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Template IL CSV Scratch

This two page document is an inventory list of computerized systems used within a department. The list includes the type of equipment, identification details, purpose, software and hardware details, risk assessments, and validation documentation. System owners, business owners, and administrators are also documented for each system.

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Qc
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0% found this document useful (0 votes)
135 views2 pages

Template IL CSV Scratch

This two page document is an inventory list of computerized systems used within a department. The list includes the type of equipment, identification details, purpose, software and hardware details, risk assessments, and validation documentation. System owners, business owners, and administrators are also documented for each system.

Uploaded by

Qc
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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Page 1 of 2

Inventory List CSV

Doc ID : [Text]
Date :

This inventory contains a list of system and computerized systems used within or
provided by the department.

Name/Function Date Signature


Author

[Name]
[Title]

Approved

[Name]
[Title]

[Name]
[Title]

[Name]
[Title]

[Name]
[Title]

Document History

Version Date Effective Date Comments

[Text] [Text] [Text]


Page 2 of 2

PT Ciba Vision

Inventory List CSV


Doc ID : [Text]

Date : 30-Dec-1899

No. Type of Equipment / Equipment / Equipment Components Short Description of Equipment / Asset Tag / Application Connected Operating Access Level GAMP Computer Networked Inisial Risk GxP ERES Audit Trail Data to be Backup Password Area Building / System Owner Business Owner List of Administrator System Validation Valid Date Next Validation Computer Comment
equipment / System ID System Purpose System Serial NR Software to PC.. System Category System (Y/N) Assesssme (Y/N) (Y/N) (Y/N) back-up Frequency Management Room (ex. Admin 1, Admin Status Status System
System Name Version (With Classification nt 2) Management
Version) SOP
First Last First Last
Name Name Name Name

HMI: Machine
BFS Weiler Filling
1 Machine PR01A HMI: CIP dan SIP Proses filling BFS Process Automation N Y Y One Time Password Production
Machine
HMI: Pengukuran F0, Suhu dan Partikel count

2 Fedegari System Muhammad Nurhadi

3 Plasma System Muhammad Nurhadi

Spectrum, Audit
FTNIR Spectrum Spectrum ES Noorcahya
4 FTNIR 73024 NA Analys IPA Spectrum 100 N 81697 Laboratory System N Y Y Y Trail, Method, Monthly Aging Password Analytical lab 203/ Analytical Lab Setiawan In Operational Validated
100 10.03.08 nti
Database

Gas Gas Noorcahya


5 73029 NA 7890A US10907036 Laboratory System N Y Y Y Monthly Analytical lab 203/ Analytical Lab Setiawan In Operational Validated
Chromatography Chromatography nti

Noorcahya
6 UV Visible Cary 300 Setiawan
nti

Spectrum, Audit
Spectrum ES Noorcahya
7 FTIR 73025 FTIR Spectrum 100 NA Analyze material Spectrum 100 81929 Laboratory System N Y Y Y Trail, Method, Monthly Aging Password Analytical lab 203/ Analytical Lab Setiawan In Operational Validated
10.03.08 nti
Database

Noorcahya
8 HPLC 73200 HPLC NA e2695 Laboratory System N Y Y Y Monthly Analytical lab 203/ Analytical Lab Setiawan In Operational Validated
nti

XPS # 1 - SAGE Plasma Surface Thickness XPS # 1 - SAGE CIBA VISION


10 007/1996 4 Process Automation N Y N Plasma Area Lot 203 Lim Yin Nyan Validated 2011 Re-evaluation in 2016
100 SUN Qualitative Analysis 100 SUN Automation 1.13.0

XPS # 2 - SAGE Plasma Surface Thickness XPS # 2 - SAGE CIBA VISION


018/2004 4 Process Automation N Y N Plasma Area Lot 203 Lim Yin Nyan Validated 2011 Re-evaluation in 2017
SUN HR Qualitative Analysis SUN HR Automation 1.13.0

11 Ellipsometer Lim Yin Nyan

Consort D230 Data


12 Lim Yin Nyan
Logger (IPc)

Capture and tabulate equipment


Nikon V-12 Digital
13 measurement result from Nikon 1.0 5 Spreadsheet N Y N QC PAI Lot 204 Lim Yin Nyan Validated 2013 Re-evaluation in 2016
Counter
Projector
Capture and tabulate equipment
Mark-10 Force
14 measurement result from Peel 1.0 5 Spreadsheet N Y N QC PAI Lot 204 Lim Yin Nyan Validated 2013 Re-evaluation in 2016
Gauge
Force Gauge

15 JLR Lim Yin Nyan

16 ClearWave Lim Yin Nyan

FreshLook Filler/
17 Russell Morris
Closer

FreshLook Thermal
18 Russell Morris
Cure

FreshLook Tray
19 Russell Morris
Clean Out

FreshLook Mold
20 Russell Morris
Opener

21 FreshLook Printer Russell Morris

22 FreshLook Delenser Russell Morris

FreshLook
23 Accusentry Lens Russell Morris
Inspection

FreshLook Primary
24 Russell Morris
Packaging System

FreshLook
25 FinnAqua Sterilizer Russell Morris
System

FreshLook Koch
26 Russell Morris
Die Cutter

FreshLook Koch
27 Russell Morris
Cartoner

ActivPlant Data
28 Russell Morris
Historian

Stop Gap Primary


29 Muhammad Nurhadi
Packaging System

ATS Super Track


30 Primary Packaging Muhammad Nurhadi
System
Super Tortoise
31 Primary Packaging Muhammad Nurhadi
System
Super Langen
32 Secondary Muhammad Nurhadi
Packaging System

33 Kaye Validator Frederico Borromeo

Power Off and


Pujimulyon
34 Tear/ Fracture Achsan
o
Database

ClearWave Report
35 Janiah Ibrahim
Template

Japan Pre-
36 Janiah Ibrahim
Shipment Database

37 SVSP Janiah Ibrahim

38 TVSP Janiah Ibrahim

39 PASP Janiah Ibrahim

Batch Formula
40 Janiah Ibrahim
Record Database

Power Cylinder
41 Janiah Ibrahim
Axis Spc template

Base Curve and


42 Janiah Ibrahim
Diameter template

Carbazole Violet
UV Absorbing Herkuswyn
43 Wahab
Solution a
Formulation
FreshLook UV
Absorbing LiteTint Herkuswyn
44 Wahab
Monomer Solution a
Formulation

Dimension Black Herkuswyn


45 Wahab
Ink Template a

Ink Formulation Herkuswyn


46 Wahab
Template a

Activation Solution Herkuswyn


47 Wahab
Label a

Dispensed Herkuswyn
48 Wahab
Monomer Label a

Herkuswyn
49 Ink Paste label Wahab
a

Herkuswyn
50 Clear Paste Label Wahab
a

Herkuswyn
51 BinderCal Template Wahab
a

Sator Standalone
52 Muhammad Nurhadi
Database

PS-48 Tray
53 Barcode Scanning Muhammad Nurhadi
System

21 CFR Part 11
54 Karel Meka
Template

55 Validation Log Karel Meka

Barcode Label
Comparator (used
56 Edward Mulyana
in warehouse for
FG shipment)
Final Product
Retention (used in
57 Production & Edward
Warehouse for
Retention samples)
Inspection Custing Cap/ Incoming 203 / Custing Cup
58 Optical 73206 Avant NA Avant ZIP 200 AZ2001251 Laboratory System N Y N N Method NA Aging Password In Development Validated BTMDOC-00111
Measurement System Inspection Inspection Room
MeasureMind 3D Incoming 203 / Custing Cup
59 Optical 73230 Smartscope OGP NA Inspection Custing Cap Flash 302 SVW3024286 Laboratory System N Y N N Method NA Aging Password In Development Validated BTMDOC-00111
MultiSensor 15.2.23 Inspection Inspection Room

Spectrum, Audit
FTNIR Spectrum Spectrum ES
60 FTNIR 73031 NA Analys IPA Spectrum One NTS 68352 Laboratory System N Y Y Y Trail, Method, Monthly Aging Password Analytical lab 203/ Analytical Lab In Operational Validated
One NTS 10.03.08
Database
Spectrum, Audit
UV-VIS
61 73026 Cary 300 Conc NA Analize material EL08023629 Cary WinUV 4.20 Laboratory System N Y Y Y Trail, Method, Monthly Aging Password Analytical lab 203/ Analytical Lab In Operational Validated
Spectrophotometer
Cary 300 Conc Database

62

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