Our way of working – The Project Plan

Few industries are more exposed to risk than the life sciences and medical industries, as issues with quality or patient safety can result in very high legal claims. That’s why our consultants, engineers and other experts offer specialized knowledge, expertise and software in the fields of validation, quality assurance, regulatory affairs, clinical and project management. In our activities, we always work with a risk-based, project plan approach, focusing on what’s really important. This way, we increase efficiency, reduce workload and total compliance costs while guaranteeing optimal quality, safety and compliance of products.

As a full-service partner, QbD supports you in a flexible way – from small issues to large projects. Our project plans and services vary from short-term and long-term consultancy to a Quick Scan, taking care of complete projects or working together according to our unique Academy Model.

Consultancy

Over 300 experts are ready to advise and support you in the field of validation, regulatory affairs, quality assurance or project management and support. You can entrust your project to our consultants and rely on their skills.

  • Giving advice
  • Knowledge & expertise

Projects

We take care of your short and long-term projects in the field of validation, regulatory affairs, quality assurance and project management and support. This accounts to both validation and documentation projects.

  • Quick Scan
  • Working on scope
  • Delivering clearly defined results
  • Specific time frame
  • Estimated budget

Outsourcing

QbD advises companies – both small and large – on efficient and cost-conscious outsourcing. The outsourcing process always involves a certain transfer of documented technological expertise, processes, assets, and sometimes, even employees between your company and another external party.

  • Take over responsibility
  • Take away customer concerns

Software

Get your quality processes under control and make your life easier, with the most comprehensive Quality Management Software on the market. 

  • eQMS software
  • Document mgmt.
  • CAPA
  • Change mgmt.
  • Training
  • EBR

Academy Model

We offer highly educated young professionals for your temporary projects. They receive relevant training, while gaining on-the-job experience. For you, it’s the perfect way to efficiently manage projects and resources and you get the chance to hire the trainee yourself after 14 months.

Auditors

Within any regulated quality system, an audit process is required for its approval. This includes both internal and external audits. 

Quick Scan

Our Quick Scan includes a thorough on-site risk assessment of your ISO and GxP compliancy. The result is a detailed report, including problem definition, gap analysis and CAPA list with critical actions, which you can tackle alone or with QbD.