPC总包项目部

N/A

Role

Name

Date

Signature

Reviewed By

System User

Reviewed By

Quality Assurance

Approved By

System Owner

Version

Date

Performed By

Description

1.0

Last Signature Date of   this Document

Initial release.

OQ_1

The   User Login will appear after a few seconds.

The default User is Admin(RL)   with the Password of 1234.

Circle   One:  Pass / Fail

OQ_2

Change   Password

If you need to change your password,   click on the “Change Password" button and enter your current password and   then your new password. Enter the new password again and if they match, click   “Save & Exit" to save the new password.

Circle   One:  Pass / Fail

OQ_3

Backup   and Restore

Two other functions at the login menu   are to “Backup" and “Restore" the database.

Circle   One:  Pass / Fail

OQ_4

Backup file save directory

C:\Program Files   (x86)\Eurotope\BackupDb

Circle   One:  Pass / Fail

OQ_5

Restore  

C:\Program   files (x86)\Eurotope\BackupDb to load properly. You can store it in a   different location, but to restore it must be in the above folder.

Circle   One:  Pass / Fail

OQ_6

To Uninstall All Software Parts

Before you uninstall the software backup all data   with the data backup shown elsewhere in this manual. To uninstall the   software open the “Settings" App at the lower left corner of the screen with   the “gear" icon.

Circle   One:  Pass / Fail

OQ_7

If   you are not logged in with administrative privileges you will be asked to   provide them.

Circle   One:  Pass / Fail

OQ_8

And   you will be asked to confirm your intentions once again.

Circle   One:  Pass / Fail

OQ_9

When   the software is uninstalled you will be notified.

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OQ_10

User   Interface

After   logging in, the Main Page will appear.

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OQ_11

The   Main Menu is organized in several sections described in detail below.

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OQ_12

New Workflow

Start   and create a new Workflow.

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OQ_13

QuickStart Workflow

QuickStart   is   a simple, no-frills workflow that simply acquires a single lane at the first   tab on the AR-2000 and then evaluates the lane with RaPET Evaluation, with   default evaluation method auto-search which searches for peaks but does not   label them, and as all workflows should, ends with a Message Task.

Circle   One:  Pass / Fail

OQ_14

Start：QuickStart

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OQ_15

FDG   Workflow

FDG   is   another relatively simple but likely commonly used workflow that contains 5   tasks:

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OQ_16

A Job   Task to allow the user to enter a unique job name, or keep the   system-default job name “JYYMMDDHHNNSS" where

YY   = Year

MM   =Month

DD   = Day

HH   = Hour of Start

NN   = Minute of Start

SS   = Second of Star

Circle   One:  Pass / Fail

OQ_17

SystemSuit   Workflow

SystemSuit   is   a very useful and relatively complex workflow that can be used as a System   Suitability Routine. It contains measurement, evaluation and QC on the 3   lanes of the calibration plate that comes with the AR-2000: Normalization,   Linearity, and Resolution. While it does not adjust parameters if the results   do not meet specifications, it provides a useful and detailed report of the   results. The workflow contains 11 tasks:

Circle   One:  Pass / Fail

OQ_18

QuickStart   – Loading, Setup and Running a Workflow

From   the Load Menu, highlight the QuickStart workflow and click on “Load"   to load the workflow.

The   QuickStart workflow is a very simple workflow. It consists of 3 tasks:  

               1. Measurement Task – Acquire   the Chromatogram Data

               2. Evaluation Task – Evaluate   the Chromatogram with RaPET Evaluation

3. Message   Task – Give a simple message to indicate the workflow is complete

Circle   One:  Pass / Fail

OQ_19

First   click on Start edit-mode in the Workflow Mode box at the upper left of   the screen.

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OQ_20

Then   click on the Measurement Task in the Tabbed Workflow Window. The   center of the screen should look like:

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OQ_21

The   Device Configuration has a red exclamation point indicating the device   is not properly configured. Click on Device Configuration.

Circle   One:  Pass / Fail

OQ_22

Add   a new device by clicking on the “+" sign by the “Select device" box in the   center of the screen.

Circle   One:  Pass / Fail

OQ_23

Give   the device a name, as an example for this manual we will call it Loaner.   You may want to give it another name like QC Lab AR or something like that.

Enter   the serial number and if you wish the location of the device, for example QC   Lab. For this QuickStart, uncheck the Calibration and Maintenance checkboxes.   They will be explained in the section Definitions of Device   Configuration Options.

Circle   One:  Pass / Fail

OQ_24

Click   “OK" to complete adding the Instrument and go back to the Measurement Task   window. Next click on “Edit Configuration" at the bottom of the screen to   bring up the Instrument Configuration page.

Circle   One:  Pass / Fail

OQ_25

Enter   the same name as the Device for the Configuration Name, in this   example Loaner. Then via the drop-down menu select the active   communication port that was found during installation earlier in the   document.

Circle   One:  Pass / Fail

OQ_26

When   the connection is made, click on “Save and Exit" to finish the Instrument   Configuration.

Circle   One:  Pass / Fail

OQ_27

Click   “Yes" to save the changes. Then Start run-mode by clicking the icon in   the upper left.

Circle   One:  Pass / Fail

OQ_28

Click   on “Start Job" in the center of the Workflow screen.

Circle   One:  Pass / Fail

OQ_29

The   Runtime screen will appear indicating the status of the system at the   bottom of the window – messages such as INITIALIZING ACQUISITION, MOVING   HEAD, and finally ACQUISITION ACTIVE will appear with the radio chromatogram   plot.

Circle   One:  Pass / Fail

OQ_30

The   Evaluation Task will pause if the Auto close after “Run" box is not   checked. Feel free to play with the Evaluation if you wish, but this   is a simple workflow test, so nothing is needed to be done unless you just   want to play

Circle   One:  Pass / Fail

OQ_31

To   finish the workflow close the Evaluation (upper right X or File>X   Exit and the workflow message will appear indicating the completion of the   workflow.

Circle   One:  Pass / Fail

OQ_32

Workflow complete

Click   “Ok", the workflow completes and the basic report is previewed in the right.

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OQ_33

“View/Print" to display a   complete view of the report, you can click the “Save PDF" button to save it   as a PDF.

Circle   One:  Pass / Fail

OQ_34

Permission allocation and   management

Advanced   Techniques – User Administration

User   Management

Managing   users

Create   new user

Circle   One:  Pass / Fail

OQ_35

Create   new user

This   function is used to create a user administrated by RaPET-Lab. Alternatively a   user managed by Windows can be used. The following sections describe the   administration of users managed by RaPET-Lab.

In   ribbon menu select tab Administration and click item Create User.   A Create User form is shown.

Circle   One:  Pass / Fail

OQ_36

Edit   user

An   existing user can be edited in Edit User dialog. Select ribbon tab Administration   and click item Edit User to open the form.

Circle   One:  Pass / Fail

OQ_37

Managing   groups

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OQ_38

Create   new Groups

In   ribbon menu select tab Administration and click item User   Permissions. The RaPET-Lab User Man-agement form is shown. Groups are   managed inside the tab Groups.

Circle   One:  Pass / Fail

OQ_39

Click   “New Group" to open the Add Group form.

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OQ_40

Enter   a name and a short description of the group in the text boxes. To add users   and permissions to the group click “Assign".

The   dialog Assign Members lists all available users to assign to the group.

Circle   One:  Pass / Fail

OQ_41

Click   “Apply" to assign all selected members.

The   dialog Assign Permissions lists all available permissions of the software.

Circle   One:  Pass / Fail

OQ_42

A   mouse right-click opens a context menu to easy work with the table:

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OQ_43

Select   Item:   the permission of the selected row can be checked.

Select   Category (Administrative): all   permissions of the same category are selected, in this figure   "Administrative".

Unselect   Category:   all permissions of the current category will be unchecked.

Group   Rows by Category:   for better overview over groups the table is grouped by category. Now it is   easier to select permissions by its category:

Circle   One:  Pass / Fail

OQ_44

Click   a group icon to expand or collapse a group.

The   menu item Ungroup Rows switches the table view to the previous table   view.

Edit   existing Groups

For   editing a group open RaPET-Lab User Management form with ribbon tab Administrative   - User Permissions.

Select   a row with a group. The buttons right give access to main edit functions:

Assign   Member:   Assign Member to group form opens.

Set   Permissions:   Set Permissions of group form opens.

Delete   Group:   Click to delete the group. A security check prevents accidental deletion.   This button is disabled if a user is assigned to the group.

Edit   Group:   The Edit Group form opens.

Circle   One:  Pass / Fail

OQ_45

Users,   Groups and Permissions

The   main dialog for managing users, groups and permissions is the RaPET-Lab User   Management form:

Circle   One:  Pass / Fail

OQ_46

Add   User to List

By   clicking this button the from Add User appears.

Circle   One:  Pass / Fail

OQ_47

First   select the User management system.

RaPET-Lab:   User ID, name, password and password expiry time are managed with RaPET-Lab.   After selecting all available users listed in the Select user list.  

Circle   One:  Pass / Fail

OQ_48

Click   “Apply" to add the selected user and close the form. The user is added to the   list of RaPET-Lab users and activated.

Circle   One:  Pass / Fail

OQ_49

Create   new User

Click   to create a new user managed by RaPET-Lab.

Assign   to Group

Select   a user from the list and click this button opens the Groups Selection dialog.  

Circle   One:  Pass / Fail

OQ_50

Deactivate/Activate   User

This   button allows to activate a deactivated or deactivate an activated user.   According to the activation state the button changes its text and function.

A   security check prevents accidental activities.

Circle   One:  Pass / Fail

OQ_51

Remove   User

Click   this button to remove a user from the list. A security check prevents   accidental activities.

Circle   One:  Pass / Fail

OQ_52-1

Edit   User

Click   this button to open the Edit User form.

Circle   One:  Pass / Fail

OQ_52-2

Managing   Groups

The   tab Groups lists all available groups in a table. Select a group row to   manage it.

Circle   One:  Pass / Fail

OQ_53

New   Group

Here   a new group is created. Click to open the appropriate form.

Circle   One:  Pass / Fail

OQ_54

Assign   Member

The   form Assign Members to Group opens.

Circle   One:  Pass / Fail

OQ_55

Set   Permissions

With   this function the permissions of the selected group may be edited.

Circle   One:  Pass / Fail

OQ_56

Select   all permissions of the group and “Apply".

For   work with context menu see here.

Circle   One:  Pass / Fail

OQ_57

Managing   Permissions

The   tab Permissions is used to show all available permissions. The table lists   the permissions with a description and the assigned groups.

Circle   One:  Pass / Fail

OQ_58

The   selected permission can be assigned to a group with “Assign Group".

Circle   One:  Pass / Fail

OQ_59

Exporting   a Workflow into RaPET-Lab/AR

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OQ_60

Clicking   Open Workflow brings up a list of available workflows:

Circle   One:  Pass / Fail

OQ_61

Select   SystemSuit and click “Load" to load the workflow. To export SystemSuit, click   on the Workflow icon in the Ribbon-Tab Menu. Then click the Export Workflow   icon.

Circle   One:  Pass / Fail

OQ_62

A   file Save As pops up for the user to find a place to store the exported   workflow.

Circle   One:  Pass / Fail

OQ_63

After   clicking “Save",

Circle   One:  Pass / Fail

OQ_64

Importing a Workflow into RaPET-Lab/AR

Circle   One:  Pass / Fail

OQ_65

Click   “Open"

Circle   One:  Pass / Fail

OQ_66

Adding   a Comment to a Running Task

Circle   One:  Pass / Fail

OQ_67

Clicking   that icon brings up a Comment Dialogue box where you can add a comment as the   task is running.

Circle   One:  Pass / Fail

OQ_68

Adding   a Comment to a previous Job Report

Circle   One:  Pass / Fail

OQ_69

click   on the “+"

Circle   One:  Pass / Fail

OQ_70

In   the Job Summary to the left.

Circle   One:  Pass / Fail

Print Tester Name:

Test Performed By   (Signature/Date):

Reviewer Evaluation:

Did the script pass or   fail (circle one):       Pass   Fail

Reviewer   Signature/Date:  

Has the   test objective been met?

Yes         No

Have ALL   test steps Passed?  If No, then   refer to the discrepancies identified below.

Yes         No

Have any   unexpected results been resolved?

     NA         Yes         No

Are all   applicable screen captures saved and attached to this protocol?

Yes         No

Are all   applicable printouts labeled appropriately and attached to this protocol?

Yes         No

Comments:

Performed by (sign/date):

Reviewed by (sign/date):

1.        

OQ Screen Captures

2.        

Role

Name

Date

Signature

Reviewed By

Quality   Assurance

Approved By

System   Owner