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CODEX Validation Group is a consulting company with broad experience in the cGMP, compliance, automation, and validation for the Pharmaceutical, Biotechnology and Medical Device industries committed to follow the highest ethical standards as we work with our customers.
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VALIDATION ENGINEERING STAFFING
www.codexvalidationgroup.com
Company Foundations
Codex Validation Group, Inc. was founded by two (2) professionals with over 12 years of experience (over 25 years combine) in the Professional Service field serving multiple satisfied clients.
International experience in the cGMP Compliance, Automation and Validation for Pharmaceutical, Biotechnology, and Medical device industries.(Puerto Rico, USA “East and West Coast”, Europe, and Latin America. )
Company Root
Our professionals are mind oriented to the service support with a high degree of understanding of the fast and critical phases that the majority of companies are confronting today.
Professionals with experience working in high regulated environments such as consent decrees, inspections, remediation actions, and Audits as internal resource and/or third party auditors.
Mission
Our Mission is to become the leader in the Regulatory Compliance, Engineering and Technical Support Services, for the manufacturing challenges.
We hold out our mission by creating a hands-on partnership with our customers and provide reliable and cost effective solutions.
Vision
Our vision is to become a leaders as engineering and validation solution provider that optimize asset reliability, performance and regulatory compliance. To be recognized by our customers as the best engineering and validation support partner that helps them achieve their business goals consequently.
Codex Validation Group Organizational CHART
Company Officers
AccountingHuman Resource
Engineering IT Compliance
Validation
Company Highlights• Provides Engineering, and Regulatory
Services • Employees with over 15 years in the
industry with local offices at Puerto Rico.• Our Core Team have provide services in
over 15 Pharmaceuticals Costumers (P.R., U.S.A. and Europe)
• Process Engineering with Extensive Project Implementation and Integrated Automation Experience.
• Knowledge in Pharmaceutical, Medical Device, Diagnostic and Biotechnology industries.
Services Experience, competence and dedication – our
employees embody these. We offer a staff of talented individuals to fill your validation, compliance, and technical services needs. We will provide you with talent that fits your specific requirements. Our flexible team will work under your supervision assuring that your goals are successfully achieved.
Validation Services
Regulatory
Resourcing
Engineering
Technical Expertise Regulatory Compliance/Validation
Regulatory Compliance Assessment Validation Master Plans Computer System Validation (SDLC) System Criticality Assessment Manufacturing and Packaging Equipment's
Qualification Software Quality Assurance Program Laboratory Equipment Qualification Cleaning Validation Manufacturing Process Validation Packaging Process Validation Process Validation
Technical Expertise Regulatory Compliance/Validation (Continued)
Standard Operation Policies Process Improvement and Operating
Procedures Development Virtual Process/Network Qualification
Automation QualificationExpertise in System Development Life Cycle (SDLC) Documents Preparation
Validation Master Plans User Requirements System Design Documents Traceability Matrix Functional Requirements Vendor Qualification Design Requirements Specifications IQ/OQ/PQ Documents Validation Reports
Automation QualificationExpertise in System Development Life Cycle (SDLC) Documents Preparation (Continued)
System Level Impact Assessment Part 11 Assessments Criticality Assessment Validation Reports
Qualification ExpertiseComputer Qualification
SCADA PLCS Virtual Network Remote Access Servers
Qualification Network
Qualification
LIMS Maximo Batch EBI SAP MES
Qualification Expertise Utilities Qualification
Water Systems Steam Systems Clean Steam Systems HVAC Systems Compress Air Systems Boilers Vacuum Systems Chilled Water System Air Handing Units (AHUs)
Qualification Expertise Purified Water system(Commissioning & Qualification)
RO Vapor Compression CDI USP Loop System WFI Loop System Water Distillation System
Qualification ExpertiseCompressed Air System(Commissioning, & Qualification)
Dryers (Refrigerant & Desiccant) Air Compressor Distribution System Clean Steam Process Air
Equipment Qualification Expertise (Solid Dosage Form & Parenteral)
Lyophilized Filler Stopper Autoclaves Fluid Bed
Granulators and Dryers
Tablet Inspection Vision System
Dryers Blenders
Compressing Machines
Coating Machines Encapsulation
Machines Cream Tanks & Lines CIP/SIP Skids Dust Collectors Ovens
Packaging Qualification Experience(Solid Dosage Form & Parenteral)
Bottle Oriented Machine Filler Machine Capper Machine Labeler Machine Induction Cap sealer Machine Cartoner Machine Bundler Machine Outsert Placer Machine Retorquer Machine Pallitizer Machine Blister Machine Cavity Sealer Machines Shrink Wrap Machines
Packaging Equipment Experience (Cont.) Auto bagger Machines Label Printers Vision Inspection System Hand Held Bar Code Inspection Systems Foil Printers Industrial type PLC for packaging machines Vials Inspection Machine
Cleaning in Place Systems Experience
Intermediate Bulk Containers Solution Tanks Fluid Bed Granulators and Dryer Compression Machines Encapsulation Machines Solutions Delivery Pumps Product Transfer Lines CIP
Project Management (Cont.)We Just Deliver! Our dynamic approach, with a clear idea of the manufacturing requirements, and results-oriented attitude serve to prove the we are leaders in manufacturing/packaging project management. We can do:
Contract administration Document control Project controls delivery Project execution planning Scheduling
Project Management (Cont.) (Engineering Documentation) We Just Deliver! Our dynamic approach, with a clear idea of the manufacturing requirements, and results-oriented attitude serve to prove the we are leaders in manufacturing/packaging project management. We can do:
Master PlansFATSATJob PlansProject execution planning Scheduling
Start-up / Commissioning/Factory Acceptance Test, /Training
We can assess the facility to determine the appropriate Computerized Maintenance Management Solution.
Paperless Solutions Part 11 Assessment Backlog Management Data Clean-up Help Desk Evaluation
Computerized Maintenance Management Solution
Regulatory Expertise
FDA ISO OSHA ISPE KFDA European Medicine Agency (EMA)
What Strategy we use?
Simple, we deliver! It’s about our people and their commitment to go beyond expectations. First at all, ensure that we add value to our client day to day operation by an effective and fast solution. Provide cost effective strategies for a day to day situation. Afford professionals with vast experience in the required consulting area.
What is the Difference
At Codex Validation Group we work closely with client’s staff to satisfy each specific client requirements during the validation process. Our protocols include customized validation approaches and methodology with clearly defined pre-determined acceptance criteria. We offer fast documentation turnaround and can often schedule validation projects with short lead times.
Clear Benefits Principle benefits include reduced cost and time
to achieve a compliant system. We use a integrated approach to commissioning
and validation activities, ensuring at all times cGMP compliances.
We offer full validation cycle services associated with manufacturing projects as well as offer services to retrospectively validate existing manufacturing processes.
We can assist you with interpretation of regulations in determining the validation requirements; manage implementation of methodologies and prepare necessary reports.
Our strengths
Services
Regulatory
Engin
eeri
ng
Training
IT
DifferenceKnow
Sen
se
Integration
Med
ia
Hand to Hand
Trade
Our People
Experience
Ded
icat
ion
Healthcare Ser
vice
Ori
ente
d
CODEX
