Firmaprofesional: 2021 Audit Report Finding 2 out of 3

The case addresses an audit finding related to the lack of defined roles and training for Validation Specialists at Firmaprofesional. The audit revealed that the role of Validation Specialist was not explicitly defined, and there was no evidence of periodic training for these individuals. Firmaprofesional responded by implementing an online training course and clarifying the responsibilities of the Validation Specialists. The case was resolved with the implementation of these corrective actions, although concerns were raised about the adequacy of the incident report and the need for systemic controls.

1. 2021-04-08 Non Conformity registered in JIRA and action plan established.
2. 2021-05-28 Role of Validation Specialist validated by HR Director.
3. 2021-10-01 New BRs validity times for domain controls come into effect.
4. 2021-10-13 Upgrade to RA software deployed to ensure yearly review of validation evidence.