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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
Control # 214-YYZZ.##
208-9813.732 /001, System Access ID/Password, Internal Use Test
Protocol, 01/27/10 Page 1 of 15
Document Tracking
Dept. Responsibility: Respon. Function Last DCO #: xxxxxxx
Release Date: xx/xx/xx Unless stamped Distribution Copy and dated,
this document is for reference only. User is responsible for
obtaining current revision. For a controlled copy, please contact
by email DL- Doc Control.
1. Purpose
1.1. The purpose of this operational qualification test script
is to test URS SECTION NAME functionality related to the SCRIPT
NAME as per section 6.2.X in Customer User Requirements
Specification (URS) document number
#200-9813.01-00.
2. Scope
2.1. The scope of this test protocol includes the following user
requirement (s):
REQ-000 - The system shall require users to enter both a User ID
and password before granting access
REQ-000 - The system shall require the account/password
combination to be unique for each user account.
3. Reference Documents
Number Description 200-9813.01-001 User Requirements
Specification (URS)
102-0600.05-001 Software Assessment, Microsoft Dynamics AX 2009
ERP System
216-9813.02-001 Validation Plan, Microsoft Dynamics AX 2009 ERP
System
202-9813.10-001 Hardware Specification, Microsoft Dynamics AX
2009 ERP System
202-9813.11-001 Specification Trace Document, Microsoft Dynamics
AX 2009 ERP System
800286-001 WI, Quality Data Recording
4. Definitions
Acronym, Abbreviation
Definition
ABA American Bankers Association
ACH Automated Clearing House
AMT Alternative Minimum Tax
AP Accounts Payable
AQL Acceptable Quality Level
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
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Protocol, 01/27/10 Page 2 of 15
Acronym, Abbreviation
Definition
AR Accounts Receivable
BFS Back from Sterilization
BOL Bill of Lading
BOM Bill of Materials
CA-AMT California Alternative Minimum Tax
CAPA Corrective and Preventive Actions
CAPARB CAPA Review Board
COC Certificate of Compliance
COS Cost of Sales
CRM Customer Relationship Management
DAX Microsoft Dynamics AX
DOM Date of Manufacture
ECO Engineering Change Order
ECR Engineering Change Request
eDHR Electronic Device History Record
EDI Electronic Data Interchange
ERP Enterprise Resource Planning
ESD Electrostatic Discharge
FCA Field Corrective Action
FCA Field Corrective Action
FGI Finished Goods Inventory
FIFO First-in, first-out
FMEA Failure Mode and Effects Analysis
FRU Field Replaceable Unit
FSA Field Service Activity
FSE Field Service Engineer
FSR Field Service Report
GAAP Generally Accepted Accounting Principles
GL General Ledger
ICC International Chamber of Commerce
INFS In for Sterilization
KPI Key Performance Indicator
LDPM Limited Distribution Product Matrix
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
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208-9813.732 /001, System Access ID/Password, Internal Use Test
Protocol, 01/27/10 Page 3 of 15
Acronym, Abbreviation
Definition
LHR Lot History Record
MDR Medical Device Reporting
MDV Medical Device Vigilance
MES Manufacturing Execution System
MRB Materials Review Board
N/A Not Applicable
NCR Non-Conformance Report
OFS Out for Sterilization
OOSR Out-of-specification Report
Part 11 The chapter of the Code of Federal Regulations that
applies to the use of electronic records and electronic signatures
that are used in the fulfillment of record requirements set forth
in FDA regulations.
PMDA Pharmaceuticals and Medical Devices Agency
PO Purchase Order
PSR Product-Specific Rules
QA Quality Assurance
QAD QAD MFG/PRO Enterprise Resource Planning System
QE Quality Engineer
QFI Quality Final Inspection
QRI Quality Receiving Inspection
QUAR Quarantine
RA Regulatory Affairs
RBFS Refurbished, Back from Sterilization
RFGI Refurbished Finished Goods Inventory
RFID Radio Frequency Identification
RFS Ready for Sterilization
RMA Return Merchandise Authorization
ROFS Refurbished out for sterilization
RTest Refurbished
RTS Return to Stock
RTV Return to Vendor
RWIP Reconditioned Work In Progress (or Process)
Sensitive Account A customer who has submitted three or more
complaints within the previous 90 days.
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
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Protocol, 01/27/10 Page 4 of 15
Acronym, Abbreviation
Definition
SO Service Order
SOP Standard Operating Procedure
SOX Sarbanes-Oxley
UOM Unit of Measure
USD U.S. Dollars
VA Customer Atlanta
VB Customer Billerica
VCR Customer, Costa Rica
VE Customer Europe
Ver. Version
VJ Customer Japan
VoE Verification of Effectiveness
VRC Customer, Rancho Cordova
WI Work Instruction
WIP Work In Process (or Progress)
XBRL eXtensible Business Reporting Language
5. Responsibilities
5.1. Owner Responsible for organizing the validation and/or
implementation effort. Approves test script changes once the test
protocols are approved
5.2. Tester Executes the test protocol, marks the realized test
results, documents the actual result when it differs and seeks
approval when deviations to the protocol are necessary
5.3. Reviewer Reviews the executed test protocol, review proof
of execution data, assures compliance to good documentation
practices, and marks the overall test case result.
5.4. Quality Assurance Responsible for approving protocol
deviations
6. Materials/Equipment Used
6.1. Raltus Procedure Capture software was used to capture and
run all OQ test protocols.
7. Procedure
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
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208-9813.732 /001, System Access ID/Password, Internal Use Test
Protocol, 01/27/10 Page 5 of 15
The execution methodology used to run the test protocols is
defined below. The Test Corrections, Tester and Reviewer sections
are included in all test protocols.
7.1. Protocol
7.1.1. Test Corrections Minor test inconsistencies such as
typos, spelling errors, obvious omissions shall be corrected and
initialled and dated before completing the test. A comment as to
why the correction was made can be added to the Comments sections
at the end of the test case.
7.1.2. Tester - For each test case below, the tester shall
execute the test steps using Raltus Procedure Capture as written.
When the Expected Results are realized for the test step, the
tester will circle the P in the Result column and go on to the next
step. When the Expected Results are not realized for a test step,
the tester shall circle the F in the result column, note the actual
result in the Result if Failed column, and then consult with the
Project Lead to determine whether execution of this procedure (and
others) will be suspended, and if so when it may be resumed or
restarted.
7.1.3. Reviewer The reviewer will review the executed test cases
once protocol execution is complete. The test case results at each
test step and all test documentation shall be reviewed. The
reviewer is to confirm that all results are properly marked and
that all documentation complies with Good Documentation Practices.
After reviewing all test steps for the test case, the Reviewer
shall mark Pass in the Test Status box if all test steps passed, or
mark Fail if any test step did not pass, sign in the Review Section
and enter the date the review occurred.
7.2. Test Case Standards
The following paragraphs below define the set of standards
developed to assist in ensuring complete test coverage and
consistency in test case creation. The test case standards are
documented here.
7.2.1. All requirements will map to tests
7.2.2. N/A maybe used in the Req ID column if the test step is
not verifying the actual requirement, but is necessary to create a
state the requirement under test can be examined
7.2.3. Each requirement will have positive and negative tests
when applicable
7.2.4. Field limits will be tested when noted in the
requirements
7.2.5. Test data will be prepared and entered into the database
before testing begins
7.2.6. Test data will be documented and provided to the test
case originator for use in the creation of test scripts
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
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Protocol, 01/27/10 Page 6 of 15
7.2.7. Terminology will be used as defined by the module owner.
Each test protocol will document standard definitions in the
definitions section of the protocol
7.2.8. Test Cases are to be stand alone when ever possible. If a
prior test is required to be executed before the next test case can
begin the test case must state that in the first step of the test
case.
7.2.9. All tests will contain an expected result.
7.2.10. All test cases will be executed on the test system
before they are finalized and check into Agile. (This is part of
the beta testing activity)The System shall have an IQ/OQ.
7.2.11. All test protocols have been reviewed and are approved
in Agile
7.2.12. All requirements are frozen and approved in Agile
7.2.13. SOP's and WI's being used during validation and/or
implementation are approved in Agile.
7.2.14. Records are retained in accordance with 800176-001
Control of Quality Records.
7.3. Test Case Corrections, Deviations, and Documentation
The purpose of this section is to describe the general
requirements that must be adhered to during the test case
execution.
7.3.1. Test Corrections Minor test inconsistencies such as
typos, spelling errors, and obvious omissions shall be corrected
and initialed and dated before completing the test. A comment as to
why the correction was made is added to the Comments section at the
end of the test case.
7.3.2. Test Deviations Non trivial errors in test steps require
a Deviation. When a test deviation is necessary, the tester will
work with the product owner and management to document the
deviation in the Deviation Section at the end of the test case. The
product owner and management will then review the deviation section
before the test is resumed and sign and date the Deviation.
Deviations can include, but are not limited to test failures that
have an acceptable work around, test that do not follow the
required sequence, and incorrect expected results.
7.3.3. Test Documentation All test execution activities shall be
documented by the tester and signed and dated. Hardcopy documents
(such as screen prints or reports) that are attached as evidence of
execution shall comply with WI, Data Recording Requirements
(800286001). For comments, observations, statements, that are
written anywhere on any part of a protocol, for any reason, the
tester's initials and date shall be included immediately following
the written text or notes.
7.4. Test Cross Reference
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
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208-9813.732 /001, System Access ID/Password, Internal Use Test
Protocol, 01/27/10 Page 7 of 15
Each test case in the test protocol demonstrates compliance to
defined behavior as identified within the User Requirements
Specification # 200-9813.01/002.
8. Test Cases
8.1. Participants All testers and reviewers will print and sign
their name with their title on the executed protocol.
Print name Sign name Title
8.1.1. _________ ________ ___________
8.1.2. _________ ________ ___________
8.1.3. _________ ________ ___________
8.2. Configuration The test configuration will be documented on
the executed protocol. Software shall include version
information.
8.2.1.
______________________________________________________
8.2.2.
______________________________________________________
8.2.3.
______________________________________________________
8.2.4.
______________________________________________________
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
Control # 214-YYZZ.##
208-9813.732 /001, System Access ID/Password, Internal Use Test
Protocol, 01/27/10 Page 8 of 15
8.3 Operational Qualification Test
Test Case Description The purpose of this test is to....
STEPS
No. Procedure Step Expected Result Actual Result P/F Initial
1.
Left Click
Click on Siebel at bottom
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
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Protocol, 01/27/10 Page 9 of 15
2.
Left Click
Go to the Accounts screen at top
3.
Left Click
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
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208-9813.732 /001, System Access ID/Password, Internal Use Test
Protocol, 01/27/10 Page 10 of 15
4.
Left Click
5.
Left Click
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
Control # 214-YYZZ.##
208-9813.732 /001, System Access ID/Password, Internal Use Test
Protocol, 01/27/10 Page 11 of 15
6.
Type
Marriott
7.
Left Click
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
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208-9813.732 /001, System Access ID/Password, Internal Use Test
Protocol, 01/27/10 Page 12 of 15
8.
Left Click
9.
Left Click
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
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208-9813.732 /001, System Access ID/Password, Internal Use Test
Protocol, 01/27/10 Page 13 of 15
10.
Left Click
11.
Screen Check
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
Control # 214-YYZZ.##
208-9813.732 /001, System Access ID/Password, Internal Use Test
Protocol, 01/27/10 Page 14 of 15
12.
Screen Check
13.
Left Click
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Microsoft Dynamics AX 2009 ERP System Operational Qualification
(OQ)
Control # 214-YYZZ.##
208-9813.732 /001, System Access ID/Password, Internal Use Test
Protocol, 01/27/10 Page 15 of 15
Comments (Required if test fails) Additional comments or special
results are recorded here. Test Deviations: Management Approval:
Date: Attestation I, the undersigned, performed the above Test Case
and certify that all information provided by me on this Test Case
is complete and accurate. Performed by:
Test Date:
Test Status: PASS FAIL Reviewed by:
Review Date:
1. Purpose2. Scope3. Reference Documents4. Definitions5.
Responsibilities5.1. Owner Responsible for organizing the
validation and/or implementation effort. Approves test script
changes once the test protocols are approved5.2. Tester Executes
the test protocol, marks the realized test results, documents the
actual result when it differs and seeks approval when deviations to
the protocol are necessary5.3. Reviewer Reviews the executed test
protocol, review proof of execution data, assures compliance to
good documentation practices, and marks the overall test case
result.5.4. Quality Assurance Responsible for approving protocol
deviations6. Materials/Equipment Used6.1. Raltus Procedure Capture
software was used to capture and run all OQ test protocols.7.
Procedure7.1. Protocol7.1.1. Test Corrections Minor test
inconsistencies such as typos, spelling errors, obvious omissions
shall be corrected and initialled and dated before completing the
test. A comment as to why the correction was made can be added to
the Comments...7.1.2. Tester - For each test case below, the tester
shall execute the test steps using Raltus Procedure Capture as
written. When the Expected Results are realized for the test step,
the tester will circle the P in the Result column and go on
t...7.1.3. Reviewer The reviewer will review the executed test
cases once protocol execution is complete. The test case results at
each test step and all test documentation shall be reviewed. The
reviewer is to confirm that all results are properly ma...7.2. Test
Case Standards7.2.1. All requirements will map to tests7.2.2. N/A
maybe used in the Req ID column if the test step is not verifying
the actual requirement, but is necessary to create a state the
requirement under test can be examined7.2.3. Each requirement will
have positive and negative tests when applicable7.2.4. Field limits
will be tested when noted in the requirements7.2.5. Test data will
be prepared and entered into the database before testing
begins7.2.6. Test data will be documented and provided to the test
case originator for use in the creation of test scripts7.2.7.
Terminology will be used as defined by the module owner. Each test
protocol will document standard definitions in the definitions
section of the protocol7.2.8. Test Cases are to be stand alone when
ever possible. If a prior test is required to be executed before
the next test case can begin the test case must state that in the
first step of the test case.7.2.9. All tests will contain an
expected result.7.2.10. All test cases will be executed on the test
system before they are finalized and check into Agile. (This is
part of the beta testing activity)The System shall have an
IQ/OQ.7.2.11. All test protocols have been reviewed and are
approved in Agile7.2.12. All requirements are frozen and approved
in Agile7.2.13. SOP's and WI's being used during validation and/or
implementation are approved in Agile.7.2.14. Records are retained
in accordance with 800176-001 Control of Quality Records.7.3. Test
Case Corrections, Deviations, and Documentation7.3.1. Test
Corrections Minor test inconsistencies such as typos, spelling
errors, and obvious omissions shall be corrected and initialed and
dated before completing the test. A comment as to why the
correction was made is added to the Comments s...7.3.2. Test
Deviations Non trivial errors in test steps require a Deviation.
When a test deviation is necessary, the tester will work with the
product owner and management to document the deviation in the
Deviation Section at the end of the test ...7.3.3. Test
Documentation All test execution activities shall be documented by
the tester and signed and dated. Hardcopy documents (such as screen
prints or reports) that are attached as evidence of execution shall
comply with WI, Data Recording Re...7.4. Test Cross Reference8.
Test Cases8.1. Participants All testers and reviewers will print
and sign their name with their title on the executed protocol.Print
name Sign name Title8.1.1. _________ ________ ___________8.1.2.
_________ ________ ___________8.1.3. _________ ________
___________8.2. Configuration The test configuration will be
documented on the executed protocol. Software shall include version
information.8.2.1.
______________________________________________________8.2.2.
______________________________________________________8.2.3.
______________________________________________________8.2.4.
______________________________________________________