Achieving efficient compliance
Just like Operational Excellence ensures a perfect fit between product quality and efficiency, the state-of-the-art Quality Excellence approach must go beyond pure compliance requirements to additionally fulfill efficiency demands. Our understanding of Quality Excellence covers all aspects of quality management, including organizational design, quality strategy development, quality risk management and audit & inspection. It considers quality control, product quality assurance, systems quality assurance and the interfaces between these domains.
Some questions Quality Excellence can answer:
- How can we ensure our organization effectively manages regulatory intelligence?
- How can we sharply structure our change control system to efficiently interlink validation documentation updates and batch release?
- How can we implement an efficient SOP landscape, and compliant documents control procedures that are nevertheless intuitive and easy to handle?
- How can we introduce a continuous process verification system and combine it with periodic product quality reviews?
- How can we implement a role-based training system that permits to efficiently allocate SOPs and training content to employees and allows on-the-fly checks of training completion KPIs?
How to uQualize+ your business
In the fast changing regulatory environment we support you in identifying the standards of compliance you need to adhere to, based on WHO and national compliance standards as well as common industry practice:
- Analyzing the gaps to identify quality enhancement goals to set
- Rating the implied reduction in quality risk
- Developing an action road map for operational excellence or remediation of quality gaps
- Achieving continuous improvement in your quality management system through process excellence, organizational design and technology
- Providing you with single-source-tracking solutions to steer your enhancement programs and projects
- Implement a continuous quality risk management process
- Introducing management system owners to ensure quick and effective evolution of your quality system and compliance standards