This
is the story of one of fortune 100 HealthCare company. Since they are into HealthCare
business, any application which is either directly or indirectly dealing with
the patient related information it should be a validated system, meaning should comply with CFR part 12 FDA
guidelines. For these applications Quality
Center/ ALM tool is being used for the test management hence as per the
requirements QC/ALM should be validated.
Robust
workflows are created using QC/ALM customization to comply with FDA guidelines
and satisfy the compliance requirement. These workflows are working fine if the end
users are trying to perform any action (correctly restricting the update/delete
of approved entity) using front end UI. And
the problem comes in when all the rules are bypassed if the users are trying to
update an approved entity using excel plug-In. We got into a situation
where we need to disable the excel upload feature to the end users and allow it
only to specific users(ALM administrators).
Below
is the trigger which is being deployed to accomplish.
BEFORE
INSERT ON PROJECT_SESSIONS
FOR
EACH ROW
DECLARE
CType varchar(255);
uname
varchar(255);
BEGIN
select
LS_Client_Type,LS_USER_NAME into CType,uname from Login_Sessions where
ls_id=:New.ps_ls_id;
IF
CType= 'OTAClient' and uname not in(‘<User Name>’) and
((instr(:New.PS_PROJECT_NAME,'_GxP')
>1))) then
RAISE_APPLICATION_ERROR(-20000, 'Y');
End
if;
END;
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