Embed Size (px)
Citation preview
Consultancy services
COMPUTERIZED SYSTEMS VALIDATION
•
Computerized Systems ValidationMedical DevicesGMP, GLP, GCP and GDP complianceData Integrity AssessmentIT Quality Systems
ERPMaterials and
resources management
EDMS
EBR / MESElectronic Batch Record
Manufacturing Execution System
SCADA
PHARMACOVIGILANCE
CLINICAL TRIALS
INFRASTRUCTURE QUALIFICATION
LDASLaboratory Data
Acquisition Systems
PHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
LIMSLaboratory Information
Management System
MEDICAL DEVICES
REGULATORY ASSESSMENT
• EU Medical Device classification• 510 (k)• Manufacturing licenses
VALIDATION
• Mobile Apps • Software• Manufacturing process
RISK MANAGEMENT
ISO 14971
QUALITY SYSTEMS
ISO 13485
21CFR820
EQUIPMENTS QUALIFICATION
TRAINING
•
Computerized Systems ValidationMedical DevicesGMP, GLP, GCP and GDP complianceData Integrity AssessmentIT Quality Systems
PHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
GMP, GLP, GCP, GDP, ISO 15189COMPLIANCE CONSULTANCY
COMPLIANCE ASSESSMENTCase by case study
ACTION PLANS
COMPLIANCE ASSESSMENT to overcome CAPA
Update to current REQUIREMENTS
•
Computerized Systems ValidationMedical DevicesGMP, GLP, GCP and GDP complianceData Integrity AssessmentIT Quality Systems
PHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
•
Computerized Systems ValidationMedical DevicesGMP, GLP, GCP and GDP complianceData Integrity AssessmentIT Quality Systems
PHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
CLINICAL RESEARCH
AUDITS R&D
GCP AUDITS (CT, CRO, site)
Technical AUDITS (eCRF, eTMF, DM, Stats)
Specialized AUDITS (GCDMP)
SUPPORT STANDARDS
IMPLEMENTATION
CDISC
CDASH
SDTM
QUALITY SYSTEM
SOPs
Risk Management
Metrics
DATA INTEGRITY ASSESSMENT
DATA INTEGRITYPOLICY
PRIORIZATION
GAP Assessment
Risk Assessment
Action Plan
Remediation Plan
•
Computerized Systems ValidationMedical DevicesGMP, GLP, GCP and GDP complianceData Integrity AssessmentIT Quality Systems
PHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
IT QUALITY MANAGEMENT SYSTEM
QMS
SDLC
Security
Backup & Recovery
Monitor
Changes
Incidents
Delivery
Risks
CAPA
Periodic Review
CONSULTANCY SERVICE FOR IT QMS
BUSINESS NEEDS
IDENTIFICATION
SYSTEMATIC APPLICATION
REGULATORY ASSESSMENT
•
Computerized Systems ValidationMedical DevicesGMP, GLP, GCP and GDP complianceData Integrity AssessmentIT Quality Systems
PHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
QUALITY ASSURANCE
INTERNAL AUDITS
3RD PARTY AUDITS
Some customersPHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
Our teamPHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
CONSULTANTS
TECHNICIANS
CEO Administration QAQA InfrastructuresTranslation
Av. Ernest Lluch 32Tecnocampus MataróTorre 3 –2ª planta08302 Mataró BARCELONA
Tel. (+34) 93 169 65 [email protected]
