Quality Risk Management

A risk-based approach to Quality Management is becoming more and more important because of changes in the regulatory environment, and the increased complexity of clinical studies. Innovative approaches to clinical development are a clear driver, as well.


In addition, safety data and an increasingly high compliance level in reporting safety data and information (e.g. PSURs, the new DSURs, Spontaneous Cases) are more and more the focus of regulators: raw data as well as meaningful summarised information on side effects must be made available to Health Authorities and the public in the fastest and most reliable manner possible. Thus, a new approach to managing consistency and maintaining a high level of process integrity and compliance with regulations is crucial to the success of any healthcare provider, from big Pharma to small Biotech or Academia. The challenge is to react to errors early enough to be able to correct them before they turn into bigger problems or even a failure causing loss of time in the development process, significant costs to fix the aftermaths of a failure, and loss of reputation/market share for the organisation. In addition, a robust Quality Management System ultimately leads to process improvements, and measures that will prevent the process in question from failing again in the future.


How can Widler & Schiemann assist you with your QRM projects?
Widler & Schiemann are thought leaders in the industry regarding the QRM concept and approach. They both have extensive experience in the design, configuration and implementation of QRM concepts. Widler & Schiemann can help you with any phase of your QRM project from initiating the thought process and change management steps critical to success, to fine tuning an already implemented QRM methodology.

Widler & Schiemann will work with your experts and process owners to deliver a QRM solution that fits your needs. When starting from scratch, the first thing to do is to analyse the processes in question to get an insight into their critical steps and how to measure them in a meaningful manner. As a result, Key Risk Indicators (KRIs) will be defined or existing ones adapted to the needs of your organisation and processes put into context to ensure that process owners are alerted in time to enable them to initiate corrective measures efficiently. Since KRIs use a large amount of data, it is advisable to run this assessment on a computerised platform. Widler & Schiemann can assist with user requirements for such a system and point you to proven service providers to support your efforts and even host the systems. Finally, reports for all levels of management are an essential tool to inform the responsible individuals about risks in studies in their development portfolio, as well as in their pharmacovigilance processes. We will also work with you on the critically important change management aspects of this novel approach to Quality Management. Since roles, responsibilities and priorities can change significantly during this process a change management concept supported by senior management is key to success.

Download as PDF
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /