R-019-001 Software validation report_Atlassian_2024

Scope

The aim is to gather additional requirements and configuration specifications not encompassed within the application, together with their respective validations. This ensures adherence to both our internal requirements and those imposed by regulatory bodies. This involves detailing specifications and criteria which are external to the application but fundamental for ensuring our outputs align with all requisite standards and regulations.

This is a revalidation of the software due to changes applied to:

• T-012-001 Requirements
• T-006-001 Non-conformity
• Non-conformity and CAPA workflow

and due to the creation of:

• T-006-003 CAPA
• T-012-013 Design stage review.

The first validation of the software is documented in R-019-001 Software validation report_Atlassian_2023_001.

Software description

Name

Atlassian

Manufacturer

Atlassian corporation (Atlassian Pty Ltd and Atlassian US, Inc.)

Intended use

We selected Atlassian to have a controlled system to be used:

• As Design History File (DHF), to contain all the records required during the manufacturing process
• To register and follow up all the non-conformity and corrective and preventive actions (NC & CAPAs).

Risk-based analysis

Design History File (DHF)

Atlassian is also used as a DHF to register, monitor, review and approve all the software as medical device life cycle information required by the applicable regulations. Failure of the release feature of the application configuration would result in a quality problem that foreseeably compromises safety. As such, we have determined that this function pose a high process risk.

Non-conformities and corrective and preventive actions (NC & CAPAs)

Failure of the NC & CAPAs application to perform as intended may delay the follow up of the NC & CAPAs, but would not result in a quality problem that foreseeably compromises safety, as we have additional processes in place for containment of non-conforming product. As such, we have determined the initiation operations did not pose a high process risk.

Requirements and design specification

Design History File (DHF)

• Requirement 01: Users sign the documentation according to their role and in compliance with the 21 CFR part 11.
• Requirement 02: When the users log in to the DHF they can check the identification of the product and the T-012-005 Design change control record.
• Requirement 03: Users can register the requirements, activities, tests, and version releases on their corresponding section.
• Requirement 04: Users provide the information specified at theGP-012 Design, redesign and development procedure.
• Requirement 05: Users can document design stage review.

Non-conformities and corrective and preventive actions (NC & CAPAs)

• Requirement 01: Users sign the documentation according to their role and in compliance with the 21 CFR part 11.
• Requirement 02: User can identify the status of the non-conformities and CAPA according to GP-006 Non-conformities, Corrective and preventive actions:
  • Non-conformity reception
  • Non-conformity investigation
  • CAPA reception
  • Efficacy verification
  • Impact verification
  • Solved
• Requirement 03: User is able to transfer the NC status as follows:
  • NC reception to NC investigation
  • NC investigation to Solved
• Requirement 04: User is able to transfer the CAPA status as follows:
  • CAPA reception to Efficacy verification
  • Efficacy verification to Impact verification
  • Efficacy verification to CAPA reception
  • Impact verification to Solved
• Requirement 05: User provide the information specified in the GP-006 Non-conformities, Corrective and preventive actions.

Assurance activities and test plan

In addition to the tests and checks designed to ensure the configuration complies with the establised requirements, we have performed an assessment of the system capability (see R-002-007 Process validation card 2023_003) and a supplier evaluation (see R-010-001 Suppliers evaluation), being considered the only tool providing, in the same ecosystem, a task manger, a knowledgebase and a git code repository. This makes it perfect to manage all the process mentioned: QMS, DHF and NC & CAPAs applications.

Design History File (DHF)

ID	Test description	Acceptance criteria	Requirement tested
Test 01	Verification of the electronic signature	Signature comply with the regulatory requirements	Requirement 01
Test 02	Verification that the users can provide all the information required at the GP-012 Design, redesign and development	Templates are correct	Requirement 03, Requirement 04, Requirement 05
Test 03	User validation: to perform a simulation of the performance of the DHF configuration	Satisfactory simulation without errors	Requirement 02, Requirement 03, Requirement 04, Requirement 05

Non-conformities and corrective and preventive actions (NC & CAPAs)

ID	Test description	Acceptance criteria	Requirement tested
Test 01	Verification of the electronic signature	Signature comply with the regulatory requirements	Requirement 01
Test 02	Verification that the users can provide all the information required in the GP-006 Non-conformities, Corrective and preventive actions	NC template and CAPA template contan all the required information	Requirement 05
Test 03	Verification of the different status for the NC and the NC flow is properly established	NC flow properly defined	Requirement 02, Requirement 03
Test 04	Verification of the different status for the CAPA and the CAPA flow is properly established	CAPA flow properly defined	Requirement 02, Requirement 04

Test Results and deviations detected

Design History File (DHF)

Test 01

• Result: Pass
• Deviation: No deviations found

Test 02

• Result: Pass
• Deviation: No deviations found

Test 03

• Result: Pass. The simulation performed worked as expected.
• Deviation: No deviations found

Non-conformities and corrective and preventive actions (NC & CAPAs)

Test 01

• Result: Pass
• Deviation: No deviations found

Test 02

• Result: Pass
• Deviation: No deviations found

NC template

CAPA template

Test 03

• Result: Pass
• Deviation: No deviations found

Non-conformities status

Non-conformities flow

Test 04

• Result: Pass
• Deviation: No deviations found

CAPA status

CAPA flow

Design review

	Result
Have the appropriate tasks and expected results, outputs, or products been established for each software life cycle activity?	TRUE
Do the tasks and expected results, outputs, or products of each software life cycle activity:
Comply with the requirements of other software life cycle activities in terms of correctness, completeness, consistency, and accuracy?	TRUE
Satisfy the standards, practices, and conventions of that activity?	TRUE
Establish a proper basis for initiating tasks for the next software life cycle activity?	TRUE

Conclusion

Design History File (DHF)

Non-conformities and corrective and preventive actions (NC & CAPAs)

No errors were observed in the fields destined for filling the required information. Incorrectly inputting text into the fields is immediately visible and does not impact the risk of the intended use.

In addition, some fields are mandatory for the user to fill in, to avoid loss of required information, and other fields have predefined choices to ensure the proper information is completed.

The tests performed due to new or revised DHF templates and NC & CAPA templates and workflow have been passed with no deviations, so we can consider that the software revalidation has been concluded successfully.

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003, JD-004
• Approver: JD-001