Experts consultants in regulated sectors · Audits GMP, GCP, GLP, GDP Medical Devices Assistance...
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Experts consultants in regulated sectors Copyright ©CSV Experts 2019
Transcript of Experts consultants in regulated sectors · Audits GMP, GCP, GLP, GDP Medical Devices Assistance...
Experts consultants in
regulated sectors
Copyright ©CSV Experts 2019
AdviceGMP, GLP, GCP, GDP
Validations
Data Integrity
Medical Devices
AuditsGMP, GCP, GLP, GDP
Medical Devices
AssistanceStatus Validation maintenance
Decommissioning
Validation of
computerised
systems
Data IntegrityEvaluations and
implementation of policies
Equipment
qualification
Medical
Devices
Infrastructure
qualification
Training In Company
Training in Barcelona / Madrid
Services
PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
2Copyright ©CSV Experts 2019
We increase the maturity level of organizations
Design of the Quality System
Collaboration in the Compliance of the
Quality System:
Change Control
Incident Management
Configuration Management
System Periodic Review
Internal Audits
VALIDATION
GOVERNANCE
MAINTENANCE OF
VALIDATION
STATUS
Source: ISPE GAMP® Guide: Records and Data Integrity 3Copyright ©CSV Experts 2019
PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
PreClinical Clinical Trials Manufacturing & Distribution
GLP GCP GMP GMP GDP
GxP Consultancy
REVIEWRegulatory compliance status of your
organization
RESOLUTION OF INCIDENTSDetected by audits / inspections
Application
IMPROVEMENT PLANS
Update and application of
NEW REGULATIONS
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PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
Services
QUALIFICATION
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MAINTENANCE AND REMOVAL OF SYSTEMS
ERP(Management of materials and resources)
EDMS(Document management system)
EBR / MES (Electronic Batch Record /
Manufacturing Execution System)
BBDD PHARMACOVIGILANCE
CLINICAL TRIALS(Ecrd, TMF)
Cloud Systems / On Site
SCADA
LIMS(Laboratory Information Management System)
LDAS(Laboratory Instrumentation)
CHANGE CONTROLApplications - Infrastructure
DECOMMISSIONINGControlled removal of servers, PC, equipment
MANTRATraceLink
IT INFRASTRUCTURE, EQUIPMENT AND INSTALLATIONS
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VALIDATION OF COMPUTERIZED SYSTEMS
PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
CSV Experts has developed an agile evaluation and priorization tool in accordance with DIRA (Data
Integrity Risk Assessment).
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Data Integrity Assessment
EVALUATIONData Integrity of systems
PRIORITIZATIONSystems
GAPAssessment
Risk Assessment
Action Plan
Remediation Plan
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PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
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Maintenance of the Validation status of TraceLink ®
ManTra Lite – What we offer?
• TraceLink ® continuous validation and change assessment procedure.
• Tailor-made documentation: only critical aspects are tested.
• Added value: test scripts, execution and evidence detail are handled by the service subscriber.
• Annual subscription: includes every change released by TraceLink ® during subscription period.
• One yearly payment: 2.000 €/year (at the beginning of the subscription).
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PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
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Medical Devices
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REGULATORY ADVICE
• Medical Device classification.
• CE marking.
• Product registration in Europe, USA – 510 (k) and
other countries.
• MDSAP.
• Preliminary licence for the operation of facilities.
ADAPTATION TO THE NEW EUROPEAN
REGULATIONS - MDR AND IVDR
TRAINING “In-Company”
QUALITY SYSTEMS
• Advice and implementation for adherence
to ISO 13485 and 21CFR820.
MANAGEMENT AND RISK ANALYSIS
• In accordance with ISO 14971.
VALIDATIONS
• Mobile Apps
• Software
• Manufacturing processes
PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
A CSV Experts company
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IT Services
PROCEDURES
QUALIFICATION
INSTALLATION
HW & SW
• Services Managed to IT Qualified Infrastructure
• Documentation: Infrastructure Qualification Plans Process / Procedures and training
• IT Infrastructure Qualification
• Hardware and software installation and configuration (time)
• Hardware and software (material)
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QA
PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
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IT Services
• Backup and Restore System Validation
• Disaster Recovery Systems
• Periodic IT Infrastructure Reviews
• IT Pharma Consulting
Copyright ©CSV Experts 2019
• Audit to suppliers
• Audit to pharma IT departments
• Time and material (specialized resources)
• Monitoring
FULL SERVICE TO YOUR IT DEPARTMENT
PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
A CSV Experts company
Some of our customers
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PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
CONSULTANTS
TECHNICIANS
CEO Administration ITQA TranslationQABusiness
Development
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Our team
Copyright ©CSV Experts 2019
Business
Development
PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
ISO 9001:2015
certified
More than 20
employees
In-depth knowledge of regulated environments
Barcelona and Madrid delegations
Join Venture with phIT
(CSV Experts and Ambit BST)
ISPE Spain members
AEFI & Catalonia BIO partners
Among the top 3
consultants of regulated
environments in Spain
More than
150 customers
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More than 500 projects
carried out
Why working with us?PHARMACEUTICAL
MEDICAL DEVICE
COSMETIC
VETERINARY
Barcelona Central Office
Av. Ernest Lluch 32
Tecnocampus Mataró (Torre 3, 2ª planta)
08302 Mataró (Barcelona)
Madrid Delegation
Calle Canarias, 62
28045 Madrid
Contact us
www.csvexperts.com (+34) 93 169 65 [email protected]
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