Hospitals and other healthcare parties need to comply with a growing set of standards to guarantee patient safety. This results in an increasing amount of separate procedures and additional pressure on medical staff.
As quality expert, QbD has plenty of experience in healthcare quality control. From medical tech transfer to quality control of medical devices: we support hospitals, laboratories and other healthcare parties. Many of our clients are working on innovative new technologies, like stem cell technology.
We support them in validation of processes and equipment and during tech transfer between various parties. Moreover, hospitals and other healthcare companies are often dealing with a host of different quality management systems (QMS) within their organization, all with their own specific standards. QbD offers an electronic Quality Management System via QbD Software. That system is compatible with the different quality standards valid within health care, like for example the ISO15189 standard.
Consultancy in healthcare-companies
From our offices in Belgium (HQ), the Netherlands, France, Spain, the US, Mexico and Colombia, more than 180 QbD consultants help companies that develop and produce pharmaceuticals to control quality risks during development, production and distribution. We do this by providing consultancy in the following fields:
- Validation and Qualification:
- Equipment Validation
- Cleaning Validation
- Software and Hardware Validation
- Process Validation
- Method Validation
- Computer System Validation
- Quality Assurance (QA outsourcing)
- Regulatory Affairs
- Quality Management
- Quality Management Systems
- Quality Management Software
- Qualified Persons (QP outsourcing)
- Project Management & Support
- Tech Transfer