IT & Digital

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eHealth regulatory support

  • Regulatory expertise on connected medical devices and connected health objects
  • Regulatory validation of applications
  • Creation of CE marking technical file

Health Data Expertise

  • Hosting strategy and data protection
  • GDPR

Projects Support

  • e-Health
  • m-Health
  • telemedicine
  • connected medical devices

NORMATIVE ENVIRONMENT

  • GDPR
  • ISO 27001
  • ISO 13485
  • EN 62304

Master data management

  • Data manager
  • Data steward

Data integrity

  • Inventory audit
  • Definition and management of a data integrity action plan

Clinical data management

  • Establishment of clinical database structures
  • Data management, control and validation
  • Design of FIUs and Queries
  • Recording strategy consulting
  • Qualitative evaluation of CDISC (SDTM) and SEND databases for non-clinical
  • Expertise: SAS, ORACLE, CLINTRIAL, INFORM, CLINTRIAL INSIGHT

Normative environment

  • BPF
  • 21 CFR PART 11
  • Gamp5
  • ISO 14155

 

 

 

Information Security Management System

  • ISO 27001 conformity assessment
  • Implementation of an Information Security Management System (ISMS)
  • Back office support and expertise on WSIS and ISS policy (PSSI)
  • Information security awareness and ISO 27001

General Data Protection Regulations (GDR)

  • Conformity Assessment GDR
  • Definition of an GDR compliance action plan
  • Back office support and expertise on GDR
  • GDR Awareness

Normative environment

  • ISO 27001
  • ISO 27005
  • RGPD

IT Quality System

  • Formalization of business processes vs GxP Regulations
  • Validation policy expertise:
  • validation master plan,
  • Standard Operating Procedures (SOPs).

Validation of all types of IS

  • Criticality analysis
  • Consolidation of requirements
  • Validation plan
  • Risk analysis
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (QO)
  • Performance qualification (PQ)
  • Traceability matrix
  • Final validation report
  • Anomaly management
  • Qualification of IT infrastructures

Maintenance in validated condition

  • Audit trail review
  • Change Management
  • Periodical Reviews
  • Training: awareness, initiation and training in CSV

Normative environment

  • GAMP 5
  • 21 CFR Part 11
  • BPF annexes 11 et 15
  • ANVISA Title VII
  • PMDA
  • ISO 13485

Requirements engineering and preliminary design

  • Description of user requirement specification (URS)
  • Drawing up the specifications and the call for tenders
  • Definition of the functional solution (SFG, SFD)
  • Risk assessment and control
  • Selection of editors and solutions
  • Impact analysis on the organization and work processes
  • Project management or AMOA

Project stakeholder management

  • Implementation and monitoring of project indicators (KPI)
  • Change Management
  • IS validation management
  • Integration of all types of IS: ERP, LIMS, MES, CTMS, CMMS, serialization,…

Normative environment

GMP
PMP, IPMA

Urbanization of information systems

  • Inventory and mapping of IS
  • Application Rationalization
  • IT Master Plan

Information systems governance

  • Evaluation / consolidation of the IS management system
  • IT service management: ITIL best practices, IT process definition, IT department service offering definition
  • Third party audit: hosting provider, software publisher.

Normative environment

  • ITL
  • CMMI
  • 21 CFR part 11
  • BPF annexe 11
  • GAMP 5