2023-10-20 ChromSword 5.5 Task

ChromSword Version that is compliant with FDA 21 CFR PART 11 regulations.

Client-server must contain

Logs / Audit trail
Users / Roles
Files clones/backups of originals

Client-server will be able to export all necessary data required by FDA part 11

User management will provide Locked RPTX files that will be operable only with a connection Client Server

All actions with ChromSword Auto and RPTX files will be electronically signed in accordance with FDA part 11

21 CFR PART 11 COMPLIANCE ASSESSMENT - http://www.ecfr.gov/cgi-bin/text-idx?SID=5bae37807e1cbe352a4411be36b88371&mc=true&node=pt21.1.11&rgn=div5

Password strength: https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm091108.htm

Git repos

AdminConsole: https://bitbucket.org/evaldsurtans/git-bitbucket.org-evaldsurtans-chromsword5-1-admin-console

ReportService: https://bitbucket.org/evaldsurtans/chromsword5-5-report-service

ClientServer Service: https://bitbucket.org/evaldsurtans/chromsword5-1-client-server-nodejs

InnoSetup installer (for NodeJS services and WPF apps) https://bitbucket.org/evaldsurtans/chromsword5-5-installer

Schema of how it operates

RPTX files are saved in ClientServer (it can be located on the same machine or another computer). All actions are logged in AuditTrail in ChromSword ClientService / Admin Console App

ClientServer

NodeJS based Windows Service that has TCP socket listening for JSON messages from other services and C# apps.

When testing make sure you STOP Windows services and instead run it in WebStorm from package.json in Debug.

Port. hostname and server report path is taken from RegEdit


xxxxxxxxxx
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const CHROMSWORD_KEY_REG='SOFTWARE\\Chromsword\\Auto';
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const CHROMSWORD_KEY_REG_32='SOFTWARE\\WOW6432Node\\Chromsword\\Auto';
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const CHROMSWORD_VALUE_ADDRESS='ClientServerAddress';
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const CHROMSWORD_VALUE_STORAGE_PATH='ClientServerStoragePath';
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const CHROMSWORD_VALUE_REPORT_SERVICE_TIMEOUT='ClientServerReportServiceTimeout';

All REST JSON service Message Types that are currently implemented (https://bitbucket.org/evaldsurtans/chromsword5-1-client-server-nodejs/src/master/app/common/RequestMessageTypes.js)


x
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 None: 0,
2

3
    InvalidChecksum: 1, //Suspected message spoofing
4

5
    Login: 2,
6
    Logout: 3,
7

8
    AccessInstrument: 4,
9
    AccessProject: 5,
10

11
    CreateProject: 6,
12
    SignProject: 7,
13

14
    AuditTrail: 8,
15

16
    StoreRun: 9,
17
    StorePeakTable: 10,
18
    StoreMethod: 11,
19

20
    StoreOriginalRPTX: 12,
21
    StoreOriginalPRJX: 13,
22

23
    AdminViewUsers: 14,
24
    AdminViewUser: 141,
25
    AdminCreateUser: 15,
26
    AdminEditUser: 16,
27
    AdminDeleteUser: 17,
28

29
    AdminViewRoles: 18,
30
    AdminViewRole: 181,
31
    AdminCreateRole: 19,
32
    AdminEditRole: 20,
33
    AdminDeleteRole: 21,
34

35
    AdminViewInstruments: 22,
36
    AdminViewInstrument: 221,
37
    AdminCreateInstrument: 23,
38
    AdminEditInstrument: 24,
39
    AdminDeleteInstrument: 25,
40

41
    AdminViewDatabases: 26,
42
    AdminCreateDatabase: 27,
43
    AdminEditDatabase: 28,
44
    AdminDeleteDatabase: 29,
45

46
    InvalidSession: 30,
47

48
    AdminViewProjectGroups: 31,
49
    AdminViewProjectGroup: 311,
50
    AdminCreateProjectGroups: 33,
51
    AdminEditProjectGroups: 34,
52
    AdminDeleteProjectGroups: 35,
53

54
    AdminViewAuditTrail: 36,
55
    AdminViewAuditTrailDetail: 366,
56

57
    AvailableProjectGroups: 37,
58
    AvailableInstruments: 38,
59

60
    UpdateProject: 39,
61
    UpdateReport: 40,
62

63
    PasswordExpired: 41,
64

65
    CheckProjectName: 42, //Project name must be unique within project group
66

67
    AdminViewProjects: 43,
68
    AdminViewProject: 44,
69
    AdminEditProject: 45,
70
    AdminDeleteProject: 46,
71

72
    AdminDownloadProjectFile: 47,
73

74
    AdminViewReports: 48,
75
    AdminViewReport: 49,
76
    AdminEditReport: 50,
77
    AdminDeleteReport: 51,
78
    AdminDownloadReportFile: 52,
79

80
    CreateReport: 53,
81

82
    StartProjectExecution: 54,
83
    FinishProjectExecution: 55,
84

85
    AccessReport: 56,
86

87
    AdminViewOverview: 57,
88

89
    AdminViewProjectReportDetails: 58,
90

91
    InvalidRepeatedRequest: 60,
92

93
    AdminViewSettings: 61,
94
    AdminEditSettings: 62,
95
}

ReportService

NodeJS based Windows Service that sends to ClientServer files that have not been sent to ClientServer imeaditly because of connection issues

AdminConsole

NodeJS Electorn App using Angular.Js V1 library for UI. To debug make sure you launch with environment variable ENV=DEVELOPMENT

Login Window with DEBUG panel on right! CSA AdminConsoile Break points does not work, but you can use Chrome Developer tools in browser window. Client Server and Report Server DEBUG does work

All Views ar based on https://bitbucket.org/evaldsurtans/git-bitbucket.org-evaldsurtans-chromsword5-1-admin-console/src/master/app/views/MainWindow.html AND https://bitbucket.org/evaldsurtans/git-bitbucket.org-evaldsurtans-chromsword5-1-admin-console/src/master/app/controllers/MainWindow.js

ViewOverview (https://bitbucket.org/evaldsurtans/git-bitbucket.org-evaldsurtans-chromsword5-1-admin-console/src/master/app/views/ViewOverview.html AND https://bitbucket.org/evaldsurtans/git-bitbucket.org-evaldsurtans-chromsword5-1-admin-console/src/master/app/controllers/ViewOverview.js) shows statistics recorded in DB

ChromSword AdminConsole workst through REST JSON API and not accessing all API requests are eqectuted using https://bitbucket.org/evaldsurtans/git-bitbucket.org-evaldsurtans-chromsword5-1-admin-console/src/master/app/services/ClientServer.js

Stats collected in this way:


x
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// Load available project groups
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let response = await $ClientServer.send({
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    messageType: $ClientServer.messageTypes.AvailableProjectGroups,
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    offset: 0,
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    limit: 255
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});
7

8
if(response.success) {

ViewAudiTrial (https://bitbucket.org/evaldsurtans/git-bitbucket.org-evaldsurtans-chromsword5-1-admin-console/src/master/app/controllers/ViewAuditTrail.js) - All actions that happen in AdminConsole and other CSA apps must be logged in AuditTrail and also must be possible to download PRJX, RTPX before and after every change

https://bitbucket.org/evaldsurtans/git-bitbucket.org-evaldsurtans-chromsword5-1-admin-console/src/master/app/controllers/ViewInstruments.js – To use any Instruments in ChromSword Auto user must first register instrument and access to user to this instrument, otherwise cannot run it

ProjectGroups

Projects - These are PRJX files - like ChromSword DataSystem Project file (coppied as file and also in DB)

Reports

Users

Roles (optional)

Settings

If mouse is moved then refresh session token

RPTX, PRJX with 5.5 support

Inside file there is few records that mark 5.5 files which have limited access. Hash is used primarily if no connection to ClientServer - it uses unique hash uuid that is later registered in PostgreSQL with the proper timestamp

CSA Apps

API communication logic must be implemented in ClientServerController.cs (https://bitbucket.org/evaldsurtans/chromsword5/src/master/Chromsword.ClientServer/Controllers/ClientServerController.cs)

Checking Access to instrument (would be better to move whole code block to ClientServerController.cs)

Checking Access to reports:

To detect CSA 5.5 Client server version there is special flag in RegEdit and Version number 5.5

In apps there is Login dialog that is shared by all app instances and should be invalidated if all windows are closed or opening the first window

PostgreSQL

Dabase structure dumped here: https://bitbucket.org/evaldsurtans/chromsword5-1-client-server-nodejs/src/master/pg_dump/ Normally this is installed using InnoSetup, but can also be done manually For Database access use WebStorm database viewer and connect to localhost PostgreSQL

Data structure

InnoSetup

InnoSetup is about the same as for ChromSword 5.x, but there are few extra installations.

It installs PostgreSQL
It restores DB without touching existing data, for example:


x
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1
; call function pg_terminate_backend to kill connections
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Filename: "{cmd}"; Parameters: "/c SET PGPASSWORD=b718fe553dc1c80d2637&& ""C:\Program Files (x86)\PostgreSQL\9.6\bin\psql.exe"" -U postgres -c ""SELECT pg_terminate_backend(pid) FROM pg_stat_activity WHERE datname = 'clientserver';"" "; \
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  Flags: waituntilterminated runhidden runascurrentuser; WorkingDir: "{app}"; StatusMsg: "Installing database... (part 1/3)"; Check: CheckClientServer;

Registers Windows Services that are running in background


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; ClientServer service runhidden
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Filename: "{cmd}"; Parameters: "/c npm run service-register"; \
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  WorkingDir: "{app}\ClientServer"; StatusMsg: "Installing services..."; \
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  Flags: waituntilterminated runhidden runascurrentuser;  Check: CheckClientServer;

Task - Tutorial

Create report with questions and screenshot after every step in Notion.

Install http://client:newversionscsa@versions.chromsword.com/ChromswordAuto_5.5.372.1028.exe or latest version (obtain full ChromSword 5.5 License Key from LicenseAdmin in seperate project)
It will install all Windows Services, PostgreSQL and database (later when debugging remember to stop in Windows Services ClientServer service and if necessary also Report Service)
Log in “ChromSword AdminConsole”
Create Project Group “Test project group #1”
Configure Instument as 127.0.0.1 Simulator
Start ChromSword DataSystem, login using CSA 5.5 credentials, Choose Project Group “Test project group #1” (in second step of setting method). This option is not visible in other CSA versions, just 5.5
Start experiment in simulator
In “ChromSword AdminConsole” Look if all actions are logged in “Audit Trail”
After Run try to download Project and Report from “ChromSword AdminConsole” sections
Open in Report in “ChromSword ReportViewer”, there should be LogIn dialog, then re-integrate some run chromatogram, check if changes are logged in “Audit Trail”
Create another user “test_user_2” with Project Group “Test project group #2”, but give access to same instrument
Create another experiment and check if this user cann access previosu experiment in “Test project group #1” - user should not be able to open it!
Stop Windows Services “ChromSword ClientServer” “ChromSword ReportViewer”, close “ChromSword AdminConsole”
Using WebStorm Start these 3 projects in DEBUG mode, see in console all actions happening
Repeat whole series of experiments