Principles of effective compliance inspection

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Compliance inspection can be defined as the inspection, testing and other activities that are required on a regular basis (at least every 90 days) in accordance with the maintenance program and plan and this Chapter, including the completion of a written or electronic checklist, and must be conducted and certified by a qualified person.[1]

Compliance Inspections are crucial as the purposes are to listen to the concerns of workers and supervisors. gain further understanding of jobs and tasks. identify existing and potential hazards. However, the compliance inspection are required to consist of important principles in order to ensure the effectiveness

Here are five principles Altasciences as follows [2]:

1.   Work with compliance in mind at all times. Ensure that every day, every activity completed on a study is up to the standards required for an inspection. Each piece of data, each element of study design, conduct and reporting is as important as the next, working together like a well-tuned Swiss watch. Inspections often occur without warning. When everyone involved, from senior management to scientists to technical staff, has the same dedication to the quality and integrity of their work, we are always prepared should an inspector arrive on site.

2.   Have a game plan, with a support team at the ready. We have a team of individuals appointed from several departments, trained to support the inspectors by rapidly accessing any requested information. Helping the investigators obtain the information they need quickly and efficiently is in everyone’s best interests.

3.   Be proactive. We always make sure that the investigator has the support necessary to effectively perform their inspection. We seek to understand before being understood, so we can provide the insight and data the investigators need.

4.   Know that you’re on the same team; create an environment of trust. Compliance to regulatory standards is a crucial element of the service being provided to clients, so it’s crucial to be willing and able to demonstrate the integrity and quality of our work and procedures.

5.   Ensure that all staff members are comfortable interacting with inspectors. When the inspectors wish to discuss with staff members not on the support team, we want them to feel at ease. By following the principles above, we can proceed with the knowledge and confidence that we need only present, and sometimes explain, what has been done. There is nothing to defend in the quality or integrity of our work.

We know that this approach is successful, and we are proud that Altasciences has consistently met inspection requirements for data integrity, reconstructability, SOP and protocol compliance.




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