Hi Rita,
We too use JIRA for p
roject management, change management, validation tracking and reporting in conjunction with confluence system which is used to store documents from our Software development processes.
For the initial verification and validation of JIRA, we performed a functional risk analysis. The risks related to the predetermined individual user and functional requirements of the issue tracking system were assessed for the impact on product safety and performance and data integrity according to the criteria as set in the Software Validation Policy & Master Plan document.
The verification was
executed in three steps:
- The predetermined URS and FRS were verified whether the JIRA can comply with the required features. This verification was based on the features list as specified by the application provider, Attlasian, and was considered part of the IQ and OQ. The verification was reported separately in the URS and FRS verification report.
- The OQ phase involved set-up checks (e.g. availability of User Manuals, finalized training of users, accessibility of the users, authorizations/ roles). This OQ validation test protocol with detailed instructions and pass/fail criteria were made, executed and the results were reported in a separate OQ validation test report.
- The PQ phase is the verification of the requirements of the issue tracking system and was done separately. The functional checks and actual test cases representing common use. PQ validation test protocol with detailed instructions and pass/fail criteria were made, executed and the results were reported in a separate PQ validation test report.
Maintenance:
Depending on the change, the involved risk and the need to re-configure, the application needs to be revalidated. The determination of the need for revalidation and verification of correct functionality and use will be based on the Software upgrade or change notification.
Hope this helps!
Regards,
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Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
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Original Message:
Sent: 04-Apr-2020 11:10
From: Rita Francis
Subject: JIRA validation
Hi everyone,
We are using JIRA by altassian to do our project management, change management, validation tracking and reporting, and risk management and store documents from our processes. We have created specific environments in JIRA to do this.
We were told that because of GAMP-4/5 and 21 CFR part 11 that JIRA needs to be validated.
Does anyone have thoughts on this interpretation of the regs and have they been involved in JIRA validations???
Thanks,
Rita Francis, PhD
Ritapfrancis@icloud.com
Sent from my iPhone, somewhere, someplace, planet earth