|
CQS Innovation, Inc.
2390 Pipestone Road
Benton Harbor, MI 49022
CONTACT:
Chris Roerig - V.P., Sales and Marketing
Tel.: (800) 860-1968
Fax: (269) 926-6854
Email: sales@cqsinnovation.com
Terms of Use
|
|
As a leader in innovation, CQS Innovation provides validation services for computer systems and automated manufacturing processes within pharmaceutical and nutraceutical companies worldwide. We understand the pivotal importance of a manufacturing environment that meets current GMP requirements. Our staff of professionals can help ensure all elements of your manufacturing process are in compliance with FDA regulations.
Through proven methodologies, we focus on compliance with regulatory requirements, including:
- cGMPs (21CRF Part 210 and 211)
- Electronic Records and Signatures (21 CFR Part 11)
- Quality System Regulations (21 CFR Part 820)
Utilizing our analytical and project management strengths, CQSI provides a full range of testing capabilities, as well as Master Plan preparation and Protocol Design/Execution. Our capabilities include:
- Validation Project Management/Coordination
- Protocol Development for
- Design (DQ)
- Installation (IQ)
- Operational (OQ)
- Procedure Writing
- System/Equipment Qualification
- Vendor Audits
- Master Plan Preparation:
- Document Preparation
- Standard Operating Procedures
- Protocols
- Test Records
- Consultation
- System Validation:
- Project Management
- Test Protocol Preparation
- Control Equipment Qualification
- Analytical Testing
- Data Interpretation and Report Preparation
- Application Areas:
- Automation Systems
- Level 0 - Systems/Equipment
- Sensors, single loop controllers, activators
- Level 1 - Controllers
- Real-time embedded controls, PLCs
- Level 2 - Workstations
- DCS, environmental controls, SCADA
- Level 3 - Area wide production managment systems
- Level 4 - Facility, MRP, ERP, document management
- Facility/Equipment/Process
- Bulk Pharmaceutical Chemicals, Active Pharmaceutical Ingredients (APIs)
- Solid, Semi-solid and Liquid Dosage Form Manufacturing
- Blow/Fill/Seal
- Granulation, Mixing, Tableting, Capsulation
- Filling and Packaging
- Parenteral Manufacturing
- Clinical Material Samples
- Medical Devices and Diagnostics
- Cleaning and Sterilization
- Analytical Laboratory Equipment
- HVAC
- Clean Rooms
|
