I.B.8. Facilities and equipment for pharmacovigilance

Achieving the required quality for the conduct of pharmacovigilance processes and their outcomes is also intrinsically linked with appropriate facilities and equipment used to support the processes. Facilities and equipment should include office space, information technology (IT) systems and (electronic) storage space. They should be located, designed, constructed, adapted and maintained to suit their intended purpose in line with the quality objectives for pharmacovigilance (see I.B.4.) and also be available for business continuity (see I.B.11.3.). Facilities and equipment which are critical for the conduct of pharmacovigilance (see I.B.11.3.) should be subject to appropriate checks, qualification and/or validation activities to prove their suitability for the intended purpose. There should be processes in place to keep awareness of the valid terminologies (see Module VI) in their valid versions and to keep the IT systems up-to-date accordingly.