Design Study

Quality systems for the pharmaceutical, healthcare, medical device, cosmetics and food industries must comply with ever-stricter regulations, quality standards and guidelines, like ISO 13485 and GxPs, such as GMP. Organisations often struggle to guarantee that their products meet all requirements. That’s why QbD offers a thorough on-site risk assessment of your ISO and GxP compliancy by means of a Design Study.

Many quality professionals in the industry are experiencing the pressure: Do we comply with all regulatory requirements? Can we make our quality control systems more efficient without compromising on performance? Should we validate all IT systems? Which modules of our ERP-system are critical for GxP compliancy? How can we improve the integration of our quality control system with our production processes? How can we lower our total compliance costs? Our Design Study offers help.

The Design Study is an essential part of our working method for our clients. It consists of the following steps:

  • Preparation: our consultants study relevant material, identify the relevant stakeholders within your organisation and develop an assessment agenda.
  • On-site gap assessment and interview stakeholders: we interview your stakeholders, perform a high-level risk analysis and carry out the on-site assessment.
  • Drafting and presentation of report: after a detailed end analysis we write a detailed report, including problem definition, detailed gap analysis and CAPA list with critical actions. Based on the urgency of the actions, we prioritize the actions in a capability maturity plan.
  • Project execution: together we discuss the next steps. QbD can support you on every level, from delivering the project plan and a subject matter expert to coaching your team or taking care of your whole project, with a team of senior project managers and junior engineers.

What do we validate?

All computerized systems that have an impact on product quality, patient safety and data integrity. Adequate CSV consists of various aspects – from planning, system verification and validation to testing, traceability and configuration management. This applies to the validation of product or device software, as well as to the validation of software used to design, develop or manufacture devices and products.

Interested in our Design Study?