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.

1. VALIDATION
www.codexvalidationgroup.com
ENGINEERING
STAFFING

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.

6. Codex Validation Group
Organizational CHART
Company Officers
Human Resource
Accounting
Compliance
Engineering IT
Validation

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

10. Technical Expertise Regulatory
Compliance/Validation (Continued)
 Standard Operation Policies
 Process Improvement and Operating Procedures
Development
 Virtual Process/Network Qualification

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

13. Qualification Expertise
Computer Qualification
 SCADA  LIMS
 PLCS  Maximo
 Virtual Network  Batch
 Remote Access  EBI
 Servers Qualification  SAP
 Network Qualification  MES

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

17. Equipment Qualification Expertise
(Solid Dosage Form & Parenteral)
 Lyophilized  Compressing Machines
 Filler  Coating Machines
 Stopper  Encapsulation Machines
 Autoclaves  Cream Tanks & Lines
 Fluid Bed Granulators and  CIP/SIP Skids
Dryers  Dust Collectors
 Tablet Inspection Vision  Ovens
System
 Dryers
 Blenders

18. 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

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

24. Regulatory Expertise
 FDA
 ISO
 OSHA
 ISPE
 KFDA
 European Medicine Agency (EMA)

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.

28. Our strengths
Services Difference
Our People

29. CODEX

30. 787.549.8192/787.544.7509
w.acevedo@codexvalidationgroup.com
www.codexvalidationgroup.com