When you’re working in the life sciences, healthcare or cosmetics industries, it’s a fact that regulations and inspections are becoming stricter for everyone – both large and small companies. A thorough quality management system (QMS) – on paper or supported by IT systems – helps you comply with current and future regulations. It also has various other aims, including setting up and maintaining optimum control of your quality, in addition to stimulating continuous improvement of product quality.
QbD sets up and optimises your QMS, prepares your company for internal and external audits and provides training programmes on GxP and validation. With a risk-based approach and in a pragmatic, structured way, our team of seniors, mediors and juniors helps you to organise and optimise systems, such as:
- control systems for operational processes and for monitoring process performance and product quality;
- systems for Corrective Action and Preventive Actions (CAPA);
- systems for change management;
- management systems for identifying improvement opportunities, evaluating audits and CAPAs, and complaints management.
Based on this experience, we founded QbD Software, our own technological solutions developed especially for quality management in the life sciences, biotech and med-tech industries. QbD Software enables you to quickly build systems that are fully tailored to your specific needs and are in line with all software validation standards.