Syprosoft Engineering has helped many clients implement or update their quality system processes to comply with the latest governmental requirements. Even a small start-up has to have a quality system that is compliant with the regulations. Syprosoft Engineering can put together a system that is customized to the client’s operations and that adds no extra burdens or only minimally so. Below is the top-level organization chart for a small medical device company with outsourced manufacturing that we developed the quality system for.
- The quality system typically includes the following processes:
- Quality System Requirements
- Design Controls
- Document Control
- Purchasing Controls
- Identification and Traceability
- Production and Process Controls
- Acceptance Activities
- Nonconforming Product
- Corrective and Preventive Action
- Labeling and Packaging Control
- Handling, Storage, Distribution & Installation
- Records
- Servicing
- Statistical Techniques
You don't have to re-do all of your existing documentation to comply with the FDA's new risk-based framework. We will instead morph your current documentation to comply with the new regulations in record time and at minimal cost to you. Turn this project over to us.