Learn how QbD Group helped a biotech CDMO close CAPAs across Quality Assurance, Qualification & Validation, and Software, strengthening GMP compliance and audit readiness.
QbD Group supported a biotech CDMO in strengthening its GMP compliance by successfully closing all planned CAPAs across Quality Assurance, Qualification & Validation,and Software. This hands-on, risk-based support ensured sustainable improvements in processes, documentation, and regulatory readiness, helping the client reduce risk and enhance overall operational quality.
The client needed to effectively close several open CAPAs stemming from internal audits and regulatory requirements, within a highly demanding GMP environment.
The main challenge was implementing robust and sustainable solutions across Quality Assurance, Qualification & Validation, and Software, within tight deadlines, while minimizing regulatory risk and meeting the expectations of health authorities.
QbD Group provided end-to-end GMP support, working closely with the client’s teams across QA, Qualification & Validation, and Software.
The approach included:
Developing master documents and SOPs from scratch, and improving existing SOPs
Optimizing key processes and addressing audit-related deviations using risk-based tools
Ensuring continuous follow-up until final CAPA closure, guaranteeing long-term sustainability
This practical, collaborative approach ensured full compliance and measurable improvements in the client’s GMP systems.
The project achieved 100% closure of planned CAPAs, with all corrective and preventive actions meeting GMP requirements and regulatory expectations.
As a result, the client significantly reduced regulatory risk, strengthened quality, validation, and software systems, and improved audit and inspection readiness.
QbD Group’s support was instrumental in effectively closing our CAPAs and strengthening our GMP systems. Their hands-on, risk-based approach enabled us to implement sustainable solutions and significantly improve our regulatory readiness.
继续阅读
成功案例A non-profit lab organization unified its quality management processes by implementing a validated SAAS QMS, enhancing compliance and efficiency across departments.
阅读更多
成功案例Discover agile validation support for life sciences, enhancing compliance and efficiency through a scalable, on-demand model tailored to your IT validation needs.
阅读更多
成功案例Discover how QbD Group helped a pharmaceutical facility in Barcelona optimize and validate a complex autoclave load, improving sterilization efficiency and manufacturing flexibility.
阅读更多