TOC-L OQR Rev1.04 ZEMH-8100D

ZEHM-8100D
Document No.:
SHIMADZU TOC SYSTEM

Operational Qualification
Operational Qualification Report
System Name
System ID No.
Installation Site
The undersigned Performer reports that the Operational Qualification Protocol has been successfully completed for the
system stated above.
 Performer Signature Date
Print / /
Company
The undersigned Reviewer and Manager report that the Performer has completed the Operational Qualification Protocol
successfully.
 Reviewer Signature Date
Print / /
Company
 Manager Signature Date
Print / /
Company
Operational Qualification Table of Contents
Table of Contents
1. Definitions .................................................................................................................................... 3
1-1 Documentation ................................................................................................................................... 3
1-2 Scope .................................................................................................................................................. 4
1-3 Entries and Revisions ......................................................................................................................... 5
2. Preliminary Checks ..................................................................................................................... 6
2-1 Reviewer Designation and Recording ................................................................................................ 6
2-2 Performer Identification and Approval............................................................................................... 7
2-3 Planning Items to Be Evaluated in Operational Qualification ........................................................... 9
2-4 Calibration Certification and Instruments Used ............................................................................... 10
2-5 Other Tools Used ............................................................................................................................... 11
3. Operational Qualification Record ........................................................................................... 12
4. Attached Documents ................................................................................................................. 24
Rev1.04 Page 2 of 24
Operational Qualification Definitions
1. Definitions
1-1 Documentation
1. The purpose of this document is to record the results of the Operational Qualification implemented on the
Shimadzu Total Organic Carbon Analyzer. If the inspections pass the criteria and the results have been
approved, it is verified that the system operates to satisfy the intended purpose.
2. The following are established as the responsible parties in the execution of inspections.
Performer
The Performer is the individual who actually performs the procedures stipulated in the Installation
Qualification Protocol and the Operational Qualification Protocol.
The Performer shall either be an individual who, having been trained by the Quality Assurance Department
of the Analytical & Measuring Instruments Division of Shimadzu Corporation, has been certified as an
IQ/OQ inspector by the General Manager of the Quality Assurance Department, or, an individual recognized
by the Manager to be equipped with the ability to conduct this inspection.
Reviewer
The Reviewer is an individual designated by the Manager charged with responsibility for the system.
The Reviewer verifies the contents of the Installation Qualification Protocol and the Operational
Qualification Protocol. In addition, the Reviewer shall attend the inspection procedures together with the
Performer, and evaluate the procedures.
The Manager can serve concurrently as the Reviewer.
Manager
The Manager is the individual responsible for administering the entire TOC system being inspected.
As well as verifying the contents of the Installation Qualification Protocol and the Operational Qualification
Protocol, the Manager shall also grant final approval to the inspection procedures.
3. The Performer shall check each unit and execute inspections in accordance with the procedures described in
the Operational Qualification Protocol (Document No. ). After checking
all items, the Performer shall sign and date the cover sheet of this document and submit this document as a
report.
(OQ must be performed by a trained and knowledgeable individual in accordance with 21 CFR Part 211
Section 211.25 (cGMP, USA promulgated 29 September 1978)).
4. The Reviewer shall first check the content of this entire document. After each inspection is finished, the
Reviewer shall check their results. After checking all items, the Reviewer shall sign and date the cover sheet
of this document as approval of the Operational Qualification.
5. The Manager shall first check the content of this entire document. After the performance of all items
stipulated in the Operational Qualification Protocol, the Manager shall check their results. The Manager shall
enter a unique document control number in the Document No. space at the top right of the cover sheet, and
then sign and date the cover sheet of this document as final approval of the Operational Qualification.
6. This document is comprised of 1. Definitions, 2. Preliminary Checks, 3. Operational Qualification Record,

and 4. Attached Documents. All of these sections must be included.
7. This document contains important information and any form of duplication, photography, or reproduction
without the permission of the General Manager of the Quality Assurance Department, Analytical &
Measuring Instruments Division, Shimadzu Corporation, is prohibited. However, the records of the
inspections conducted using this document may be duplicated at the discretion of the Manager.
Comment
 No
1-2 Scope
This Operational Qualification shall apply to the equipment installed at the following site.
(Address)
(Company)
(Department)
(Installation Site)
(System ID No.)
(Product Model Name)
Comment
 No
1-3 Entries and Revisions

1. Making Entries
Use a permanent ballpoint pen, or equivalent, when recording results.
Names should be clearly printed.
Confirm that all items are completed, and that there are no omissions.
Draw a diagonal line (from bottom left to top right) across all blank columns.
Columns in which nothing has to be written in have been filled in with "N/A" in advance.
If choices are available within an item, place a checkmark in the checkbox to select the appropriate
decision.
2. Rounding of numeric values

If there are more significant figures in the measurement results than the specified criteria, round off the
result value at the number of significant figures required for the criteria. For example, if the criterion is
defined down to the first decimal place, round off the figure at the second decimal place of the result
value.
3. Deleting or correcting mistakenly filled items

To correct mistaken entries, delete the entire entry by drawing a diagonal line through it and enter the
correction in the margins. To correct numerical values or symbols (checkmarks), draw 2 horizontal lines
across the mistake and rewrite the entry. Moreover, write the date, signature, and the reason for the
change in the "Comment" field.
If two or more corrections are made, clearly mark the corrected entries with numbers (1), (2), etc. Enter
the same number in the "Comment" field and add the date, reason, and a signature.
4. Changing or deleting steps, procedures or acceptance criteria

If there are parts of steps or procedures which will not be applied, draw a diagonal line through the
entire item, and write the necessary information, date, and signature in the "Comment" field. When
making a change, delete the existing description as explained above, and write the change point, date,
and signature in the "Comment" field.
5. Revising entries
If the need to alter the contents of an entry arises, change the entry in accordance with "3. Deleting or
correcting mistakenly filled items," and then write the reason for the change in the "Comment" field.
When adding a new description, write the change point, date, and signature in the "Comment" field.
6. Handling problems
Any problems that are identified in the Operational Qualification must be investigated and appropriate
actions must be taken. All such actions must be documented and be approved by the Manager.
7. In the event of a Fail

If troubles occur during an inspection and the item fails the inspection, place a checkmark in the "Fail"
checkbox and describe the outline of the problem in the "Comment" field of the relevant page. Also date
and sign the entry. After the problem is solved, describe the solution and the result ("Pass") in the
"Comment" field. Also date and sign the entry.
8. Addition of page
Pages can be added if necessary as a result of handling items 3 to 7 above. To add a page, append the
page number by adding an alphabet character starting with "A" to the original page number (e.g. 5-A),
and insert the new page after the relevant page. Also add the page number of the new page to the Table
of Contents.
9. Attaching data
Attached data are added by assigning page numbers as "A, B, C…" for each inspection item. If, for
example, there is a total of 3 sheets for attachment A, notate the pages as "A-1/3 – A-3/3," ensuring that
no numbers are omitted. The Performer shall date and sign the attached data.
Comment
 No
Operational Qualification Preliminary Checks
2. Preliminary Checks
2-1 Reviewer Designation and Recording

Before conducting this inspection, the Manager shall enter the name of the Reviewer he designated.
Reviewer
Name:
Date: / /
Use the spaces below if more than one Reviewer is to be set. If the spaces are not used, place a
checkmark in the "Not applicable" checkbox.
Reviewer 2 ( Not applicable)
Name:
Date: / /
Reviewer 3 ( Not applicable)
Name:
Date: / /
Comment
 No
2-2 Performer Identification and Approval

Identify and approve the Performer. Choose the entry section according to the way in which the Performer is
selected.
If revisions are to be made to the document by Performers other than the persons certified in the table below,
make a note of the fact that the Performer has been changed (qualification certificate number included) in the
Change List.
 If the Performer is a service technician authorized by Shimadzu Corporation
This is to certify that the below-signed person has received training in the Quality Assurance Department
of the Analytical & Measuring Instruments Division of Shimadzu Corporation. The person has been
certified by the General Manager of the Quality Assurance Department as a certified IQ/OQ inspector, as
proven by the certificate. The person performs the Operational Qualification Protocol as the Performer.
Performer
Name: Date: / /
Company name:
Certificate No.:
Signature:
Use the spaces below if more than one Performer is to be set. If the spaces are not used, place a
checkmark in the "Not applicable" checkbox.
Performer 2 (Not applicable)
Name: Date: / /
Company name:
Certificate No.:
Signature:
Performer 3 (Not applicable)
Name: Date: / /
Company name:
Certificate No.:
Signature:
The above-signed persons are hereby recognized as certified IQ/OQ inspectors and approved to
perform the Operational Qualification Protocol as the Performer.
Reviewer
Signature: Date: / /
Manager
Comment
 No
 If the Performer has been appointed by the Manager
Performer
Name: Date: / /
Company name:
Signature:
The above-signed person is hereby recognized as a certified IQ/OQ inspector and approved to perform
the Operational Qualification Protocol as the Performer.
Reviewer
Manager
Comment
 No
2-3 Planning Items to Be Evaluated in Operational Qualification

Prior to implementing this operational qualification, check the system configuration, determine the component
and system items to be evaluated and have them approved by signing the signature column at the end of this
section.
Checking Equipment Configuration

The units and accessories comprising this system are listed below. If the unit is included in the system, place a
checkmark in the "Applicable" box. If the unit is not included in the system, place a checkmark in the "Not
Applicable" box.
No signature or date entry is required for units or systems with a checkmark in the "Not Applicable" box on the
implementation record pages.
<Equipment configuration>
Not
Applicable Applicable Model Name
TOC Analyzer
  TOC-LCPH
  TOC-LCSH
  TOC-LCPN
  TOC-LCSN
Autosampler
  ASI-L
8-Port Sampler
  OCT-L (1)
  OCT-L (2) (as second unit)
Solid Sample Combustion Unit
  SSM-5000A
Data Processing Unit
  PC
  TOC-Control L
  LabSolutions
  CLASS-Agent
 Other Options
 
 
 
 
 
Comment
 No
2-4 Calibration Certification and Instruments Used

The instruments and reagents used in the inspections are listed below.
(1) Items prepared by the Shimadzu service company

* Microsyringe
 Microsylinge 5 mL (standard accessory for TOC-L C*) Control No. :
* Standard reagents for performance inspection

 Potassium hydrogen phthalate
Lot No. :___________________________________
(2) Items to be prepared by the customer
* Electronic balance
A calibrated balance capable of measuring down to 0.1 mg is required.
 Instrument name: ; Model: Control No. :

Inspection date: Expiry date:
* Whole pipette
Whole pipette for preparation of standard solution
(The amendment to the Measurement Law on November 1st 1993 excluded this item from the scope of the
Measurement Law.)

* Flasks
Volumetric flasks for preparation of standard solution
(The amendment to the Measurement Law on November 1st 1993 excluded this item from the scope of the
Measurement Law.)
* Standard reagents
 Reagent name: ; Model: Control No. :
 Reagent name: ; Model: Control No. :
Comment
 No
2-5 Other Tools Used

The tools, solvents etc. used in this inspection are indicated below.
These items are to be provided by the customer. If any of these cannot be obtained, please contact your Shimadzu
service representative.
(1) Items to be prepared by the customer

* Equipment
Set of glassware
Microsyringe ; Needle-tip type, 50 L, 1 pc (for SSM-5000A testing only)
* Solvents
Water ; TOC value recommended to be less than 100 ppb
*Other
High purity air ; CO2/CO/THC each present in concentrations less than 1.0 ppm
Pure oxygen gas ; Purity 99.9 % min. (for SSM-5000A testing only)
Quartz fiber filter paper ; Advantec Corp. QR100 type, about 50 sheets (for SSM-5000A testing only)
Comment
 No
Operational Qualification Operational Qualification Record
3. Operational Qualification Record

If the unit is included in the system to be inspected, place a checkmark in the "Applicable" box. If the unit is not
included in the system, place a checkmark in the "Not Applicable" box. Enter a diagonal line in the Pass/Fail
checkbox for "Not applicable" items.
3-1 TOC-Control L/LabSolutions  Applicable  Not Applicable
Model Name Personal Computer

Serial Number (S/N)
No. Item Criteria Inspection results Pass Fail N/A
1-1 Computer boot-up test Windows starts up normally.   

Computer Reference
Date and time are correct. / / / /
1-2 Time and date check   
Permitted range
: : : :
Drive Error Detection
"Disk Check Complete" is  C

1-3 Hard disk drive test   
displayed for all drives. 


Test page printed correctly.   
1-4 Print driver check Ver.
The driver version number matches the
Controlled   
controlled version number.
Ver.
Network connection test
Designated IP
1-5  Not implemented because not No packets lost.   
address
connected to network
TOC-Control L  Applicable  Not Applicable
The version number matches the Ver.

2-1 Software version check   
controlled version number. Controlled Ver.
2-2 Program alteration check "OK" is displayed for every item.  

Server name:
Shimadzu User Authentication Server name for the connected
Tool connection check   
database is correct.
2-3  Not implemented because not
used with TOC-Control L
（applicable to 2-3～2.9） Login possible from [View event log].   
Lockout event is recorded in TOC-Control L operation log.   
2-4 Security function test
Password log management
2-4-1 Duplicated passwords cannot be used.   
function check
Number of password characters A password shorter than the minimum length is not accepted.   
2-4-2 check
A password satisfying the minimum length is accepted.   
Login is not possible with an incorrect password but possible with the
2-4-3 Failed login detection   
correct password.
2-4-4 User lockout function check The user is locked out for the specified lockout time.   
2-4-5 Failed login log The login lockout is registered in the log.   
Comment
 No
2-5 User access rights check [Maintenance] is enabled for OQ_USER, but disabled for OQ_USER_1.   
System policy function check

 Not performed because the
2-6 [Recalculate] and [Delete] cannot be selected.   
"Recalculate" and "Delete"
functions are used.
2-7 Operation log check Date, Change Location and Reason are correctly displayed.   
The screen lock function operates.   
2-8 Screen lock function check OQ_USER_1 cannot unlock the screen but OQ_USER can unlock the
  
screen.
Test of function to prevent A message indicates that the specified user ID or user name already
2-9   
duplicate user registration exists and duplicate user registration is not possible.
2-10 Software function check Area value is 1830.   
LabSolutions Software  Applicable  Not Applicable
The version number matches the Controlled

Ver.   
controlled version number. Ver.
 LabSolutions   
   
3-1 Software version check    
   
   
   
3-2 Program alteration check "OK" is displayed for all software.   
Failed login detection and
3-3 A failed login attempt is registered in the log.   
record
Samples are searched correctly.   
3-4 Data display, search, and sort
Displayed sample and data information match “TEST 2-10”.   
3-5 Electronic signature check The information electronically signed in step is properly registered.   
3-6 Export function check The data is properly exported.   
3-7 Import function check The file specified is properly imported.   

3-8 Event Log registering check Event log is registered correctly.   
Shimadzu User Authentication The Shimadzu User Authentication Tool connection using database
3-9   
Tool connection check access and log registration.
A description of each operation indicated in step is recorded in the
3-10 Log recording check   
application log.
Comment
 No
3-2 TOC-Control L/CLASS-Agent  Applicable  Not Applicable
Model Name Personal Computer

Serial Number (S/N)
1-1 Computer boot-up test Windows starts up normally.   

Computer Reference
Date and time are correct. / / / /
1-2 Time and date check   
Permitted range
: : : :
Drive Error Detection
"Disk Check Complete" is  C

1-3 Hard disk drive test   
displayed for all drives. 


Test page printed correctly.   
1-4 Print driver check Ver.
The driver version number matches the
Controlled   
controlled version number.
Ver.
Network connection test
Designated IP
1-5  Not implemented because not No packets lost.   
address
connected to network
TOC-Control L  Applicable  Not Applicable
The version number matches the Ver.

2-1 Software version check   
controlled version number. Controlled Ver.
2-2 Program alteration check "OK" is displayed for every item.  

Server name:
2-3  Not implemented because not
used with TOC-Control L
（applicable to 2-3～2.9） Login possible from [View event log].   
Lockout event is recorded in TOC-Control L operation log.   
2-4 Security function test
function check
2-4-2 check
A password satisfying the minimum length is accepted.   
correct password.
Comment
 No
[Maintenance] is enabled for OQ_USER_2, but disabled for

2-5 User access rights check   
OQ_USER_1.
System policy function check
 Not performed because the
2-6 [Recalculate] and [Delete] cannot be selected.   
"Recalculate" and "Delete"
functions are not used.
2-7 Operation log Date, Change Location and Reason are correctly displayed.   
The screen lock function operates.   
2-8 Screen lock function check OQ_USER_1 cannot unlock the screen but OQ_USER_2 can unlock the
  
screen.
Test of function to prevent A message indicates that the specified user ID or user name already
2-9   
duplicate user registration exists and duplicate user registration is not possible.
2-10 Software function check Area value is 1830.   
CLASS-Agent Software  Applicable  Not Applicable
The version number matches the Controlled

Ver.   
controlled version number. Ver.
 CLASS-Agent Manager   
 Shimadzu User Authentication Tool   
3-1 Software version check    
   
   
   
3-2 Program alteration check "OK" is displayed for all software.   
Server name:
3-3  Not implemented because
already implemented in Test Login possible from [View event log].   
2-3
Lockout by AgentMan2.exe is registered.   
Security function tests
 Not implemented because
3-4
already implemented in Test
2-4
function check
3-4-2
check A password satisfying the minimum length is accepted.   
correct password.
Comment
 No
Login prohibited with an incorrect password but possible with the

  
correct password.
3-5 User access rights check
"User Administration" item is enabled for OQ_USER_2 but
  
disabled for OQ_USER_1.
Test of function to prevent Duplicate user cannot be registered and the message "Unable to set
3-6   
duplicate user registration the Login ID or User Name. It has been already used" appears.
Samples are searched correctly.   
Samples are displayed in correct sequence after a sort.   
3-7 Data display, search, and sort
Displayed sample and data information matches the TOC-Control
  
L report.
3-8 Data recovery Correct files exist in folder.   
TOC-Control L Manual Registration
TOC-Control L manual Data is manually registered to the database.   
4 registration function check
(Data integrity check) Data before and after registration are identical.   
5 Electronic signature check Electronic signature information is printed correctly.   
6 System log recording check Change to configuration settings is registered in the System Log.   
3-3 TOC-LCPH Total Organic Carbon Analyzer  Applicable  Not Applicable

(can be available to PC controll of CSH type)
Model Name TOC-LCPH
Serial Number (S/N)
1 LED test LEDs light in green.   

Version number is displayed. Ver.   
Firmware version
2 Controlled
check Version number matches the controlled version number.   
Ver.
TC slider operates without error.   
3 Sliders
IC slider operates without error.   
4 Syringe pump Syringe pump operates without error.   
5 8-port valve 8-port valve operates correctly when each port is selected.   
6 Flowrate test Flowrate from out let NDIR is 130-170ml/min   
AREA average
Measured AREA average is at least 66.   
value __
7 Sensitivity test
__ mV
Peak height is 70 mV at the most. Peak height   
less or equal
1. The CV value obtained from the measurement
of the 1.0 mg/L standard solution is within Reproducibility   
Reproducibility and ___．__ %
8 1.5 %.
linearity test
2. Linearity is within 2.0 % F.S. Linearity   
___．__ %
Comment
 No
3-4 TOC-LCSH Total Organic Carbon Analyzer  Applicable  Not Applicable

Model Name TOC-LCSH
Serial Number (S/N)
No. Item Criteria Inspection Results Pass Fail N/A
LEDs light in green.   

1 LCD and LED test
The instrument type is displayed on the LCD.   
Firmware version
2 Controlled
Ver.
TC slider operates without error.   
3 Sliders
IC slider operates without error.   
Printer operation
7 Printer prints properly.   
test
AREA average
Measured AREA average is at least 66.   
value __
8 Sensitivity test
__ mV
less or equal
1. The CV value obtained from the measurement of
Reproducibility   
Reproducibility and the 1.0 mg/L standard solution is within 1.5 %. ___．__ %
9
linearity test
2. Linearity is within 2.0 % Linearity   
___．__ %
Comment
 No
3-5 TOC-LCPN Total Organic Carbon Analyzer  Applicable  Not Applicable

(can be available to PC controll of CSN type)
Model Name TOC-LCPN
Serial Number (S/N)
1 LED test LEDs light in green.   

Firmware version
2 Controlled
Ver.
3 Slider TC slider operates without error.   
Difference of
Difference of average peak areas is at least 120.   
average peak areas __
7 Sensitivity test
__ mV
less or equal
1. The CV value obtained from the measurement
of the 30.0 mg/L standard solution is within Reproducibility   
Reproducibility and ___．__ %
8 1.5 %.
linearity test
___．__ %
Comment
 No
3-6 TOC-LCSN Total Organic Carbon Analyzer  Applicable  Not Applicable

Model Name TOC-LCSN
Serial Number (S/N)
LEDs light in green.   

1 LCD and LED test
The instrument type is displayed on the LCD.   
Firmware version
2 Controlled
Ver.
3 Slider TC slider operates without error.   
Printer operation
7 Printer prints properly.   
test
Difference of
Difference of average peak areas is at least 120.   
average peak areas __
8 Sensitivity test
__ mV
less or equal
1. The CV value obtained from the measurement of
Reproducibility   
Reproducibility and the 30.0 mg/L standard solution is within 1.5 %. ___．__ %
9
linearity test
___．__ %
Comment
 No
3-7 ASI-L Autosampler  Applicable  Not Applicable
Model Name ASI-L

Serial Number (S/N)
1 Rinse pump Rinse liquid flows normally from 2 rinse ports.

operation test   
2 Arm operation test Arm operates in up/down and forward/back directions.   

3 Turntable operation The turntable rotates without error.
  
test
4 Stirrer operation Stirrer operates normally in all vial positions.
test   
5 External sparge Solenoid valve normally open/close

test   
Comment
 No
3-8 OCT-L 1/OCT-L 2 (as a second unit)

3-8-1 OCT-L 8-Port Sampler  Applicable  Not Applicable
Model Name OCT-L

Serial Number (S/N)
1 8-port valve The port positions are correct, and each port operates smoothly
operation test to the designated position.   
3-8-2 OCT-L 8-Port Sampler (as a second unit)  Applicable  Not Applicable
Model Name OCT-L

Serial Number (S/N)
8-port valve The port positions are correct, and each port operates smoothly
1   
operation test to the designated position.
Comment
 No
3-9 SSM-5000A Solid Sample Combustion Unit  Applicable  Not Applicable
Model Name □SSM-5000A □SSM-5000A＋Cell switching ASSY

Serial Number (S/N)
The "TC spl. exchange" and "TC meas. pos" functions turn
  
CLOSE/OPEN at the designated positions.
The "IC spl. exchange" and "IC meas.pos" functions turn
1 Function test   
CLOSE/OPEN at the designated positions.
The cooling fan turns with the toggle operation of
  
ON/OFF.
CV value of 3 measurement of glucose standard solution
2 Reproducibility test CV value ___.__ %   
results is within 2.0 %.
3 Linearity test Linearity is within 2.0 % fF.S. Linearity ___.__ %   
Comment
 No
Operational Qualification Attached Documents
4. Attached Documents
Attached
Description Page
Item
2-4 Calibration Certification
 Microsyringe ( ) Inspection report
 Potassium hydrogen phthalate Inspection report
 Electronic balance ( ) Traceability certificate
Attached Item Description Page

TOC-Control L
 3-1 Test 1-3 Hard disk drive check result Verification data Attachment 24-
 Test 1-4 Print driver test page Verification data Attachment 24-
 Test 1-5 Network connection test results Verification data Attachment 24-
 Test 2-2 TOC-Control L program alteration Attachment 24-
Verification data
check results
 Test 2-3 Lockout log Verification data Attachment 24-
 Test 2-7 Operation log Verification data Attachment 24-
 Test 2-10 TOC-Control L function check results Verification data Attachment 24-
LabSolutions
 3-1 Test 3-2 Program alteration check Verification data Attachment 24-
 Test 3-4 Data display, search, and sort Verification data Attachment 24-
 Test 3-5 Electronic signature check Verification data Attachment 24-
 Test 3-7 Import function check Verification data Attachment 24-
 Test 3-10 Log recording check Verification data Attachment 24-
CLASS-Agent
 3-2 Test 3-2 Program alteration check Verification data Attachment 24-
 Test 3-7 Data display, search, and sort Verification data Attachment 24-
 Test 5 Electronic signature check Verification data Attachment 24-
 Test 6 System log recording check Verification data Attachment 24-
TOC-L CPH
 3-3 Test 7 Sensitivity test results Verification data Attachment 24-
 Test 8 Repeatability and linearity test results Verification data Attachment 24-
TOC-L CSH
 3-4 Test 7 Printer operation test Verification data Attachment 24-
 Test 8 Sensitivity test results Verification data Attachment 24-
TOC-L CPN
 3-5 Test 7 Sensitivity test results Verification data Attachment 24-
TOC-L CSN
 3-6 Test 7 Printer operation test Verification data Attachment 24-
 Test 8 Sensitivity test results Verification data Attachment 24-
SSM-5000A
 3-9 Test 1 Repeatability test results Verification data Attachment 24-
 Test 2 Linearity test results Verification data Attachment 24-
* Number the attached data by adding an alphabetical letter (starting from A) to the final page number (e.g.,
Attachment 24-A-1/3 – 3/3). Fill in the table above and attach the data to this document.
Comment
 No

TOC-L OQR Rev1.04 ZEMH-8100D

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TOC-L OQR Rev1.04 ZEMH-8100D

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ZEHM-8100D

SHIMADZU TOC SYSTEM

Operational Qualification Report

 Performer Signature Date

 Reviewer Signature Date

 Manager Signature Date

4. Attached Documents ................................................................................................................. 24

6. This document is comprised of 1. Definitions, 2. Preliminary Checks, 3. Operational Qualification Record,

(Product Model Name)

1-3 Entries and Revisions

2. Rounding of numeric values

3. Deleting or correcting mistakenly filled items

4. Changing or deleting steps, procedures or acceptance criteria

7. In the event of a Fail

2-1 Reviewer Designation and Recording

Reviewer 2 ( Not applicable)

Reviewer 3 ( Not applicable)

2-2 Performer Identification and Approval

 If the Performer is a service technician authorized by Shimadzu Corporation

2-3 Planning Items to Be Evaluated in Operational Qualification

Checking Equipment Configuration

2-4 Calibration Certification and Instruments Used

(1) Items prepared by the Shimadzu service company

* Standard reagents for performance inspection

(2) Items to be prepared by the customer

 Instrument name: ; Model: Control No. :

 Instrument name: ; Model: Control No. :

2-5 Other Tools Used

(1) Items to be prepared by the customer

3. Operational Qualification Record

Model Name Personal Computer

No. Item Criteria Inspection results Pass Fail N/A

1-1 Computer boot-up test Windows starts up normally.   

Drive Error Detection

"Disk Check Complete" is  C

TOC-Control L  Applicable  Not Applicable

The version number matches the Ver.

2-2 Program alteration check "OK" is displayed for every item.  

No. Item Criteria Inspection results Pass Fail N/A

System policy function check

LabSolutions Software  Applicable  Not Applicable

The version number matches the Controlled

3-6 Export function check The data is properly exported.   

3-7 Import function check The file specified is properly imported.   

3-2 TOC-Control L/CLASS-Agent  Applicable  Not Applicable

Model Name Personal Computer

No. Item Criteria Inspection results Pass Fail N/A

1-1 Computer boot-up test Windows starts up normally.   

Drive Error Detection

"Disk Check Complete" is  C

TOC-Control L  Applicable  Not Applicable

The version number matches the Ver.

2-2 Program alteration check "OK" is displayed for every item.  

No. Item Criteria Inspection results Pass Fail N/A

[Maintenance] is enabled for OQ_USER_2, but disabled for

CLASS-Agent Software  Applicable  Not Applicable

The version number matches the Controlled

No. Item Criteria Inspection results Pass Fail N/A

Login prohibited with an incorrect password but possible with the

3-3 TOC-LCPH Total Organic Carbon Analyzer  Applicable  Not Applicable

No. Item Criteria Inspection results Pass Fail N/A

1 LED test LEDs light in green.   

3-4 TOC-LCSH Total Organic Carbon Analyzer  Applicable  Not Applicable