The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
They recommend that the guidelines are followed when clinical trial data will be submitted for consideration by regulatory authorities. Clinical trial monitors must verify that the investigator has suitable qualifications and resources to run a trial. Any equipment and facilities must be adequate so that the trial can be properly and safely conducted, and they must remain adequate for the duration of the trial. Trial investigators must provide documents (e.g. certificates, accreditation documents) for medical, laboratory or technical procedures and tests so that the trial facility can show that it is competent to perform any necessary tests.
Medical Research Council
The Medical Research Council has also published guidelines highlighting the importance of adequately maintaining equipment. They recommend that there should be procedures for ensuring there is training and support for staff that are using, servicing and calibrating the equipment. In cases such as this, working with an equipment partner can help to streamline processes. Medrix Clinical Research (SMO) provides the Medical Equipments calibration services from India’s Leading NABL certified Laboratories.
