QMS Support

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:

• Review of each existing processes including a visualisation of each process as a process flow chart with identification of responsibilities, input, output and interfaces
• Creation of a cross functional process landscape depicting existing processes and interchanges to identify gaps, redundancies and overlaps displayed as a cross functional process map

The second phase included the definition of re-designed processes and creation of the new process landscape:

• Streamlining of the existing processes to create seamless end-to-end processes without gaps and redundancies, integrating existing technologies and visualisation of the new/enhanced processes 
• Re-write of existing processes including definition of key performance indicators and key quality indicators
• Creation of a new cross functional process landscape and map

Key success factors for this project were: 

• Correct identification of key stakeholders for each process
• Support by senior management to establish a re-designed process landscape
• Ability to convince all department members of the benefit of the project for daily work of each team member

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:

• Determine whether there were potential significant GCP compliance risks for key areas relating to the conduct of trial that would likely require further follow up as part of future inspection readiness activities. 
• Assess whether known GCP compliance risks identified during reviews and investigations for a previously completed clinical trial had been managed appropriately in the recently completed trial. 

The review included:

• Comparisons of listings e.g. from safety database and CSR listings to ensure that SAE information has been reported accurately.
• Comparisons of information recorded in Monitoring Visit Reports (MVRs) and the Case Report Forms (CRFs) vs. CSR listings (e.g. SAEs, discontinuations due to AEs, IMP dosing) to ensure accurate reporting. 
• Deviations in the CSR vs. Deviation Logs and deviations reported in MVRs to ensure major deviations had been reported appropriately in the CSR.
• Evidence that issues had been escalated appropriately and resolved when identified in MVRs or from other functional groups.
• Documentation to demonstrate that expedited safety reports and aggregate reports had been submitted on time to Regulatory Authorities.
• An indication that Statistical Analysis Plans and Data Management Plans had been followed or documentation was available for deviations, with explanations.
• Review of documentation relating to the previously completed trial investigation, to see if similar issues had occurred in the recently completed trial and if so, if action had been taken to address them.

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.