Codex Validation Group is an engineering staffing and validation services company founded in Puerto Rico by professionals with over 25 years of combined experience in the pharmaceutical industry. The company provides validation, engineering, IT, and regulatory compliance services with a focus on computer and automation system validation. Its team of experts have experience across the product development lifecycle from process engineering to packaging and equipment qualification. The company aims to become a leader in technical services and regulatory compliance solutions for manufacturing clients.
2. 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. )
3. 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.
4. Mission
OurMission 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.
5. 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.
7. 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.
8. 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
Engineering Regulatory
Resourcing
9. 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
11. Automation Qualification
Expertise 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
12. Automation Qualification
Expertise in System Development Life Cycle (SDLC)
Documents Preparation (Continued)
System Level Impact Assessment
Part 11 Assessments
Criticality Assessment
Validation Reports
14. 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)
15. Qualification Expertise
Purified Water system
(Commissioning & Qualification)
RO
Vapor Compression
CDI
USP Loop System
WFI Loop System
Water Distillation System
16. Qualification Expertise
Compressed Air System
(Commissioning, & Qualification)
Dryers (Refrigerant & Desiccant)
Air Compressor
Distribution System
Clean Steam
Process Air
19. 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
20. 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
21. 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
22. 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 Plans
FAT
SAT
Job Plans
Project execution planning
Scheduling
Start-up / Commissioning/Factory Acceptance
Test, /Training
23. Computerized Maintenance Management Solution
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
25. 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.
26. 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.
27. 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.