Alexandre Duval

I am responsible for ensuring that all computerized systems comply with regulatory requirements and internal procedures.

I support operational teams in maintaining the validated state of systems and actively participate in quality activities related to IT systems, including the update of internal procedures, management of CAPAs and deviations, as well as preparation for and participation in audits and inspections.

Implementation and monitoring of Validation activities in IT Projects.

ERP - SAP: Validation of evolutions on Supply Chain processes (Newdis, ISAP Brasil, Onedis)

Participation in the drafting of URS, Drafting: validation plan, risk analysis, and test protocols and sheets (IQ, OQ, PQ)

LIMS - Labvantage: Validation of installation, data migration, new functionalities, and implemented modules.

Participation in the drafting of URS, Drafting: validation plan, risk analysis, and test protocols and sheets (IQ, OQ, PQ)

EDI iXPath: Validation of the system and its new version

QMS andq: Validation of data migration

Other systems used: ServiceNow, Veeva DMS, Excel

Computerized systems validation (V-Cycle and Agile)

- Development of Validation Plans

- Assistance for drafting and formulation of URS

- Functional risk analysis

- Impact analysis (Release Note/Version Change)

- Development of test protocols and sheets

- Execution of UAT and report writing (Excel, JIRA)

- Performance of and review of operational and performance qualification tests

- Non-conformity management (investigation, ticket tracking, and action plan)

- Periodic system reviews

- Quality reviews of project sprints in Agile mode (JIRA)

- Drafting of traceability matrices, List of project document traceability

Systems: FEDERATES, LSRIMS - ArisGlobal, MESO QuickPlex, MSD, PowerBI