Quality Management Systems

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At GCC, we help our clients to develop Quality Management Systems that standardize current processes and address gaps to ensure consistent, accurate and reliable standard procedures across all business functions that are compliant with global regulatory standards. We do not offer an off-the-shelf product. All QMS projects are customized for each client based on the current business, risk-assessments, and future business plans to allow growth of the system while maintaining compliance. GCC has the experience and ability to either build a QMS from scratch or instead incorporate existing documentation/systems into a more controlled and compliant QMS.

 

A Quality Management System is a set of processes expressing an organization’s goals, policies, procedures, information and resources required to implement and maintain it. An organizational QMS focuses on meeting customer or regulatory requirements, and maintaining consistent predictable outcomes. QMS processes include order processes, production plans, internal audits, CAPA, and vendor selection and management.

 

Since finalization in 1996, the guideline for Good Clinical Practice E6(R1) developed by the International Conference on Harmonization (ICH) has provided clinical trial research a set of procedural standards to protect human subjects and ensure quality of data.

 

With the shift towards electronic records, data capture systems and risk management over the past 20 years, the ICH has modernized and redefined the responsibilities of individuals involved in clinical trials and clarified the processes involved with the release of the 2016 addendum ICH GCP E6(R2). A number of the GCP changes in E6(R2) have significant impact on existing operations performed by sponsors, CROs and clinical sites.

 

Perhaps the most impactful GCP change required by sponsors is Section 5.0 – Quality Management, which states that sponsors need to have a quality system in place, and stresses the importance of a risk-based approach. The basic ideas of this risk-based approach are emphasized in the statement “The methods used to assure and control the quality of the trial should be proportionate to the risks inherent in the trial and the importance of the information collected.” The subsections go on to emphasize the importance of a risk-based approach throughout the clinical trial process. The benefits of the Quality Management System Initiative include enhanced patient safety by improving quality, assuring data integrity, minimizing delays in clinical trials and bringing drugs or medical devices to market more quickly.

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And the changes to GCP don’t end with the E6(R2) addendum. More changes are planned with yet another renovation of E6(R2) in addition to the modernization of the 1997 ICH E8 guideline  (general considerations for clinical trials) that are expected to add flexibility to the range of clinical trial types accommodated under GCP.

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