The importance of a Risk-based approach for Quality Management Systems

Jun 15, 2017 | Quality Management

With the new ICH GCP E6(R2) addendum in effect from June 14, 2017, seQure, a business unit of Arithmos, would like to highlight:
“The importance of a quality management system managed through a risk-based approach”. 
The new addendum is the largest revision of the ICH GCP Guidelines over the past twenty years and it is fully supported by the European Medicines Agency (EMA). Previously, these guidelines were optional and the addendum now makes mandatory some activities related to Quality Management.
The sponsor is required to implement a system to manage quality throughout all stages of the trial process. Through a risk-based approach, the assurance of quality should be proportionate to the risk inherent in the trial and the importance of the information collected. The Sponsor should focus on trial activities essential to ensuring human subject protection and the reliability of trial results.

A quality management system that is based on risk should be applied as follows:


1. Critical processes and data identification: what processes and data are critical for the patient’s safety and for the reliability of results
2. Risk identification: the sponsor should identify risks to critical trial processes and data
3. Risk Evaluation: the sponsor should evaluate the identified risks
4. Risk control: the sponsor should decide which risks to reduce and/or which risks to accept
5. Risk communication: the sponsor should document quality management activities
6. Risk review: the sponsor should periodically review risk control measures
7. Risk reporting: the sponsor should describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in the clinical study report

In addition, the new addendum makes it clear that responsibility for “non-compliance”, , with GCP regulations, written procedures and the protocol lies with the Sponsor.

Given the complexity and the high level of experience required by this new approach, it becomes important for the sponsors to have a qualified and expert Quality Management System able to guarantee a complete service and adherence to the guidelines and ICH GCP introduced by the EMA.

How can seQure, a business unit of Arithmos, support you with pharmacovigilance?

With over 20 years of experience in the Quality Management field for Life Sciences, the seQure team can support you in the implementation of a QMS system through a risk-based approach by providing the following services:

  • Implementation, analysis and improvement of the Quality System
  • Standard Operating Procedures (SOPs)
  • Preparation and support for Audits and GxP Inspections

About Arithmos

We are Business and Technology experts in the Life Science industry.

We help companies to gain the best business value through technology-enabled solutions. With our business units seQure and The CQA Company, we provide Quality Compliance and Consulting services.

We deliver solutions and services for:

  • Pharmacovigilance and Safety
  • Regulatory Document Management
  • Reporting & Analytics
  • eClinical
  • Cloud Services
  • IT Services
  • Quality Management
  • Computer System Validation
  • Regulatory Affairs

Our industry-leading experts combine the knowledge of processes and technologies to implement your digital strategy, enable rapidly scale-up along with fulfilling oversight, governance, and compliance requirements.

We support your:

  • Digital Transformation
  • Business Process Re-engineering
  • System Integration
  • Data-Driven Management

Contact us now!

If you would like to learn more about our services or receive a free assessment, please fill out the form. We will get back to you as soon as possible.

Contact us now!

If you would like to learn more about our services or receive a free assessment, please fill out the form. We will get back to you as soon as possible.