Presentación General CSV Experts - Inglés · Data Integrity Assessment IT Quality Systems...
Transcript of Presentación General CSV Experts - Inglés · Data Integrity Assessment IT Quality Systems...
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Consultancy services
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COMPUTERIZED SYSTEMS VALIDATION
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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
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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
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Computerized Systems ValidationMedical DevicesGMP, GLP, GCP and GDP complianceData Integrity AssessmentIT Quality Systems
PHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
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GMP, GLP, GCP, GDP, ISO 15189COMPLIANCE CONSULTANCY
COMPLIANCE ASSESSMENTCase by case study
ACTION PLANS
COMPLIANCE ASSESSMENT to overcome CAPA
Update to current REQUIREMENTS
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Computerized Systems ValidationMedical DevicesGMP, GLP, GCP and GDP complianceData Integrity AssessmentIT Quality Systems
PHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
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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
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DATA INTEGRITY ASSESSMENT
DATA INTEGRITYPOLICY
PRIORIZATION
GAP Assessment
Risk Assessment
Action Plan
Remediation Plan
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Computerized Systems ValidationMedical DevicesGMP, GLP, GCP and GDP complianceData Integrity AssessmentIT Quality Systems
PHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
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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
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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
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Some customersPHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
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Our teamPHARMACEUTICAL
MEDICAL DEVICES
COSMETHICS
ANIMAL HEALTH AR
EA
S
CONSULTANTS
TECHNICIANS
CEO Administration QAQA InfrastructuresTranslation
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Av. Ernest Lluch 32Tecnocampus MataróTorre 3 –2ª planta08302 Mataró BARCELONA
Tel. (+34) 93 169 65 [email protected]