Are you looking to improve your Quality Management System (QMS)? Do you want the best solution for your quality needs?
QbD offers you expert support to implement or execute all, or part of your QMS.
Don’t hesitate to contact us for more information about our Clinical QA services.
What is Clinical QA?
As a company, you have to comply with rules and regulations. Regulators expect companies to have a robust QMS in place. A QMS includes a system, procedural documents, training, as well as elements of issues/deviation management, CAPAs, inspection readiness, etc. Executing audits on any of the QMS elements is an integral part of good quality management.
A robust QMS supports your company in maintaining control over the quality of the services and activities you perform. It significantly contributes to bringing safe, reliable products to market, supporting the health and wellbeing of patients in need.
QbD Clinical has the experience and expertise to support your company in the creation or execution of (part of) your QMS, fitting for your organization and adapted to your needs.
Why QbD Group?
At QbD, we strongly believe in a QMS that is adapted to the purpose, pragmatic but still in line with what regulators expect. Our experts have the capability to match the expectation to your reality.
What clinical QA services do we offer?
We give tailored advice for any aspect of the creation or maintenance of your QMS.
For longer-lasting or more complex requests, a dedicated resource may be identified.
Although we always tailor our services to the needs of the client, when you request our support for the creation or maintenance of your QMS, we take the following approach:
- A quick scan: an assessment of your current QMS against current expectations
- An analysis of the gaps (if any) with a proposal for improvement
- Closing the gap
Our audit services specifically consist of the following phases:
- Preparation phase: getting to know your company
- Execution phase: the actual audit takes place. This typically includes document review and interviews. This can be on-site or virtual.
- Follow-up phase: an analysis of what was observed during the preparation and execution phase. Was it in line with the expectations? You will receive a report with a list of findings, and if desired, we will do a debrief and/or give an overview of the lessons learned.
- Yes! QMS does not have to be synonymous with heavy or rigid. A QMS can be adapted to the needs of the company, as long as certain minimal expectations from regulators are met.
Contact us if you have any questions regarding our clinical QA services.