Validation and Compliance Engineer for Information Systems @ Agidens

Experiences

Mangement of the validation project for a Computerized Maintenance Management System (CMMS)

• Resumption of the User Requirement Specifications (URS)
• Validation strategy definition and data migration in accordance with the regulations, good practices and internal procedures of the company
• Functional risk analysis review and data integrity analysis
• Support of junior staff in the realization of activities and elaboration of deliverables used to build the Coswin system GxP compliance set of documents
• Advice and recommendation related to the software configuration during weekly projects meetings to fluidify and lighten the process of demonstrating conformity
• Creation of a model documentary package (set of template documentation) for system and data migration (Plan, Tests, Reports)

Success: Inter-company cooperation – one of the junior staff was from another company
IT Infrastructures Qualification – Definition & Implementation of a strategy

• Assessment of the maturity level of the key process of the IS department
• Situation Analysis | Advice adapted to the context | Gaps identification related to the management of IT platforms and activities related to their operation
• Audit animation | Opening/closing meeting | Formalization of synthesis and action plan | Audit report
• Construction of a roadmap for the preparation of the compliance project
• Elaboration of the IT infrastructure qualification strategy, including the drafting of a qualification procedure and master plan
• Planification and definition of a prioritization methodology for the qualification of infrastructure components, assistance in carrying out the inventory
• Creation of the documentary package allowing the qualification of the elements identified as “GxP” (Plan, Test Checklist, Report, IT service provider audit)
• Training kit for the operational teams

Success: Creating a link between technical-oriented IT teams and quality-oriented qualification/validation teams.
Management of Computerized Systems Validation projects

• Organization of the biomedical subsidiary local system validation following reorganization
• Monthly presentation of the status of the validation of the IS of the perimeter, maintenance of the schedules
• Launch of compliance projects and validation files for existing systems
• Documentary review of the main deliverables and models
• Resumption of inventories of computerized systems
• Management of a junior whose first experience in IS validation
• Participation in the resolution of deviation/CAPA/changes
• Periodic system review
• Internal training

Success: Evolution and positive communication in the context of a special relationship between IS management and quality assurance
Qualification strategy for excel sheet systems

• Creation of a compliance and validation kit for excel file system (standard URS, protocol, standardized test sheet, report, training material)
• Setting up of the follow-up of the implementation of the compliance

Success: Business operational teams are convinced of securing access and data from Excel-type files used in a regulated context
Validation of computerized systems in the quality control laboratory

• Management of two validation projects for computerized systems used in the quality control laboratory
• Supervision and development of validation skills of a “Junior” consultant (mission carried out in pair)
• Writing of System Validation Plans, Functional Risk Analyses, Qualification Protocols (QI/QO/QP), QI Test Scripts, Qualification Reports, Traceability Matrix, Final Validation Report
• Support on execution of QO/QP tests

Success: Assembly of the two validation files with beginner key user, a junior consultant and a period falling in the month of May in record time and deadlines. The project was more than efficient
IT infrastructure qualification – Definition & Implementation of a Strategy

• Assessment of the maturity level of the key process of the IS department
• Situation analysis | Advice adapted to the context | identification of gaps in the management of the IT platforms and activities related to their operation
• Audit animation | Opening/closing meeting | Formalization of synthesis | Audit report
• Construction of a road map for the preparation of the compliance
• Elaboration of the IT infrastructure qualification strategy, including the drafting of a qualification procedure and master plan
• Planning and definition of a prioritization methodology for the qualification of infrastructure components, assistance in carrying out the inventory
• Creation of the documentary package allowing the qualification of the elements identified as “GxP” (Plan, Test Checklist, Report, IT service provider audit)
• Training kit for the IT operational teams

Success : New recurring missions assigned by the client.
Data Integrity and IS GxP Compliance Audit

Control of IS data integrity
• Assessment of IS life cycle maturity and associated quality processes
• Situation analysis | Advice adapted to the context | Gap identification
• Audit animation | Opening/Closing meeting | Formalization of synthesis | Audit reports
• Provision of recommendation | Elaboration of an action plan
Validation of an ERP

• Realization and review of deliverables related to the validation process (user requirements, validation plan, risk analysis, test plan and script, traceability matrix, report)
• Elaboration of an audit grid for an outsourced IT service provider

Success : Adjusting the system validation effort to the context and scale of a very small company.
Qualification documentation review during the implementation of new infrastructure components

• Review and approval of quality documentation related to IT infrastructure (server, network, storage, virtualization, backup): requirements specification, plans, risk analysis, protocols, test cases, reports
• Contribution to the development of the company’s quality culture
• Provide expertise in terms of methodology to meet the company’s IT quality standards
Review the methodology for the qualification of internalized hosting spaces

• Harmonize the qualification process for IT hosting spaces in collaboration with the US teams

Success: methodology that has become a recognized reference everywhere at a big pharma
Change Advisory Board

• Evaluation of the impact of changes on IT infrastructure
• Support for the change of practices during the modification of the ITSM

Success : Raising awareness of the people involved to reduce the number of refusal of changes
IQTC Training

• Creation of training materials
• Training of newcomers to the principles of validation of computerized systems and of IT teams in the process of installation, qualification and execution of test cases

Success : Work in an international environment – be managed remotely from the US by a non-French speaking person

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Ludivine RICHARD

INFORMATION SYSTEMS | QUALITY | GxP COMPLIANCE & VALIDATION | DATA INTEGRITY | CYBERSECURITY

French

Validation and Compliance Engineer for Information Systems