Risk Management

Addressing your risk management needs

Many companies now recognise the need to identify, assess and control risks to the quality of their products and services. This trend has increased with the introduction of the Sarbanes-Oxley (SOX) act in 2002 (USA) and the move of various pharmaceutical and related regulatory agencies to address risk analysis and risk assessment across the product life-cycle. However, the concepts of risk management are often poorly understood and suffer from a lack of a systematic approach.

PAC can help you to implement a consistent quality based risk management process to improve your business processes, within clinical research, product development or manufacturing.

Computerised System Compliance

With PAC’s experience in computerised systems validation, we are in a unique position to develop and integrate QRM activities into effective validation solutions that are commensurate with the level of risk.

Product Development

Although risk management concepts are well understood in the product development process, a good QRM approach will reduce subjectivity during scale-up and will allow companies to focus on the areas of greatest risk to manufacturing efficiency, product quality and patient risk. Working with its network of industry experts, PAC can help to implement the necessary QRM infrastructure necessary for full scale production.

Clinical Research

Whilst many companies have been addressing the needs of SOX in respect to managing their portfolio, not many companies have yet realised that a Quality Risk Management (QRM) approach can have significant advantages in managing a clinical trial process. A well structured QRM approach will not only help to minimise costs and protect the patient, but can increase transparency within the organisation and can help build trust with outside agencies. PAC can guide you through this process.

Manufacturing

Whilst a QRM approach to qualification is well understood, the implementation of a QRM approach is often not consistent and integrated within the pharmaceutical manufacturing quality systems. Working with its network of industry experts, PAC can help facilitate the move to an open, risk aware culture.