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
Investigations
CAPA
Audits
Material Qualification
Process Capabilities
Equipment Validation
Cleaning Validation
Impact Assessments
SDLC
Facilities Qualification
ENGINEERING
System Requirement Analysis
Implementation
Schedules
Factory Acceptance Tests
Site Acceptance Test
Design of Experiments (DOE)
Cause & Effect Evaluation
Analysis of Variance (ANOVA)
TRAINING
CSV Training
Document Management
Standard Operating Procedures (SOPs) Development
Quality Risk Management
STAFFING
AUTOMATION
HMI development and migrations
PLC / HMI troubleshooting
Camstar Enterprise Platform Support
EQUIPMENT RENTAL
CVG Certification
Our Services
Regulatory Compliance
Engineering
Training
Staffing
Automation
Equipment Rental
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CETA Building Road # 2 Km. 59 Interior Bo. Florida Afuera Barceloneta,
Puerto Rico 00617