ACCESS 2

AUTOMATED
IMMUNOASSAY
ANALYSER

OPERATIONAL QUALIFICATION

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Operational Qualification –ACCESS 2 page 1
OPERATIONAL QUALIFICATION
SYSTEM CERTIFICATION

Study date has determined that the system described in this document either meets all
criteria outlined in this Operational Qualification protocol. All exceptional conditions if
any have been addressed. The system is ready for specified usage.

Protocol performed by: Beckman Coulter Representative

Name: ………………..…………………………….

Title: ………………………………………………..

Company: …………………………………………..

Customer Authorization:

Name: ………………..…………………………….

Title: ………………………………………………..

ENGINEER SIGNATURE CUSTOMER SIGNATURE

DATE DATE

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OPERATIONAL QUALIFICATION – SYSTEM VERIFICATION REPORT

This is to certify that the following checks mentioned in the operational verification
protocol have been performed and found to be satisfactory.

1] CHECKING THE CHEMISTRY ANALYTICAL UNIT

A] SOFTWARE BOOTING & INITIALIZATION

B] SYSTEM CHECKS

2] CALIBRATING THE CHEMISTRIES

3] RUNNING CONTROLS

4] TRAINING THE OPERATORS

ENGINEER NAME AND SIGNATURE CUSTOMER NAME AND SIGNATURE

Appendix
SYSTEM CHECK REPORT
CAL& QC REPORTS
OPERATORS TRAINING CERTIFICATE

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 ACCESS 2– AUTOMATED IMMUNOASSAY
ANALYSER
OPERATIONAL QUALIFICATION

The operational qualification procedure specifies the methodology for the installation of the
specified system after successful Installation qualification. Successful completion of the
specified protocols and is ready for operation and subsequent performance analysis.

REFRENCE OQ Protocol

1. System software loading

2. System Booting and Initialization
3. System Checks

Reference

Operation manual ACCESS 2

Service manual ACCESS 2

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 OPERATIONAL QUALIFICATION

Run the System Check

Configure the System
Calibrate Assays and Run Controls
Clean Up and Complete Documentation

Run the System Check

To complete the System Check procedure, perform the following steps:

Step Action
1. Run the System Check and ensure that ALL system check specifications are met.
• Refer to “Routine Maintenance” in the online Help System or Operator’s Guide for instructions. If
specifications are not met, then refer to “Diagnostics” in the online Help System or Reference
Manual.
2. Verify that the drift correction factor (listed as “Drift Corr” on the report) is 0.9–1.1.
3. Verify that the dark count reading listed on the system check report is <150 RLUs.
4. Print the System Check report and the Alignment report and place them in the customer’s
Maintenance and Service Log.

Configure the System

Perform these steps to configure the system, with customer input where applicable.
In Software Function… Configure the Following…
System Setup

• Change the System ID to the Oracle Instance Number.

• Set the Date and Time Formats.
• Enter the Report Header information (with customer input).
• Configure Report to Printing (if desired).
• Select the Language (for screens, reports, and online Help). Bar Code Reader Setup
• Set Bar Code Symbology Parameters.
• Enable/Disable Bar Code Read of Sample IDs. LIS Setup
• Configure the LIS and verify communication, if applicable. PC Administration Setup
• Configure the system backup time.
• Configure the auto delete feature.
 Tests Setup - Enable all tests that the customer will be using.
• Set the default units and sample type.
 QC Setup - Set up all controls the customer will be using.
 Test Panels Setup: Configure any test panels the customer will be using.
 Derived Results Setup Configure any derived results the customer will be using.
 Reflex Tests Setup Configure any reflex tests the customer will be using.
 System Configuration
 Worksheets

Print configuration setups from their respective menus or fill out the system configuration
worksheets, located in the Help System or Reference Manual.

• System Setup Configurations.

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Operational Qualification –ACCESS 2 page 5
 • Tests Configurations.
• Test Panel Configurations.
• Derived Result Configurations.
• Reflex Test Configurations.

Other Place bar code labels on the sample racks. Choose labels corresponding the customers
sample tube requirements.

• Refer to “Racks and Sample Containers” in the Help System or Operator’s Guide for assistance.
Confirm that the Utility assay is enabled. Refer to “Routine Maintenance” in the Help System or
Operator’s Guide for assistance.

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Calibrate Assays and Run Controls
Perform these steps to evaluate system performance

NOTE: If the customer has requested assay verification studies, then skip this section and refer to “Installation
Assay Verification Protocol” in Chapter 7: “Installation” in the Access Systems Applications database for
instructions.

Step Action
1. Configure the appropriate calibrators and controls. (Use the customer’s controls, or the
Lyphochek controls that were shipped with the system, if customer controls are unavailable.)
• Refer to “System Configuration” in the Reference Manual for instructions.
2. Program the system to calibrate the appropriate assays.
• Refer to “Sample Management: Calibration Test Requests” in Operator’s Guide for instructions.
3. Program 10 replicates of each control.
• Refer to “Sample Management: Quality Control Test Requests” in the Operator’s Guide for
instructions.
4. Pipette appropriate amounts of each calibrator and control into 2 mLsample cups, and place
them in the appropriate sample rack positions.
• Refer to “Sample Processing” in the Operator’s Guide for instructions.
5. Load the sample racks onto the sample carousel, and select Run to start sample processing.
6. Observe instrument operation during the run, and verify that the run completes normally and no
abnormal event log messages are generated.
7. Calculate the mean and %CV for each of the controls. Then confirm that the means fall within the
acceptable ranges, and that the %CVs are consistent with those provided in the “Assay
Information” section of the Instructions for Use.
• Refer to “Peer Group Comparisons” in the Access Systems Applications database.
8. Place a copy of each assay calibration report in the Installation Documentation section of the
customer’s Installation Implementation Guide, or in the “Assays” section of the customer’s
Maintenance and Service Log.
9. Print a copy of each QC Data Report for the customer to review and approve.

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Clean Up and Complete Documentation
Perform these steps to clean up the system and complete the documentation.

Step Action

1. Unload all sample racks and any empty reagent packs from the AU.
2. Wipe the exterior of the AU with a moistened cloth and wipe up any precipitate from previous
leaks or spills. (Use whatever cleaner the lab routinely uses.)

NOTE: In the absence of a preferred laboratory disinfectant, use a bleach solution containing approximately
500 ppm available chlorine. (If using standard household bleach, this is a 1/100 dilution in diH 20.) Bleach
solutions stronger than this are corrosive and will damage the exterior of the Access 2 instrument.

3. Ensure that all covers fit snugly, and that all hardware is in place.
4. Record the system ID number in the appropriate field on the system identification card and apply
the card holder to the front of the AU.

Note: If multiple systems are networked, place client or server ID cards in the holders as appropriate.

5. Complete the Access System Installation Record (PN 110645). Include the appropriate Service
Order number(s).
6. Assemble all system manuals and then review the completed Access System Installation Record
with the customer. Have the customer sign the installation record in the space provided. Place a
copy in the “Installation Documentation” tabbed section of the Installation Implementation Guide.
7. Complete the Service Order or document the service activity in the appropriate system. Place a
hard copy of the report or service record in the “Service” tabbed section of the Maintenance and
Service Log.

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