Software Validation Categories

COMPUTER SYSTEM VALIDATION (CSV)
1

[b]Hi Guys,

We are putting together a list of all possible projects/work associated with CSV or Software Validation, here’s what we have so far. Please add to the list so we can make it as comprehensive as possible. Instead of giving actual specific manufacturers lets have broad categories initially.[b]

All input greatly appreciated![/b][/b][b]

  • [b]LIMS Validation[/b]
  • [b]SAP Validation[/b]
  • [b]MES Validation[/b]
  • [b]Excel or Spread Sheet Validation[/b]
  • [b]CAPA Validation[/b]
  • [b]Document Management Validation[/b]
  • [b]Training Validation[/b]
  • [b]Minitab Validation[/b]
[/b][b][b]Regards

Graham OKeeffe[/b][/b]

2

Instead of giving actual specific manufacturers lets have broad categories initially.

I do support that idea of NOT being manufacturer / editor specific, therefore I would replace “SAP” by “ERP” and “Minitab” by “Statistical systems”!!

Further proposed categories:

Building Management Systems (BMS)
Warehouse Management Systems (WMS)
Maintenance Management Systems (MMS)
Chromatography Data Systems (CDS)
… and DCS/PLC/SCADA… Depending whether you aim considering only “pure” IS or wish to be more shopfloor oriented…

3

Good points Dark Validator…I agree

4

Here’s an update:

[table]
[tr]
[td]Number
[/td]
[td]Description
[/td]
[/tr]
[tr]
[td]1
[/td]
[td]LIMS
[/td]
[/tr]
[tr]
[td]2
[/td]
[td]ERP
[/td]
[/tr]
[tr]
[td]3
[/td]
[td]MES
[/td]
[/tr]
[tr]
[td]4
[/td]
[td]Excel or Spreadsheet
[/td]
[/tr]
[tr]
[td]5
[/td]
[td]CAPA
[/td]
[/tr]
[tr]
[td]6
[/td]
[td]Document Management
[/td]
[/tr]
[tr]
[td]7
[/td]
[td]Training
[/td]
[/tr]
[tr]
[td]8
[/td]
[td]Statistical Software
[/td]
[/tr]
[tr]
[td]9
[/td]
[td]Automation
[/td]
[/tr]
[tr]
[td]10
[/td]
[td]Building Management Systems (BMS)
[/td]
[/tr]
[tr]
[td]11
[/td]
[td]Warehouse Management Systems (WMS)
[/td]
[/tr]
[tr]
[td]12
[/td]
[td]Maintenance Management Systems (MMS)
[/td]
[/tr]
[tr]
[td]13
[/td]
[td]Chromatography Data Systems (CDS)
[/td]
[/tr]
[tr]
[td]14
[/td]
[td]Clinical Data Management
[/td]
[/tr]
[tr]
[td]15
[/td]
[td]Clinical Trial Management
[/td]
[/tr]
[tr]
[td]16
[/td]
[td]Laboratory Notebook
[/td]
[/tr]
[tr]
[td]17
[/td]
[td]Serial Management
[/td]
[/tr]
[tr]
[td]18
[/td]
[td]Master Data Management
[/td]
[/tr]
[tr]
[td]19
[/td]
[td]MS Access
[/td]
[/tr]
[tr]
[td]20
[/td]
[td]Bespoke Software
[/td]
[/tr]
[tr]
[td]21
[/td]
[td]Quality Management System
[/td]
[/tr]
[tr]
[td]22
[/td]
[td]Process Control
[/td]
[/tr]
[/table]

5

Supervisory Control and Data Acquisition (SCADA) systems belong on the list.

Also Training software, if that isn’t already listed.

6

[quote=kaysee12]Supervisory Control and Data Acquisition (SCADA) systems belong on the list.

Also Training software, if that isn’t already listed.[/quote]

Thank you Kaysee,

Updated list:

[table]
[tr]
[td]Number
[/td]
[td]Description
[/td]
[/tr]
[tr]
[td]1
[/td]
[td]LIMS
[/td]
[/tr]
[tr]
[td]2
[/td]
[td]ERP
[/td]
[/tr]
[tr]
[td]3
[/td]
[td]MES
[/td]
[/tr]
[tr]
[td]4
[/td]
[td]Excel or Spreadsheet
[/td]
[/tr]
[tr]
[td]5
[/td]
[td]CAPA
[/td]
[/tr]
[tr]
[td]6
[/td]
[td]Document Management
[/td]
[/tr]
[tr]
[td]7
[/td]
[td]Training Software
[/td]
[/tr]
[tr]
[td]8
[/td]
[td]Statistical Software
[/td]
[/tr]
[tr]
[td]9
[/td]
[td]Automation
[/td]
[/tr]
[tr]
[td]10
[/td]
[td]Building Management Systems (BMS)
[/td]
[/tr]
[tr]
[td]11
[/td]
[td]Warehouse Management Systems (WMS)
[/td]
[/tr]
[tr]
[td]12
[/td]
[td]Maintenance Management Systems (MMS)
[/td]
[/tr]
[tr]
[td]13
[/td]
[td]Chromatography Data Systems (CDS)
[/td]
[/tr]
[tr]
[td]14
[/td]
[td]Clinical Data Management
[/td]
[/tr]
[tr]
[td]15
[/td]
[td]Clinical Trial Management
[/td]
[/tr]
[tr]
[td]16
[/td]
[td]Laboratory Notebook
[/td]
[/tr]
[tr]
[td]17
[/td]
[td]Serial Management
[/td]
[/tr]
[tr]
[td]18
[/td]
[td]Master Data Management
[/td]
[/tr]
[tr]
[td]19
[/td]
[td]MS Access
[/td]
[/tr]
[tr]
[td]20
[/td]
[td]Bespoke Software
[/td]
[/tr]
[tr]
[td]21
[/td]
[td]Quality Management System
[/td]
[/tr]
[tr]
[td]22
[/td]
[td]Process Control
[/td]
[/tr]
[tr]
[td]23
[/td]
[td]SCADA
[/td]
[/tr]
[/table]

7

Good update.

8

Great List
How about
Distributed Control Systems (DCS)
Data Historians
Electronic Batch Record Systems

9

Nice additions Russ, updated list below

[quote=RR410]Great List
How about
Distributed Control Systems (DCS)
Data Historians
Electronic Batch Record Systems[/quote]

[table]
[tr]
[td]Number
[/td]
[td]Description
[/td]
[/tr]
[tr]
[td]1
[/td]
[td]LIMS
[/td]
[/tr]
[tr]
[td]2
[/td]
[td]ERP
[/td]
[/tr]
[tr]
[td]3
[/td]
[td]MES
[/td]
[/tr]
[tr]
[td]4
[/td]
[td]Excel or Spreadsheet
[/td]
[/tr]
[tr]
[td]5
[/td]
[td]CAPA
[/td]
[/tr]
[tr]
[td]6
[/td]
[td]Document Management
[/td]
[/tr]
[tr]
[td]7
[/td]
[td]Training Software
[/td]
[/tr]
[tr]
[td]8
[/td]
[td]Statistical Software
[/td]
[/tr]
[tr]
[td]9
[/td]
[td]Automation
[/td]
[/tr]
[tr]
[td]10
[/td]
[td]Building Management Systems (BMS)
[/td]
[/tr]
[tr]
[td]11
[/td]
[td]Warehouse Management Systems (WMS)
[/td]
[/tr]
[tr]
[td]12
[/td]
[td]Maintenance Management Systems (MMS)
[/td]
[/tr]
[tr]
[td]13
[/td]
[td]Chromatography Data Systems (CDS)
[/td]
[/tr]
[tr]
[td]14
[/td]
[td]Clinical Data Management
[/td]
[/tr]
[tr]
[td]15
[/td]
[td]Clinical Trial Management
[/td]
[/tr]
[tr]
[td]16
[/td]
[td]Laboratory Notebook
[/td]
[/tr]
[tr]
[td]17
[/td]
[td]Serial Management
[/td]
[/tr]
[tr]
[td]18
[/td]
[td]Master Data Management
[/td]
[/tr]
[tr]
[td]19
[/td]
[td]MS Access
[/td]
[/tr]
[tr]
[td]20
[/td]
[td]Bespoke Software
[/td]
[/tr]
[tr]
[td]21
[/td]
[td]Quality Management System
[/td]
[/tr]
[tr]
[td]22
[/td]
[td]Process Control
[/td]
[/tr]
[tr]
[td]23
[/td]
[td]SCADA
[/td]
[/tr]
[tr]
[td]24
[/td]
[td]Distributed Control Systems (DCS)
[/td]
[/tr]
[tr]
[td]25
[/td]
[td]Data Historians
[/td]
[/tr]
[tr]
[td]26
[/td]
[td]Electronic Batch Record Systems
[/td]
[/tr]
[/table]

10

Chromatographic data system is specific. Should also laboratory data systems eg. auto-titrators, UV, AA

Label printing systems specifically barcodes, status labels

Counting scales software

jay

11

Hi Jay,

These will fall under the major category of laboratory, as they are integral to the laboratory equipment themselves.

Cheers!

[quote=Jay]Chromatographic data system is specific. Should also laboratory data systems eg. auto-titrators, UV, AA

Label printing systems specifically barcodes, status labels

Counting scales software

jay[/quote]

12

Hi,

Submission management system
Enterpise compliance management software
eCTD (publishers, validators)

Regards
Shaamu