Quality Assurance
At Eden Biodesign, we comply with regulatory requirements and best industry practice to ensure the right outcome, whether it is for process development, analytical testing or clinical manufacture of Investigational Medical Product.
Our systems are flexible enough to support the varied needs of our clients, yet robust enough to ensure that the facility maintains regulatory-compliant control over all projects.
From receipt of your starting material to shipping out of your product, Quality Assurance is central to all our operations – driving home our programme for continual improvement.
Eden Biodesign can translate your process and analytical information into a Product Specification File and update it with the progress of your IMP. We welcome your audits and aim to be as transparent as possible. As it says in our quality statement, all our staff are responsible for quality.
Our activities include:
- Training
- Facility, supplier and 3rd party audits
- Document control
- Change control
- Batch record compilation and review
- QP release
