CODEX Validation Group, is offering Pharmaceutical, Biotechnology, Medical Devices, and Chemical Industries a range of services, that ensures efficient and cost effective results. We have ensured that all the services we provide are in the circle FDA, and other international agencies have set.

We are offering you a total regulatory compliance, and validation service. Validation includes planning, commissioning, and qualification related activities; that will include equipment qualification, software validation and computerized system, process validation, analytical methods validation, and cleaning validation. We have a number of experts in our team, who are specialize to ensure that FDA and ISO requirements are being met.

CODEX Validation Group works closely with our clients, to ensure that they are receiving the service they deserve. Our validation process is based on GLP, GMP, GAMP 5, ISO, and 21 CFR Part 11 regulations. Our validation process includes:

REGULATORY COMPLIANCE

Risk Assessment

Investigations

CAPA

Audits

Material Qualification

SOPs development and Verification

Process Capabilities

Equipment Validation

Cleaning Validation

CSV &Automation Support

Impact Assessments

SDLC

Facilities Qualification

ENGINEERING

Project Capital and Cost Management

System Requirement Analysis

Implementation

Schedules

Commissioning

Factory Acceptance Tests

Site Acceptance Test

Design of Experiments (DOE)

Capability Indices/Process Capability Evaluations

Cause & Effect Evaluation

Analysis of Variance (ANOVA)

TRAINING

GMP Training

CSV Training

Document Management

Data Integrity

Standard Operating Procedures (SOPs) Development

DOE for new comers

Quality Risk Management

STAFFING

Engineers
Information Technology
Automation
Laboratory

AUTOMATION

HMI development and migrations

PLC / HMI troubleshooting

Control Panel Construction
Camstar Enterprise Platform Support
Network and Infrastructure
Databases Design

EQUIPMENT RENTAL

Data Loggers
Kaye Validators

CVG Certification

CVG Group is certified by the Puerto Rico Minority Supplier Development Council. “Minority Business Enterprise”

Our Services

  • Regulatory Compliance

  • Engineering

  • Training

  • Staffing

  • Automation

  • Equipment Rental