Category: White Papers

ICH Q10 is a comprehensive model for a pharmaceutical quality system that can be implemented throughout different stages of a product lifecycle.
The aim is to establish and maintain a state of quality control and to facilitate continual improvement.
Implementing well defined, integrated processes that work within the culture of the organisation is paramount.
Implementing an automated solution can greatly increase the chances of success.

ICH Q8(R2) provides a quality risk-based framework for Pharmaceutical Development companies to implement in order to design a quality product and consistently manufacture to the intended performance of the product.
The outcome is enhanced knowledge on the product and the process.
As much data is collected, analysed and disseminated, an automated system that records and controls the development process greatly enhances the chances of successful compliance.

Introducing a new Medical Device onto the market a number of well defined risk analysis and evaluation phases should be undertaken. Risk Management and the performance of Risk Assessment are crucial parts of the design, development and control process.

Risk Assessment is a valuable tool and a regulatory expectation that should be used throughout the whole of the product life cycle to ensure a safe and effective product.

There is no silver bullet to ensure that your validation projects will be successful, but using a structured methodology and a science based risk assessment process, the chances of determining the correct ordering of activities will be greatly enhanced.