Practical & Compliant Quality Systems
Quality System Implementation. We assist clients with the implementation of practical, compliant, Quality Systems that are sustainable for companies of all sizes and in all phases of development. Some of our clients are in Phase 2 or Phase 3 clinical trials, while others have large scale manufacturing capabilities with international distribution networks. Regardless of your size, we can build the quality system that is the right fit for you.
We routinely provide assistance with:
- New Quality System Development
- Remediation of an existing Quality System
- Complaints (MDR/ Vigilance Reporting)
- Corrective Action and Preventive Action (CAPA)
- Change Management
- Management Review & Annual Product Review (APR)
- Facilities Review
- Equipment: Maintenance, Calibration, Cleaning, and Life Cycle Management
- Controls for: Components and Raw Materials
- Production / Process Controls: Procedures, Sampling, Testing, and Processing
- Packaging and Labelling Controls
- Warehouse and Distribution
- Stop Shipment, Recall, and Field Actions
- Laboratory Controls: Release Testing, Stability Testing, and Sample Management
- Records: Log Books, DHR, DMR, DMF, Other Quality Records and Data
We implement high Quality Systems for products in the US, EU, Canada and Asia.
Some of Our Work
Quality System for an Inhalation Product
Our Client 1
We developed a quality system for an inhalation product that is adaptable for both clinical and commercial operations.
Quality System for an Injectable Product
Our Client 2
We implemented SOPs, forms, along with a quality manual, management review, and training program for a manufacturer of injectable products.