Our experienced team draws on years of experience in Quality Management & can assist you in creating, updating or optimising your Quality Management System to ensure that it fulfils all regulatory requirements while enabling your organisation to work efficiently.
GXP Engaged Auditing Services was requested to conduct a review of the existing process landscape of the sponsor to identify opportunities for process improvement, streamlining of processes and interfaces, elimination of redundancies and identification of process gaps. The project was conducted in two phases:
The first phase included an analysis of the current situation:
The second phase included the definition of re-designed processes and creation of the new process landscape:
Key success factors for this project were:
GXP Engaged Auditing Services was contracted to support a process improvement initiative for existing processes and procedures in Clinical Development. As part of this, each SOP governing clinical development processes was reviewed by GXP Engaged Auditing Services and discussed with the process owner or other key stakeholders of the client, with the goal to identify gaps and redundancies in the processes, assess the compliance with regulatory requirements and ensure alignment with the existing organisational structure of the client company. The result of the project was a Gap Analysis Report outlining identified deficiencies and gaps for each SOP and for the process landscape in general.
As a follow-up project, support in updating specific SOPs identified by the client was provided by creating a first draft of revised SOPs and support of the client until issuance of updated SOPs addressing the deficiencies identified in the first part of the project.
GXP Engaged Auditing Services was requested to conduct a GCP GAP assessment on a recently completed clinical trial to provide information to support the sponsor’s inspection readiness activities. The objectives of the GCP assessment, were:
The review included:
A summary report with high level recommendations was provided following the GCP GAP Assessment that included recommendations for follow up that could be included as part of future inspection readiness activities, such as focused visits to the investigator sites or actions for sponsor/third parties.