Quality Management

The ICH guidelines on Good Clinical Practice (GCP) E6, particularly Section 5, require the establishment of quality assurance (QA) and quality control (QC) procedures for clinical trials.
It is the sponsor's duty to develop and uphold QA and QC systems, which should be governed by written Standard Operating Procedures (SOPs). These systems are designed to ensure that clinical trials are conducted, and that data is generated, documented, and reported in accordance with the protocol, GCP, and relevant regulatory standards. The quality management system should incorporate a risk-based approach to enhance the efficiency and effectiveness of these processes.

The Quality Management division extends its expertise, developed through the maintenance and continuous improvement of our ISO-certified Quality Management System (QMS), to support external clients. We provide consultation and assistance in implementing QA and QC measures, particularly in developing and documenting Standard Operating Procedures.

Our Services

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QMS Setup Assistance We offer tailored consulting services on implementing robust quality assurance and quality control measures for your individual trial or on an organizational level.
Development of Standard Operating Procedures (SOPs) We support you in identifying the necessary (risk-based) Standard Operating Procedures (SOPs) and ensuring their proper documentation by supporting you in drafting, reviewing, and updating SOPs.
Internal Audit Conduct
 We provide guidance on internal audit initiatives, which are independent of and separate from routine monitoring or quality control functions. These audits aim to evaluate the effectiveness and compliance of the processes implemented to manage and conduct the trial.
External Audit and Inspection Support We assist in preparing for regulatory inspections or external audits to help ensure that all necessary preparations are made and that your team is well-equipped for the inspection process.

Note on Liability: When the QM Team provides support to a study team in preparing for regulatory inspections or external audits, it is important to understand that while we offer comprehensive assistance and guidance, we do not assume liability for any findings or outcomes of the inspection. The ultimate responsibility for compliance with regulatory requirements and the rectification of any findings lies with the sponsoring organization and study team.
Addressing Inspection Findings (CAPA) We assist in creating and implementing a Corrective and Preventive Action (CAPA) plan, addressing all inspection findings, and ensuring submission to the appropriate authority.