Quality Management and Compliance and Quality as a Service
Gaea is boutique CRO, but we have made significant investment in our QMS (quality management system) and Learning Management System (e-LMS).
We also offer “quality as a service” to our smaller/ start up clients:
Drugs
We have written a company-specific QMS for a
• A Swedish biotech client with few staff but already in clinical.
• A Bangladesh CRO working in paper and employed our LMS provided staff training.
• An Estonian biotech moving into pre-clinical and keen to ensure they have an initial basic QMS in place.
We can provide advice and effective action as a CRO or as an FSP:
- QMS elements development ( write your organisational specific SOPs, Wis, Policies, manuals, etc.).
- QMS management (GxP cases, issue management, CAPA management and internal process audits).
- Learning Management System ( eLMS) setup and management or assistance in this.
- Provider selection assistance.
- Software selection and validation or assistance in this.
- Independent quality review of project documentation.
Medical devices
We have written a company specific QMS for an EU MD company in sepsis.
We work with a smart US agency for the evolving regulation such as ISO62366 update is coming and the associated new FDA Guidance, and we manage the agency delivery.
As a taster: the FDA will only approve devices that are designed so that it is practically impossible for people to harm themselves, even if they use the device improperly or accidentally.
The FDA has replaced “user error” with “use error.” This means that the FDA considers user error a device nonconformity because human factors should be considered in the design process. The burden is on the device designer to create an “idiot-proof” product.
The EU MDR also needs expertise to help any small company, for example we can help here:
- The QMS is a most important task for any device company to have in place before the development starts.
- The Technical Dossier first-pass accuracy and completeness is essential.
- The trial primary endpoint/s must be clinically relevant to a patient and ECs recommend minimum exploratory endpoints as without statistical power these just create “noise.