ZEMC-3008

Document No.




SHIMADZU GAS CHROMATOGRAPH SYSTEM
GC-2010 Series

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.
Signature Date
Print / /
Title

Performer
Company


The undersigned reviewer and manager report that the performer has completed the Operational Qualification Protocol
successfully.

Signature Date
Print / /
Title

Reviewer
Company


Signature Date
Print / /
Title

Manager
Company





Rev. 3.00 Page 2 of 37
Operation Qualification 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 Designation and Recording of Reviewer ........................................................................................ 6
2-2 Performer Identification & Approval ................................................................................................ 7
2-3 Planning Items to be Evaluated in Operational Qualification.......................................................... 9
2-4 Calibration Certification and Instruments Used ............................................................................ 14
2-5 Other Tools Used ......................................................................................................................... 16
3. OPERATIONAL QUALIFICATION RECORD................................................................................... 17
4. CHANGE LIST.................................................................................................................................. 34
5. ATTACHED DOCUMENTS............................................................................................................... 37
Table of Contents

Rev. 3.00 Page 3 of 37
Operation Qualification Definitions

1. Definitions
1-1 Documentation
1. The purpose of this document is to record the results of the Operational Qualification (OQ) implemented on
the Shimadzu Gas Chromatograph GC-2010. If the inspections pass the criteria and the results have been
approved, it has been verified that the instruments operate properly in accordance with their 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 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 GC system being inspected. As well as
verifying the contents of the Installation Qualification Protocol and Operational Qualification Protocol
documentation, the Manager shall also grant final approval to the inspection procedures.

3. The Performer shall check each instrument 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 inspecting all items and checking
their results, 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 contents of this document. After all inspections in the Operational
Qualification Protocol have been implemented, the Manager shall check their results. The Manager shall then
enter a unique document control No. in the Document No. column 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, 4.
Change List and 5. 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.



Rev. 3.00 Page 4 of 37
Operational Qualification Definitions

1-2 Scope

This Operational Qualification shall apply to the equipment installed at the following site.

(Address):

(Company):

(Department):

(Installation Site):

(Equipment ID No.):

(Product Model Name)



































Performer (signature): Date: / /
Reviewer (signature): Date: / /


Rev. 3.00 Page 5 of 37
Operational Qualification Definitions

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, except Remarks columns, are completed, and that there are no omissions.Draw a
diagonal line (from bottom left to top right) across all blank columns.
(When making no entries, it is not necessary to enter the Change List No.__, Date or Signature,or to
enter the reason for the change in the Change List of this document.)
Columns in which nothing has to be written in has been filled in with N/A in advance.
If choices are available within an item, place a checkmark in the box to select the appropriate decision.

2. Rounding of numeric values
If there are more significant figures in the measurement results than the pass criteria, round off the final
answer to bring it in line with the number of figures required for the pass criteria. For example, if the pass
criterion is defined down to 0.1, but the answer is given down to 0.01, round off the answer.

3. Deletion and correction of mistakenly filled items
To correct mistaken entries such as inspection results, 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 re-write the entry. Moreover, write the date, and the signature, and
the reason for the change. (When deletion and correction of mistakenly filled items, it is not necessary to enter
the Change List No.__, Date or Signature, or to enter the reason for the change in the Change List of
this document.)

4. Changing or deleting steps, procedures or acceptance criteria
If there are parts of the steps or procedures which will not be applied, draw a diagonal line through the entire
item and write Change List No. __ above the line and assign a number to it. Date and sign it. Enter the
necessary information in the Change List of this document.
When making a change, delete the existing description as explained above, enter the change point, and then
write down the reason for the change in the Change List.

5. Revising entries
If the need to alter the contents of an entry arises, change the entry in accordance with 3. Deletion and
correction of mistakenly filled items, and then write the reason for the change in the Change List of this
document.
When adding a new description, write it in the margins of the relevant page, and write Change List No. _,
the date and signature. Then, write the reason for the change in the Change List.

6. Handling problems
Any problems identified in 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 box
and describe the problem in the margins of the relevant page. Write Change List No. _ and date and sign
the entry. Enter an outline of the problem in the Change List.
After the problem is solved, describe the solution and the result (Pass) in the margins of the relevant page.
Write Change List No.__ and date and sign the entry. Enter the summary of the solution in the Change List
of this document. If necessary, pages can be added. To add a page, record the Change List No. on the
page and date/ sign it. Add an alphabetical letter (starting from A) to the page number (e.g., 5-A), and insert
the added page after the relevant page. Add the page number of the added page to the Table of Contents and
record it in the Change List.

8. 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 37-A-1/3 - A-3/3, ensuring that no numbers
are omitted. The Performer shall date and sign the attached data.

9. Other
Every item entered into the Change List shall be approved by the Reviewer and Manager.

Rev. 3.00 Page 6 of 37
Operational Qualification Preliminary Checks

2. Preliminary Checks
2-1 Designation and Recording of Reviewer
Before conducting this inspection, enter the name of the Reviewer designated by the Manager.


Reviewer

Name:

Title: 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:

Title: Date: / /

Reviewer 3 (Not applicable)

Name:

Title: Date: / /



Rev. 3.00 Page 7 of 37
Operational Qualification Preliminary Checks

2-2 Performer Identification & Approval
Identify and approve the Performer. Choose the entry section according to the way in which the Performer is
selected.

If the Performer is a service technician authorized by Shimadzu Corporation, complete the following.

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 qualified IQ/OQ Inspector, as proven by the
certificate. The person performs the Installation Qualification Protocol as the Performer.
Performer
Name:
Title:
Company name:
Certificate No.:
Signature:


Date: / /

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:
Title:
Company name:
Certificate No.:
Signature:


Date: / /
Performer 3 (Not applicable)
Name:
Title:
Company name:
Certificate No.:
Signature:


Date: / /

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:
Manager
Signature:


Date: / /


Date: / /


Rev. 3.00 Page 8 of 37
Operational Qualification Preliminary Checks

If the Performer has been appointed by the Manager, complete the following.
Performer
Name:
Title:
Company name:
Signature:


Date: / /




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
Signature:
Manager
Signature:


Date: / /


Date: / /



Rev. 3.00 Page 9 of 37
Operational Qualification Preliminary Checks

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.

2-3-1 Checking Equipment Configuration
The units and special 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 page.
<Equipment Configuration>

Applicable
Not
Applicable
Model Name
Gas Chromatograph
GC-2010A
Auto Injector
AOC-20i
AOC-20i without power supply
Auto Sampler
AOC-20s
Injection Unit
SPL-2010 (Addition)
WBI-2010
OCI/PTV-2010
Detector
FID-2010 (Addition 1)
FID-2010 (Addition 2)
FID-2010 (Addition 3)
FTD-2010 (Addition 1)
FTD-2010 (Addition 2)
FPD-2010
ECD-2010 (Addition 1)
ECD-2010 (Addition 2)
ECD-2010 (Addition 3)
ECD-2010 (Addition 4)
Data processing unit
Computer
GCsolution
CLASS-Agent
C-R7A plus
C-R8A
Other options
FLM-2/FLM-17




We hereby approve the system configuration specified above.
Performer (signature): Date: / /
Reviewer (signature): Date: / /

Rev. 3.00 Page 10 of 37
Operational Qualification Preliminary Checks

2-3-2 Planning Component Evaluation Items
Prior to implementing this operational qualification, confirm which items to be evaluated for components
comprising the system. Place a checkmark in the Applicable box for items to be evaluated, and Not
Applicable for items not to be evaluated. Enter a diagonal line in the Pass/Fail checkbox for Not applicable
items.

1. GC-2010 Gas Chromatograph
No. Item Outline Applicable
Not
applicable
1 Display/LED Test Verify the operation of displays and LEDs
2 Standard Self-diagnostic Test Verify. the status and operation of all parts
3 Firmware Verification Verify the version number of software
4 Temperature Test Verify that the temperature control is normal
5 Column Inlet Pressure Test Verify the accuracy of the column inlet pressure
6 Column Inlet Pressure Test Verify the function of the column inlet pressure program.
7 Flow Rate Accuracy Test Verify the flow rate accuracy of full-flow and septum purging.
8 Column Oven Test Verify the accuracy of the column oven temperature.
9 Temperature Program Test Verify the function of the column temperature program.
10 Sensitivity Test Verify the detector sensitivity.

2. AOC-20i Auto Injector Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Display, LED Test Verify the display and LED operation.
2 ROM,RAM self-diagnostic Test Verify that ROM and RAM memory operates normally.
3 Firmware Verification Verify the program version.
4 Basic operation test Verify that the auto injector basic operation is correct.

3. AOC-20s Auto Sampler Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Initial Operation Test Verify that the auto sampler basic operation is correct.
2 Firmware Version Check Verify the program version.

4. SPL-2010 Split/Splitless Injection unit Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Column Inlet Pressure Test Verify the accuracy of the column inlet pressure.
2 Pressure Program Test Verify that the pressure program operates normally.
3 Flow Rate Test Verify the accuracy of the full-flow and septum purging.

5. WBI-2010 Direct Injection Unit Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Column Inlet Pressure Test Verify the accuracy of the column inlet pressure
2 Pressure Program Test Verify that the pressure program operates normally
3 Flow Rate Test Verify the total flow rate and septum purge accuracy

6. OCI/PTV-2010 On-column/Programmable Temperature Injection Unit
Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Temperature Test Verify that temperature control is normal.
2 Column Inlet Pressure Test Verify the accuracy of the column inlet pressure.
3 Pressure Program Test Verify that the pressure program operates normally.
4 Flow Rate Test Verify the accuracy of the full-flow and septum purging.



Rev. 3.00 Page 11 of 37
Operational Qualification Preliminary Checks

7. FID-2010 Flame Ionization Detector Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Sensitivity test Verify the detector sensitivity.

8. FTD-2010 Flame Thermionic Detector Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Sensitivity test Verify the detector sensitivity.

9. FPD-2010 Flame Photometric Detector Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Sensitivity test Verify the detector sensitivity.

10. ECD-2010 Electron Capture Detector Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Sensitivity test Verify the detector sensitivity.

11. FLM-2/FLM-17 Flame Warning Unit Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Basic Operation Test Verify that the basic operation is correct..

12. Data Processing Unit GCsolution/CLASS-Agent Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
Personal Computer
1-1 Computer boot-up test Checks that the computer boots up and runs normally.
1-2 Time and date check Checks that the PC time and date are correct.
1-3 Hard disk drive test Checks that the hard disk operates correctly.
1-4 Print driver check Checks the print driver test page and the version number.
1-5 Network connection test Checks that the network connection is normal.
GCsolution
2-1 Software version check
Checks that the software is not changed to an inappropriate
version.

2-2 Program alteration check Conducts the program alteration check.
2-3
Shimadzu User Authentication
Tool connection check
Checks the Shimadzu User Authentication Tool connection
using database access and log registration. (This test is
conducted only if the Shimadzu User Authentication Tool is
used with GCsolution.)

2-4 Security function tests
Checks that the security functions operate, including
restrictions on the number of password characters.

2-4-1
Password log management
function check
Checks that a duplicated password cannot be used.
2-4-2
Number of password characters
check
Checks that the restriction on the minimum number of
password operates.

2-4-3 Failed login detection Confirms that a failed login is detected.
2-4-4 User lockout function check
Confirms that a user is locked out when the designated number
of login failures is exceeded.

2-4-5 Failed login log Confirms that a failed login attempt is registered in the log.
2-5 User access rights check
Confirms that software use is restricted according to
differences in registered user access rights.

2-6 System policy function check Checks the GCsolution system policy function.
2-7 Audit trail check Checks the audit trail functions.
2-8 Screen lock function check Checks the screen lock function.
2-9
Test of function to prevent
duplicate user registration
Confirms that a duplicate user name cannot be registered.

Rev. 3.00 Page 12 of 37
Operational Qualification Preliminary Checks


No. Item Outline Applicable
Not
applicable
2-10 Software function checks
Checks the GCsolution peak integration, peak identification
from retention times, quantitative calculations using peak areas
and peak heights, column performance parameter calculations
for each Pharmacopoeia, and the output of data information,
calibration curve information, and set parameters.

2-10-1 Peak integration Checks the peak integration functions.
2-10-2 Peak area percentage method
Checks the quantitation calculation functions using the peak
area percentage method.

2-10-3 Internal standard method
Checks the quantitation calculation functions using the internal
standard method.

2-10-4 External standard method
Checks the quantitation calculation functions using the external
standard method.

CLASS-Agent
3-1 Software version check
Checks that the software is not changed to an inappropriate
version.

3-2 Program alteration check Conducts the program alteration check.
3-3
Shimadzu User Authentication
Tool connection check
Checks the Shimadzu User Authentication Tool connection
using database access and log registration.

3-4 Security function tests
Checks that the security functions operate, including
restrictions on the number of password characters.

3-4-1
Password log management
function check
Checks that a duplicated password cannot be used.
3-4-2
Number of password characters
check
Checks that the restriction on the minimum number of
password operates.

3-4-3 Failed login detection Confirms that a failed login is detected.
3-4-4 User lockout function check
Confirms that a user is locked out when the designated number
of login failures is exceeded.

3-4-5 Failed login log Confirms that a failed login attempt is registered in the log.
3-5 User access rights check
Confirms that software use is restricted according to
differences in registered user access rights.

3-6
Test of function to prevent
duplicate user registration
Confirms that a duplicate user name cannot be registered.
3-7 Data display, search, and sort
Checks that the sample search and sort work correctly and that
the data is displayed normally.

3-8 Data recovery
Checks that the data files registered in a database can be
correctly recovered.

GCsolution automatic registration
4
GCsolution automatic
registration function check
(Data integrity check)
Checks that correct data is registered by GCsolution automatic
registration to the database.

GCsolution manual registration
5
GCsolution manual registration
function check
Checks that correct data is registered by GCsolution manual
registration to the database.

Electronic signature
6 Electronic signature check
Checks the CLASS-Agent Manager electronic signature
function.

System log
7 System log recording check
Checks that the changes to the CLASS-Agent Manager system
setting conditions are recorded to the system log.


4. Data Processing Unit Chromatopac C-R7A plus/C-R7Ae plus/C-R8A
Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Memory self-diagnostic test
Checks that the result of the ROM/RAM self-diagnostic check is
normal.

2-1 Zero point Checks the measured voltage value at 0 V analog input.
2-2 Span Checks the measured voltage value at 1 V analog input.
2-3 Zeroing
Checks the difference between measured voltage values in two
measuring ranges.

2-4 Linearity Checks the linearity between 0 V and 1 V input voltages.
2-5 Slope test Slope test at fixed input voltage (0 V).
2-6 Accuracy Checks the accuracies for peak area, height, and retention time.
2-7 Range
Checks the range (discrepancy from maximum to minimum) for
peak area, height, and retention time.

2-8 Repeatability
Checks the repeatability (coefficient of variance) for peak area,
height, and retention time.



Rev. 3.00 Page 13 of 37
Operational Qualification Preliminary Checks

2-3-3 Planning System Evaluation Items
Prior to implementing this operational qualification, confirm which items to be evaluated for the system. Place a
checkmark in the Applicable box for items to be evaluated, and Not Applicable for items not to be evaluated.
Enter a diagonal line in the Pass/Fail checkbox for Not applicable items.

1. GC-2010 Analysis System Applicable Not Applicable

No. Item Outline Applicable
Not
applicable
1 Repeatability tests Verify the repeatability for the peak area and retention time.























Execution purpose of this Qualification

New installation Periodic check Component addition Repair

Others( )



We hereby approve that the Operational Qualification will be implemented by evaluating the items specified in
section 2-3 of this document.
Performer (signature): Date: / /
Reviewer (signature): Date: / /

Rev. 3.00 Page 14 of 37
Operational Qualification Preliminary Checks

2-4 Calibration Certification and Instruments Used
The instruments and reagents used in the inspections are listed below.
When instruments controlled by the Shimadzu service company are to be used, copies of the Certificate of
Traceability and the Quality Assurance sheet will be submitted. However, if the assured performance satisfies the
required specifications, calibrated instruments controlled by the customer may be used in the inspections.

(1) Items prepared by the Shimadzu Service Company

(1) Instruments for which the traceability certificate will be submitted
Certificates of traceability are attached to the following instruments controlled by the Shimadzu service
company.

* Pressure gauge
For the assured performance specifications of the pressure gauge used to measure the column inlet pressure
accuracy and for the pressure program operational check, a precision of 6 kPa shall be required in the pressure
range (200 kPa and 250 kPa) required for the equipment inspections.
Instrument name: Digital pressure gauge ; Model: POP-612 Control No:
Inspection date: Expiry date:
Instrument name: Digital pressure gauge ; Model: MT10 Control No:
Inspection date: Expiry date:
Instrument name: ; Model Control No:
Inspection date: Expiry date:
* Flow meter
For the assured performance specifications of the flow meter used for the full-flow and septum purge accuracy
checks and for TCD sensitivity measurements, a precision of 3% shall be required in the flow rate range (3,
20, and 200 mL/min) required for the equipment inspections.
Instrument name: Precision membrane flow meter; Model: SF-1 Control No:
Inspection date: Expiry date:
Instrument name: Digital flow meter ; Model: DFM-1000 Control No:
Inspection date: Expiry date:
Instrument name: ; Model Control No:
Inspection date: Expiry date:
* Digital temperature indicator
For the assured performance specifications of the recorder used to measure the column oven temperature accuracy,
a precision of 0.5C shall be required at the 150C temperature required for the equipment inspections.
Instrument name: Hybrid recorder ; Model: RD2212 Control No:
Inspection date: Expiry date:
Instrument name: Digital thermometer ; Model:ND522-3LP Control No:
Inspection date: Expiry date:
Instrument name: ; Model Control No:
Inspection date: Expiry date:
* Resistance temperature sensor
For the assured performance specifications of the resistance temperature sensor used to measure the column
oven temperature accuracy, a precision of 0.5C shall be required in the temperature range (150 C) required
for the equipment inspections.
Instrument name: Sheathed resistance temperature sensor; NRHS1-0 Control No:
Inspection date: Expiry date:
Instrument name: ; Model Control No:
Inspection date: Expiry date:

Rev. 3.00 Page 15 of 37
Operational Qualification Preliminary Checks


* Thermocouple
For the assured performance specifications of the thermocouple used to measure the column oven temperature
accuracy, a precision rating of 0.6C shall be required in the temperature range (150 C) required for the
equipment inspections.
Instrument name: K-sheath thermocouple ; Model: SCH S1-0 Control No:
Inspection date: Expiry date:
Instrument name: ; Model Control No:
Inspection date: Expiry date:

* DC voltage/current generator
The DC voltage/current generator used for the Chromatopac Hardware Validation check shall have a precision
rating of 0.15% at the test point as a guaranteed performance specification.
Instrument name: ; Model: R6142 Control No:
Programmable DC voltage/current generator
Inspection date: Expiry date:
Instrument name: ; Model Control No:
Inspection date: Expiry date:

(2) Instrument/reagents whose Quality Assurance sheet is submitted upon request
For the following equipment and reagents, the quality assurance sheet can be submitted upon request from a
customer.
* Standard reagents for performance inspection
n-C
12, 14, 16
/n-heptane solution 100ng/L 2mL x 5 Ampoules221-44247-08
For the detector sensitivity test and the system repeatability test of FID
Lot No.: Expires:
n-decane/n-hexane solution 1000ng/L 2mL x 5 Ampoules221-44247-11
For the detector sensitivity test and system repeatability test of TCD
Lot No.: Expires:
Azobenzene/n-hexane solution 1ng/L 2mL x 5 Ampoules221-44247-07
For the detector sensitivity test and the system repeatability test of FTD (N compounds)
Lot No.: Expires:
Malathion/n-hexane solution 100pg/L 2mL x 5 Ampoules221-44247-14
For the detector sensitivity test and the system repeatability test of FTD (P compounds)
Lot No.: Expires:
Tributyl phosphate/n-hexane solution 1ng/L 2mL x 5 Ampoules221-44247-15
For the detector sensitivity test and the system repeatability test of FTD (P compounds)
Lot No.: Expires:
Tributyl phosphate/n-hexane solution 10ng/L 2mL x 5 Ampoules221-44247-12
For the detector sensitivity test and the system repeatability test of FPD (P compounds)
Lot No.: Expires:
Dodecanethiol/n-hexane solution 10ng/L 2mL x 5 Ampoules221-44247-13
For the detector sensitivity test and the system repeatability test of FPD (S compounds)
Lot No.: Expires:
-BHC/n-hexane solution 0.1ng/L 2mL x 5 Ampoules221-44247-03
For the detector sensitivity test and the system repeatability test of ECD
Lot No.: Expires:


Rev. 3.00 Page 16 of 37
Operational Qualification Preliminary Checks

2-5 Other Tools Used
Tools, solvents, etc. used in this inspection are shown below.
These are classed as customer-supplied items or Shimadzu service company-supplied items.


(1) Items prepared by the customer

* Carrier gas
* Detector gas
* Hexane
* Glass insert for split [221-41444-01] ; when using SPL for inspection
* Glass insert for splitless, WBI [221-48335-01] ; when using WBI for inspection

(2) Items prepared by the Shimadzu Service Company
* Devices
Glass vial 1.5mL [221-34272-92] ; for AOC-20i/s
Vial cap 1.5mL [221-34273-92] ; for AOC-20i/s
Vial septum 1.5mL [221-41239-91] ; for AOC-20i/s
Glass vial 4 mL [221-34267-92] ; for AOC-20i/s
Vial cap 4 mL [221-34268-92] ; for AOC-20i/s
Vial septum 4 mL [221-34266-92] ; for AOC-20i/s

Columns (To test GC unit. Select from following four types.)
CBP1-M25-025 [221-28635-25] ; for sensitivity, repeatability tests
DB-1-30N-STD [J&W P/N122-1032] ; for sensitivity, repeatability tests
ZB-1 (30m x 0.25mmID, 0.25 m) ; for sensitivity, repeatability tests
Rtx-1 (30m x 0.25mmID, 0.25 m) ; for sensitivity, repeatability tests

Columns (For OCI/PTV temperature test; for sensitivity test and system check using WBI. Select from
following two types.)
CBP1-W12-100 [221-28647-12] for OCI/PTV and WBI tests
DB-1-15M-STD [J&W P/N125-1032] for OCI/PTV and WBI tests

Pressure measurement adaptor [221-42686-91] ; for pressure test
Pipe MF-MF [201-48555-**] ; to connect adapter and pressure gauge
Column holder [221-31567-91] ; to fix temperature sensor
Microsyringe MS-G10AC [221-45169-01] ; for manual injection
Microsyringe (CAL)10F-RA6 [221-45170-01] ; for manual injection

* Others
Vulcanized tape [018-21330] for pressure measurement adapter
Cable [223-06064-90] to connect voltage / current generator





The equipment, reagents, tools, and misc. items described in Sections 2.4 and 2.5 are approved for use in the
inspections.
Performer (signature): Date: / /
Reviewer (signature): Date: / /

Rev. 3.00 Page 17 of 37
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.
Here, Inspection results are recorded along the procedure of Chapter 4 in Operational Qualification Protocol.

3-1 Gas Chromatograph GC-2010 Applicable Not Applicable
Model Name GC-2010
Component ID

Serial Number (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results Pass Fail
All LEDs light. LED


1
Display, LED
test
Verify the
display and
LED
operation.
Screen contrast adjustment is
possible.
Display


2
Standard
self-diagnostic
test
Verify the
status and
operation of
all parts.
"Good" displayed as the result of the
self-diagnostic test.


Version: Version number and build number
are displayed.
Ver.
Build No.:
Version:
3
Firmware
version check
Verify the
program
version.
The version No. and build No.
matches the controlled version
number.
Controled
Ver. No.
Build No.:

TEMP LED lights green.
Temperature
controller
(Name)
Set value Measured
value
COL __ __.__C __ __.__C
INJ1 __ __.__C __ __.__C
INJ2 __ __.__C __ __.__C
DET1 __ __.__C __ __.__C
DET2 __ __.__C __ __.__C
AUX3 __ __.__C __ __.__C
AUX4 __ __.__C __ __.__C
4
Temperature
test
Verify that
temperature
control is
normal.
Displayed
actual values
agree to the
set values
within 1C.
AUX5 __ __.__C __ __.__C

Pressure gauge
correction value
__.__Pa
Pressure gauge reading __ __.__Pa
Inspection pressure gauge
reading
10.0 3.0Pa
Post-correction reading __ __.__Pa
Pressure gauge
correction value
__.__Pa
Pressure gauge reading __ __ __.__Pa
Inspection pressure gauge
reading
200.0 20.0Pa
Post-correction reading __ __ __.__Pa
Pressure gauge
correction value
__.__Pa
Pressure gauge reading __ __ __.__Pa
5
Column inlet
pressure test
Verify the
accuracy of
the column
inlet pressure.
Inspection pressure gauge
reading
500.0 35.0Pa
Post-correction reading __ __ __.__Pa



Performer (signature): Date: / /
Reviewer (signature): Date: / /


Rev. 3.00 Page 18 of 37
Operational Qualification Operational Qualification Record

No. Item Criteria Results Pass Fail
Monitored pressure 6 minutes after start
250.0 5.0 kPa
__ __ __.__Pa
6
Pressure
program test
Verify that the
pressure
program
operates
normally.
Inspection pressure gauge reading 8 minutes after start
250.0 20.0 kPa
__ __ __.__Pa

Septum purge vent measured flow rate
3.0 1.0mL/min
Septum purge
__.__ mL/min

Split vent
______. __mL/min
Total of septum purge and split vent flow rate values
10.0 3.0mL/min
Total
______. __mL/min
Split vent
_________mL/min
Total of septum purge and split vent flow rate values
200 20mL/min
Total

_________mL/min
Split vent
_________mL/min
7
Flowrate test Verify the
accuracy of
the full-flow
and septum
purging.
Total of septum purge and split vent flow rate values
500 35mL/min
Total

_________mL/min

Temp. correction value __.__C
Temp. sensor reading ___ __.__C
Inspection temperature
sensor displayed value
50.03.2
Corrected temp. value ___ __.__C
Temp. correction value __.__C
Temp. sensor reading __ __ __.__C
Inspection temperature
sensor displayed value
150.04.2
Corrected temp. value __ __ __.__C
Temp. correction value __.__C
Temp. sensor reading __ __ __.__C
8
Column oven
test
Verify the
accuracy of
the column
oven
temperature.
Inspection temperature
sensor displayed value
280.05.7
2804
Corrected temp. value __ __ __.__C

Monitored temperature 6 minutes after start 200 1C

__ __ __C
Inspection temperature reading 8 minutes after start
200.0 4.7C
__ __ __.__C 9
Temperature
program test
Verify that the
column
temperature
program
operates
normally.
Using a temperature sensor with 1C minimum
display increment 200 3C
__ __ __C

C
16
AREA value

Vs
FID ( Applicable
Not Applicable)
Calculated S value
Inj. unit ( )
Make-up gas: N
2

10.0 x 10
-3
C/g min.
Make-up gas: He
7.00 x 10
-3
C/g min.
Calculated S
value
__ __.__ __x10
-3
C/g

C
10
AREA value
Vs
Flowrate at vent
__ __.__ __mL/min
10
Sensitivity
test

Verify the
detector
sensitivity.
TCD ( Applicable
Not Applicable)
Calculated S value
Inj. unit ( )
4.00 x 10
3
mVml/mg min.
Calculated S
value
__ __.__ __x10
3
V
mL/mg



Performer (signature): Date: / /
Reviewer (signature): Date: / /


Rev. 3.00 Page 19 of 37
Operational Qualification Operational Qualification Record

3-2 AOC-20i Auto Injector Applicable Not Applicable

Single Dual system, main injector

Model Name AOC-20i
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results
Pass Fail
1
Display, LED
test
Verify the display and LED
operation.
All LEDs light, except decimal point.

2
ROM RAM
self diagnosis
Verify that ROM and RAM
memory operates normally.
Display shows "000". Display:

Version number is displayed.
Version
No.

3
Firmware
version check
Verify the
program
version.
The version number matches the
controlled version number.
Controled
Ver. No.


4
Basic
operation test
Verify that the auto
injector basic operation is
correct.
Sample injected into the GC and GC
operation starts.




Not Applicable Dual system, sub injector

Model Name AOC-20i
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results
Pass Fail
1
Display, LED
test
Verify the display and LED
operation.
All LEDs light, except decimal point.

2
ROM RAM
self diagnosis
Verify that ROM and RAM
memory operates normally.
Display shows "000". Display:

Version number is displayed. Version No.
3
Firmware
version check
Verify the
program
version.
The version number matches the
controlled version number.
Controled
Ver. No.


4
Basic
operation test
Verify that the auto injector
basic operation is correct.
Sample No.1 transferred to the main
injector, sample No. 2 transferred to the
sub-injector.
Sub-injector injects into the GC
simultaneously with the main AOC.







Performer (signature): Date: / /
Reviewer (signature): Date: / /



Rev. 3.00 Page 20 of 37
Operational Qualification Operational Qualification Record


3-3 AOC-20s Auto Sampler Applicable Not Applicable

Model Name AOC-20s
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results
Pass Fail
1
Initial
operation test
Verify that the auto sampler basic
operation is correct.

LED lights green, not red.

Version number is displayed. Version No.
2
Firmware
version check
Verify the
program
version.
The version number matches the
controlled version number.
Controled
Ver. No.

































Performer (signature): Date: / /
Reviewer (signature): Date: / /



Rev. 3.00 Page 21 of 37
Operational Qualification Operational Qualification Record

3-4 SPL-2010 Split/Splitless Injection Unit Applicable Not Applicable

Model Name SPL-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results Pass Fail
Pressure gauge correction
value
__.__Pa
Pressure gauge reading __ __.__Pa
Inspection pressure gauge
reading
10.0 3.0Pa
Post-correction reading __ __.__Pa
Pressure gauge correction
value
__.__Pa
Pressure gauge reading __ __ __.__Pa
Inspection pressure gauge
reading
200.020.0Pa
Post-correction reading __ __ __.__Pa
Pressure gauge correction
value
__.__Pa
Pressure gauge reading __ __ __.__Pa
1
Column
inlet
pressure
test
Verify the
accuracy of the
column inlet
pressure.
Inspection pressure gauge
reading
500.035.0Pa
Post-correction reading __ __ __.__Pa

Monitored pressure 6 minutes after start
250.0 5.0 kPa
__ __ __.__Pa
2
Pressure
program
test
Verify that the
pressure
program
operates
normally.
Inspection pressure gauge reading 8 minutes after start
250.0 20.0 kPa
__ __ __.__Pa

Septum purge vent measured flow rate
3.01.0mL/min
Septum purge
__.___mL/min

Split vent
__.__ mL/min
Total of septum purge and split vent flow rate values
10.03.0mL/min
Total
____. __mL/min
Split vent
________mL/min Total of septum purge and split vent flow rate values
20020mL/min Total
________mL/min
Split vent
________mL/min
3
Flowrate
test
Verify the
accuracy of the
full-flow and
septum
purging.
Total of septum purge and split vent flow rate values
50035mL/min Total
________mL/min












Performer (signature): Date: / /
Reviewer (signature): Date: / /



Rev. 3.00 Page 22 of 37
Operational Qualification Operational Qualification Record


3-5 WBI-2010 Direct Injection Unit Applicable Not Applicable

Model Name WBI-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results Pass Fail
Pressure gauge correction
value
__.__Pa
Pressure gauge reading __ __.__Pa
Inspection pressure
gauge reading
10.0 3.0Pa
Post-correction reading __ __.__Pa
Pressure gauge correction
value
__.__Pa
Pressure gauge reading __ __.__Pa
Inspection pressure
gauge reading
50.0 10.0Pa
Post-correction reading __ __.__Pa
Pressure gauge correction
value
__.__Pa
Pressure gauge reading __ __ __.__Pa
1
Column
inlet
pressure
test
Verify the
accuracy of the
column inlet
pressure.
Inspection pressure
gauge reading
200.020.0Pa
Post-correction reading __ __ __.__Pa

Monitored pressure 6 minutes after start
250.0 5.0 kPa
__ __ __.__Pa
2
Pressure
program
test
Verify that the
pressure program
operates
normally.
Inspection pressure gauge reading 8 minutes after start
250.0 20.0 kPa
__ __ __.__Pa

Septum purge vent measured flow rate
3.0 1.0mL/min
Septum purge
__.__ mL/min

Column outlet measured flow rate 5.0 1.5mL/min
Measured flow
__.__ mL/min
Column outlet measured flow rate 20.0 5.0mL/min
Measured flow
____. __mL/min
3
Flowrate
test
Verify total flow
(column outlet
flow) and septum
purge accuracy.
Column outlet measured flow rate 100 15mL/min
Measured flow
______mL/min












Performer (signature): Date: / /
Reviewer (signature): Date: / /



Rev. 3.00 Page 23 of 37
Operational Qualification Operational Qualification Record

3-6 OCI/PTV-2010 On-column/Programmable Temperature Injection Unit
Applicable Not Applicable

Model Name OCI/PTV-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results Pass Fail
Measured temperature value displayed immediately
after start: 50 5C
__ __.__
Measured temperature value displayed 8 minutes after
start: 250 5C
__ __ __.__
1
Temperature
test
Verify that
temperature
control is
normal.
Fan operation begins 10 minutes after start.
Pressure gauge correction
value
__.__Pa
Pressure gauge reading __ __.__Pa
Inspection pressure gauge
reading
10.0 3.0Pa
Post-correction reading __ __.__Pa
Pressure gauge correction
value
__.__Pa
Pressure gauge reading __ __.__Pa
Inspection pressure gauge
reading
50.0 10.0Pa
Post-correction reading __ __.__Pa
Pressure gauge correction
value
__.__Pa
Pressure gauge reading __ __ __.__Pa
Inspection pressure gauge
reading
200.0 20.0Pa
Post-correction reading __ __ __.__Pa
Pressure gauge correction
value
__.__Pa
Pressure gauge reading __ __ __.__Pa
2
Column inlet
pressure test
Verify
column inlet
pressure
accuracy.
Inspection pressure gauge
reading
500.0 35.0Pa
Post-correction reading __ __ __.__Pa

Monitored pressure 6 minutes after start
250.0 5.0 kPa
__ __ __.__Pa
3
Pressure
program test
Verify that
the pressure
program
operates
normally.
Inspection pressure gauge reading 8 minutes after start
250.0 20.0 kPa
__ __ __.__Pa

Septum purge vent measured flow rate
3.00 1.00mL/min
Septum purge
__.___mL/min

Split vent
__.__ mL/min
Total of septum purge and split vent flow rate values
10.0 3.0mL/min
Total
____. __mL/min
Split vent
_________mL/min Total of septum purge and split vent flow rate values
200 20mL/min Total
__________mL/min
Split vent
_________mL/min
4
Flow rate test
Used for
OCI, so not
conducted.
Verify
accuracy of
total flow
and septum
purge.
Total of septum purge and split vent flow rate values
500 35mL/min Total
_________mL/min




Performer (signature): Date: / /
Reviewer (signature): Date: / /



Rev. 3.00 Page 24 of 37
Operational Qualification Operational Qualification Record

3-7 FID-2010 Flame Ionization Detector Applicable Not Applicable
Addition 1
Model Name FID-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results Pass Fail
C
16
AREA value
Vs
1
Sensitivity
test

Injection unit
( )
Verify detector
sensitivity
Sensitivity S calculated
value
Make-up gasN
2

10.0x10
-3
C/g
Make-up gasHe
7.00x10
-3
C/g
Sensitivity S
calculated value
__ __.__ __x10
-3
C/g




Addition 2 Applicable Not Applicable
Model Name FID-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results Pass Fail
C
16
AREA value
Vs
1
Sensitivity
test

Injection unit
( )
Verify detector
sensitivity
Sensitivity S calculated
value
Make-up gasN
2

10.0x10
-3
C/g
Make-up gasHe
7.00x10
-3
C/g
Sensitivity S
calculated value
__ __.__ __x10
-3
C/g




Addition 3 Applicable Not Applicable
Model Name FID-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results Pass Fail
C
16
AREA value
Vs
1
Sensitivity
test

Injection unit
( )
Verify detector
sensitivity
Sensitivity S calculated
value
Make-up gasN
2

10.0x10
-3
C/g
Make-up gasHe
7.00x10
-3
C/g
Sensitivity S
calculated value
__ __.__ __x10
-3
C/g





Performer (signature): Date: / /
Reviewer (signature): Date: / /



Rev. 3.00 Page 25 of 37
Operational Qualification Operational Qualification Record

3-8 FTD-2010 Flame Thermionic Detector Applicable Not Applicable

Addition 1
Model Name FTD-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results
Pass Fail
AREA value
Vs
N (Applicable N/A)
Azobenzen MDQ
2.00 x 10
-12
gN/s
MDQ __.__ __ x 10
-12
gN/s

AREA value
Vs
1
Sensitivity
test

Injection unit
( )
Verify the
detector
sensitivity.
P (Applicable N/A)
Malathion
Tributyl phosphate
MDQ 0.900 x 10
-12

gP/s
MDQ __.__ __ __ x 10
-12
gP/s


Addition 2 Applicable Not Applicable
Model Name FTD-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results
Pass Fail
AREA value
Vs
N (Applicable N/A)
Azobenzen MDQ
2.00 x 10
-12
gN/s
MDQ __.__ __ x 10
-12
gN/s

AREA value
Vs
1
Sensitivity
test

Injection unit
( )
Verify the
detector
sensitivity.
P (Applicable N/A)
Malathion
Tributyl phosphate
MDQ 0.900 x 10
-12

gP/s
MDQ __.__ __ __ x 10
-12
gP/s











Performer (signature): Date: / /
Reviewer (signature): Date: / /



Rev. 3.00 Page 26 of 37
Operational Qualification Operational Qualification Record

3-9 FPD-2010 Flame Photometric Detector Applicable Not Applicable

Model Name FPD-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results
Pass Fail
AREA value
Vs
S (Applicable N/A)
Dodecane thiol MDQ
40.0 x 10
-12
gS/s
MDQ __ __.__ x 10
-12
gS/s

AREA value
Vs
1
Sensitivity
test

Injection unit
( )
Verify the
detector
sensitivity.
P (Applicable N/A)
Tributyl phosphate MDQ
2.00x10
-12
gP/s
MDQ __.__ __ x 10
-12
gP/s


3-10 ECD-2010 Electron Capture Detector Applicable Not Applicable
Addition 1
Model Name ECD-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results
Pass Fail
AREA value Vs
1
Sensitivity
test

Injection unit
( )
Verify the
detector
sensitivity.
-BHC MDQ 80.0 x
10
-15
g/s
MDQ __ __.__ x 10
-1
g/s


Addition 2 Applicable Not Applicable
Model Name ECD-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results
Pass Fail
AREA value Vs
1
Sensitivity
test

Injection unit
( )
Verify the
detector
sensitivity.
-BHC MDQ 80.0 x
10
-15
g/s
MDQ __ __.__ x 10
-1
g/s



Performer (signature): Date: / /
Reviewer (signature): Date: / /



Rev. 3.00 Page 27 of 37
Operational Qualification Operational Qualification Record

Addition 3 Applicable Not Applicable
Model Name ECD-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results
Pass Fail
AREA value Vs
1
Sensitivity
test

Injection unit
( )
Verify the
detector
sensitivity.
-BHC MDQ 80.0 x
10
-15
g/s
MDQ __ __.__ x 10
-1
g/s


Addition 4 Applicable Not Applicable
Model Name ECD-2010
Component ID
Serial No. (S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Results
Pass Fail
AREA value Vs
1
Sensitivity
test

Injection unit
( )
Verify the
detector
sensitivity.
-BHC MDQ 80.0 x
10
-15
g/s
MDQ __ __.__ x 10
-1
g/s



3-11 FLM-2/FLM-17 Flame Warning Unit Applicable Not Applicable

Model Name FLM-2/FLM-17
Component ID
No. Item Criteria Results
Pass Fail
1
Basic
operation test

Verify that the
basic
operation is
correct.
The FLM (amplifier unit) lamp goes out correctly.









Performer (signature): Date: / /
Reviewer (signature): Date: / /



Rev. 3.00 Page 28 of 37
Operational Qualification Operational Qualification Record

3-12 GCsolution /CLASS-Agent Applicable Not Applicable





Performer (signature): Date: / /
Reviewer (signature): Date: / /


Model Name Workstation GCsolution
Serial Number (S/N)

____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Inspection results
Pass Fail
1-1 Computer boot-up test Windows starts up normally.
Computer Basic
/ / / / 1-2 Time and date check
Date and time are correct.
Permitted range


Drive Error detection
C


1-3 Hard disk drive test No error detected for any drive.


Test page printed correctly.
Ver.
1-4 Print driver check
The driver version number
matches the controlled version
number.
Controled Ver.


1-5
Network connection test
Not implemented because
not connected to network
No packets lost.
Designated IP
address



GCsolution Applicable Not Applicable

Ver.
2-1 Software version check
The version number matches the
controlled version number. Control ed Ver.

2-2 Program alteration check OK is displayed for every item.
Server name for the connected
database is correct.
Server name:



Login possible from [View event log].
2-3
Shimadzu Authentication Tool
connection check
Not implemented because not
used with GCsolution
Lockout by GCPrun.exe is registered.
2-4 Security function test
2-4-1
Password log management
function check
Duplicated passwords cannot be used.
2-4-2
Number of password characters
check
A password shorter than the minimum length is not accepted while a
password satisfying the minimum length is accepted.

2-4-3 Failed login detection
Login is not possible with an incorrect password but possible with the
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.

Rev. 3.00 Page 29 of 37
Operational Qualification Operational Qualification Record





Performer (signature): Date: / /
Reviewer (signature): Date: / /

No. Item Criteria Inspection results
Pass Fail
2-5 User access rights check
OQ_USER_2 can edit Instrument Parameters but OQ_USER_1 cannot
edit them.

A check mark appears for the audit trail settings in a newly created
method file.

2-6 System policy function check
Overwriting other method files is prohibited.
2-7 Audit trail check
Audit trail details (Date&Time, Modification, Reason) are displayed
correctly.

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.

2-9
Test of function to prevent
duplicate user registration
A message indicates that This user ID is already registered.
Duplicate user registration is not possible.

2-10 Software function checks Registration to Agent database Database name
Peak tailing is conducted in the "Demo_Data-IT01.gcd" report.
Peak vertical splitting is conducted in the "Demo_Data-IT02.gcd"
report.
2-10-1 Peak integration
Peak baseline processing is conducted in the "Demo_Data-IT03.gcd"
report.

2-10-2 Peak area percentage method The results match.
2-10-3 Internal standard method The results match.
The results match.
Operator name (Acquired by), analysis date (Data Acquired), processed
date (Data Processed), and name of data file (Data File Name) used are
printed as sample information.

Calibration curve information is printed.
2-10-4 External standard method
Unit Parameters and Peak Integration, peak Identification, and
Quantitative parameters and Compound Table are printed.


CLASS-Agent Software Applicable Not Applicable

The version number matches the
controlled version number.
Ver.
Controled
Ver.
CLASS-Agent manager

Shimadzu User Authentication Tool







3-1 Software version check



3-2
Program alteration check
"Total: Pass" appears for all software.
Server name for the connected
database is correct.
Server name:



Login possible from [View event log].
3-3
Shimadzu User Authentication
Tool connection check
Not implemented because
already implemented in Test 2-3
Lockout by AgentMan2.exe is registered.

Rev. 3.00 Page 30 of 37
Operational Qualification Operational Qualification Record




















Performer (signature): Date: / /
Reviewer (signature): Date: / /

No. Item Criteria Inspection results
Pass Fail
3-4
Security function tests
Not implemented because
already implemented in Test 2-4

3-4-1
Password log management
function check
Duplicated passwords cannot be used.
3-4-2
Number of password characters
check
A password shorter than the minimum length is not accepted while a
password satisfying the minimum length is accepted.

3-4-3 Failed login detection
Login is not possible with an incorrect password but possible with the
correct password.

3-4-4 User lockout function check The user is locked out for the specified lockout time.
3-4-5 Failed login log The login lockout is registered in the log.
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.

3-6
Test of function to prevent
duplicate user registration
Duplicate user cannot be registered and the message Unable to set 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 GCsolution report.
3-8 Data recovery Correct files exist in folder.
Printed report is identical to GCsolution Test 2-10-4.
4
GCsolution automatic
registration function check
(Data integrity check)
Re-registered without overwriting.
Data registered, without overwriting.
5
GCsolution manual registration
function check
Three sets of data are identical.
6 Electronic signature check Electronic signature information is printed correctly.
7 System log recording check Change to configuration settings is registered in the System Log.

Rev. 3.00 Page 31 of 37
Operational Qualification Operational Qualification Record

3-13 Chromatopac C-R7A plus/C-R7Ae Applicable Not Applicable





Performer (signature): Date: / /
Reviewer (signature): Date: / /

Model Name C-R7 plus
Component ID
Serial Number
(S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Inspection results Pass Fail
ROM
VRAM
RAM
Power LED lights
Keyboard LEDs light
BOOT Version
Program Version Ver.
1
Memory
self-diagnost
ic test
Initialization completes without error.
The version number matches
the controlled version number.
Controled
Ver.


Zero point 750 V V
Span 992000 to
1008000V
V
Zeroing 96V V
Linearity 0.1%FS %FS
Slope test 1 to 70V/min V/min
Area 2 % %
Height 1 % % Accuracy
Retention time 1 % %
Area 1 % %
Height 1 % % Range
Retention time 2 % %
Area 0.1 % %
Height 0.5 % %

C
H
1
Repeatability
Retention time 0.8 % %
Zero point 750V V
Span 992000 to
1008000V
V
Zeroing 96V V
Linearity 0.1%FS %FS
Slope test 1 to 70V/min V/min
Area 2 % %
Height 1 % %
Accuracy
Retention time 1 % %
Area 1 % %
Height 1 % %
Range
Retention time 2 % %
Area 0.1 % %
Height 0.5 % %
2
Hardware
validation
"PASS" is
displayed
for all
results
falling
within the
specified
tolerances

C
H
2
Repeatability
Retention time 0.8 % %

Rev. 3.00 Page 32 of 37
Operational Qualification Operational Qualification Record

3-14 Chromatopac C-R8A Applicable Not Applicable








Performer (signature): Date: / /
Reviewer (signature): Date: / /

Model Name C-R8A
Component ID
Serial Number
(S/N)
____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____
No. Item Criteria Inspection results Pass Fail
Program Version Ver.
Memory Check Status Diagnostic Status
1
Memory
self-diagnost
ic test
Initialization
completes
without error.
The version number matches the controlled version
number.
Controled
Ver.


Zero point 750 V V
Span 992000 to
1008000V
V

Zeroing 96V V
Linearity 0.1%FS %FS
Slope test 1 to 70V/min V/min
Area 2 % %
Height 1 % % Accuracy
Retention time 1 % %
Area 1 % %
Height 1 % % Range
Retention time 2 % %
Area 0.1 % %
Height 0.5 % %

C
H
1
Repeatability
Retention time 0.8 % %
Zero point 750V V
Span 992000 to
1008000V
V

Zeroing 96V V
Linearity 0.1%FS %FS
Slope test 1 to 70V/min V/min
Area 2 % %
Height 1 % % Accuracy
Retention time 1 % %
Area 1 % %
Height 1 % % Range
Retention time 2 % %
Area 0.1 % %
Height 0.5 % %
2
Hardware
validation
"PASS" is
displayed
for all
results
falling
within the
specified
tolerances

C
H
2
Repeatability
Retention time 0.8 % %

Rev. 3.00 Page 33 of 37
Operational Qualification Operational Qualification Record

3-15 GC-2010 Gas Chromatograph Analysis System
Applicable Not Applicable

Gas Chromatograph Analysis System
No. Item Criteria Inspection result
Pass Fail
AREA value
__ __.__ __ %
Injection
unit

Detector

N/A
Retention time
__ __.__ __%

AREA value
__ __.__ __ %
Injection
unit

Detector

N/A
Retention time
__ __.__ __%

AREA value
__ __.__ __ %
Injection
unit

Detector

N/A
Retention time
__ __.__ __%

AREA value
__ __.__ __ %
Injection
unit

Detector

N/A
Retention time
__ __.__ __%

AREA value
__ __.__ __ %
Injection
unit

Detector

N/A
Retention time
__ __.__ __%

AREA value
__ __.__ __ %
Injection
unit

Detector

N/A
Retention time
__ __.__ __%

AREA value
__ __.__ __ %
Injection
unit

Detector

N/A
Retention time
__ __.__ __%

AREA value
__ __.__ __ %
1 Repeatability
test
Verify the
repeatability
for the peak,
area and
retention
time.
Auto injector not used
AREA value CV < 10.00%
Retention time CV < 2.00%

Auto injector used
AREA value CV < 1.00% (FID, TCD)
< 8.00%FTD
< 3.00%FPD
< 5.00%ECD
Retention time CV < 0.30%
Injection
unit

Detector

N/A
Retention time
__ __.__ __%



Performer (signature): Date: / /
Reviewer (signature): Date: / /


Rev. 3.00 Page 34 of 37
Operational Qualification Change List

4. Change List
When changing or deleting the contents of this document, or adding new information to this document, record the
revision letter, change list number, page number, reason, date, and name of the Performer in the Change List below,
and obtain the approval of the Reviewer and the Manager.

Revision letter: Assign an alphabetical letter for each revision, starting from A. Give the same revision letter for
changes made at the same time.
Change No: Enter the change number assigned in sequence from 1 onwards in accordance with 1-3 Entries
and Revisions. Increase this number over different revision letters (do not revert the Change No.
to 1 when the revision letter proceeds from A to B, for example).
Page: Enter the page number in which the change, deletion or addition was made.
Reason: Enter the reason for the change, deletion or addition.
Date: Enter the date on which the change, deletion or addition was made.

Revision
letter
Change
No.
Page Reason Date Performer Reviewer Manager









































Rev. 3.00 Page 35 of 37
Operational Qualification Change List

Revision
letter
Change
No.
Page Reason Date Performer Reviewer Manager























































Rev. 3.00 Page 36 of 37
Operational Qualification Change List

Revision
letter
Change
No.
Page Reason Date Performer Reviewer Manager























































Rev. 3.00 Page 37 of 37
Operational Qualification Attached Documents

5. Attached Documents

* Appended data shall be numbered by adding letters in sequence from A to the final page number of this document (e.g.
37-A1/3 - A3/3) and appended to this document after entry in the list above.



Performer (signature): Date: / /
Reviewer (signature): Date: / /


Attached Item Description Page
2-4 Calibration Certificates
Pressure gauge Certificate of traceability
Flow meter Certificate of traceability
Digital temperature indicator Certificate of traceability
Resistance temperature sensor Certificate of traceability
Thermocouple Certificate of traceability
Programmable DC
voltage/current generator

Certificate of traceability
Standard reagents for
performance inspections
Certificate


3-1 GC-2010 Gas Chromatograph
Test 10 FID Sensitivity test Verification Data Appendix 37-
TCD sensitivity test Verification Data Appendix 37-

3-7 FID-2010 Flame Ionization Detector Verification Data Appendix 37-
Test 10 FID Sensitivity test Verification Data Appendix 37-

3-8 FTD-2010 Flame Thermionic Detector Verification Data Appendix 37-
3-9 FPD-2010 Flame Photometric Detector Verification Data Appendix 37-
3-10 ECD-2010 Electron Capture Detector Verification Data Appendix 37-

3-12 GCsolution/Class-Agent Workstation
Test 1-3 Hard disk drive check results Verification data Appendix 37-
Test 1-4 Printer driver test page Verification data Appendix 37-
Test 1-5 Network connection test results Verification data Appendix 37-
Test 2-2 GCsolution program alteration check results Verification data Appendix 37-
Test 2-3 Lockout log Verification data Appendix 37-
Test 2-7 Audit trail Verification data Appendix 37-
Test 2-10 GCsolution function check results Verification data Appendix 37-
Test 3-2 CLASS-Agent program alteration check
results
Verification data Appendix 37-
Test 3-3 Lockout log Verification data Appendix 37-
Test 3-7 Data display, search, and sort Verification data Appendix 37-
Test 4 Automatic database registration function
check results
Verification data Appendix 37-
Test 5 Manual database registration function check
results
Verification data Appendix 37-
Test 6 Electronic signature check Verification data Appendix 37-
Test 7 System log recording check Verification data Appendix 37-
Appendix 37-
3-13 Chromatopac C-R7Aplus/C-R7Aeplus Verification data Appendix 37-
3-14 Chromatopac C-R8A Verification data Appendix 37-


3-4-1 GC-2010 Analysis System
Test 1 Repeatability Test Verification data Appendix 37-