We supply accurate and predictable validation results based on customer needs in the medical device, biopharmaceutical and pharmaceutical industries by complying with CGMP and providing quality, prompt and assertive services with the highest standard.
We are
committed to quality services
ECDC Consulting Group, LLC can provide an efficient, effective documented plan that follows and complies with local regulations and guidelines to meet your project needs.
Our project life cycle experience ensures that commissioning and validation issues impacting on the design phase of a project are fully considered and integrated at the start of a project. We provide consistent guidance for product and process, design, equipment selection, commissioning, engineering studies or trials, qualification and process validation of manufacturing & packaging equipment that fits your goal.
We deliver product and process breakthrough results in the following project life cycle steps.
PLANNING
Costumer Wants Defines
Product-Process benchmark
Preliminary Product Specifications
Milestone plan
Preliminary Bill of Material
Preliminary Process Flow Charts, etc.
PRODUCT DESIGN DEVELOPMENT
Roadmap
Team Feasibility
Capability Assessment
Design FMEA
Tooling & Automation Design Review
Process Mapping
Critical Parameters
Process Documentation, etc.
PROCESS DESIGN DEVELOPMENT
Advance MSA
Reliability
Process FMEA
Statistical Analysis
Control Methods
Control Plans
Gage R&R, etc.
PRODUCT AND PROCESS VALIDATION
Commissioning (SAT & FAT)
Production Trials
Equipment Qualification (IOQ)
Process Qualification (PQ)
Safe Launch Procedures
Process Validation (PPQ or PV)
Transition Approval, etc.