IX.B.5. Quality requirements

Signal management is considered a critical process (see GVP Module I). Any signal management system should be clearly documented to ensure that the system functions properly and effectively, that the roles, responsibilities and required tasks are clear and standardised, that these tasks are conducted by staff with appropriate qualifications and expertise and that there are provisions for appropriate control and, when needed, improvement of the system. A system of quality management (see GVP Module I) should be applied to all signal management processes. Detailed procedures for this quality system should be developed, documented and implemented. This includes the rationale for the method and periodicity of signal detection activities.

Through a tracking system, all organisations should keep an audit trail of signal management activities, allowing traceability (i.e. recording of dates and confirmation of timeliness) and process control of the details of all steps of signal management, including analyses, decisions and rationale.

The organisational roles and responsibilities for the activities including maintenance of documentation, quality control and review, and for ensuring corrective and preventive action should be assigned and recorded. Each organisation should ensure that staff members are specifically trained in signal management activities in accordance with their roles and responsibilities (see GVP Module I).

Marketing authorisation holders should include the description of the signal management process in the pharmacovigilance system master file (see GVP Module II). The performance of the system should be controlled and, when used, performance indicators should be presented in the annex to the pharmacovigilance system master file [IR Art 3, 9(1)] (see GVP Module II). Marketing authorisation holders shall put in place a record management system for all documents used for pharmacovigilance activities that ensures the retrievability of those documents as well as the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process [IR Art 12(1)]. As for any critical process, signal management activities should be audited at regular intervals, including tasks performed by any service providers and contractors (see GVP Module IV). Data and document confidentiality (per the applicable laws and regulations), security and validity (including data integrity when transferred between organisations) should be guaranteed.

Documentation demonstrating compliance with these requirements should be available at any time, including justification / evidence for the steps taken and decisions made.