Hi,
Can anybody show me an example software test record template?
In GAMP 4, in its appendix, there is a sample template for recording test result.
It has some items that make me confused.
They are:
test ref.
test spec.
So, I need some body show me a GAMP4 compliant test record template.
Many many thanks!
Frank
Have a look at this template its a free download that you may find useful.
http://www.askaboutvalidation.com/featured_articles_expanded.php?uid=24
many thanks! I think the sample test script form you put there is very very helpful for me.
But I still have some confusions on that GAMP test result sheet.(I have some ohter SOPs related to this sheet).
I want to know what should be put into the blank cells.
I put all the titles of the cells here, I hope you can teach me.
Cell title: system
my understanding: the system name
your comments：
cell title : test reference
my understanding: the id of the test item
your comments：
cell title:(controlling test specification ref)
my understanding: referenced item id in FRS
your comments：
cell title: title of test
my understanding: name of this test item
your comments：
cell title: test run number
my understanding: ? ordinal number or test run times?
your comments：
Cell title: test result
My understanding: (input the observed result here, pass or fail? why use so big cell?)
your comments：
Cell title: {Enter detail equipment used(…)}
My understanding: environment or pre-requisites
Cell title: result: pass/fail
My understanding: ?? reduntant to the ‘test result’??
your comments：
Cell title: (incident report reference)
My understanding: (id of the related item in the incident report sheet? why no such cell in that report sheet ?)
your comments：
Cell title: tester sig
My understanding: the tester signe here
your comments：
Cell title: witness sig
My understanding: the user who monitors the tester sig
your comments：
I hope I made the questions clear.
Thanks in advance!
Cell title: system
my understanding: the system name
your comments: Correct - This may refer to the entire cell being tested or an individual piece of equipment
cell title : test reference
my understanding: the id of the test item
your comments: Correct - It may reference section 9.1 for example 9.1 may have 6 diffrerent steps 1-6
cell titlecontrolling test specification ref)
my understanding: referenced item id in FRS
your comments Correct this may reference a Functional Specification Tag (FS) or a Design Specification Tag (DS)
cell title: title of test
my understanding: name of this test item
your comments Correct for example (HMI Alarm Testing)
cell title: test run number
my understanding: ? ordinal number or test run times?
your comments: Correct this may reference a process run or runs
Cell title: test result
My understanding: (input the observed result here, pass or fail? why use so big cell?)
your comments: Correct it depends on what may you are entering your results, you may have alot of text or you may just
input “As Expected” depending on how you decide this in your testing policy
Cell title: {Enter detail equipment used(…)}
My understanding: environment or pre-requisites
Correct, this may be in reference to all the equipment used on the line
Cell title: result: pass/fail
My understanding: ?? reduntant to the ‘test result’??
your comments: The test result will dictate if the result is a Pass or Fail
Cell title: (incident report reference)
My understanding: (id of the related item in the incident report sheet? why no such cell in that report sheet ?)
your comments: This may be in reference if a deviation or discrepancy needs to be raised.
Cell title: tester sig
My understanding: the tester signe here
your comments: Correct usually initial and Date
Cell title: witness sig
My understanding: the user who monitors the tester sig
your comments: This is a review signature from an independent person to ensure everything was done correctly
hope this helps
Hi, GoKeeffe,
I should say many thanks to you! Thank you for your time and thank you for your expertise.