Organizations should adopt a strategic approach for inspection readiness to take their company forward and to refine the necessary skills. Through IR activities, organizations can get through the inspection.
FREMONT, CA: One of the most tedious tasks is health authority inspections because preparing for an examination is never a care-free process. Only proper tools can help the team and programs to navigate the inspection while adopting a strategic and the right approach to the inspection readiness (IR) preparation. Here are some of the strategies that can prepare organizations for review.
1. Schedule properly
Consider the needs of an organization and then carefully plan and execute the IR activities. Utilize plenty of time to prepare for the inspection. However, plan the time for preparation based on the size of your organization, the development stage, and the submission goals. A large company and a small company would be cited as an example. It has to start planning from two to three years in advance, while a smaller company can begin 12 to 18 months before submission.
2. Understand the existing state of inspection readiness
An organization must have an estimation of its IR activities, and it is critical to complete it. The company can attempt to learn and determine the current status of their organization regarding IP. The study team can tell the areas prone to high-risks or the issues. The organization must utilize some time to review audit reports and CAPAs (corrective and preventive actions) to ensure that any identified issues are adequately resolved.
3. Prioritize on activities using the readiness assessment
The data collected during the organizational readiness assessment must drive IR activities. Have a thorough understanding of the things that can add value so that people can stay engaged and immersed during inspection readiness activities. Organizations should be transparent and explain to the teams about the reasons for the performed activities to stay motivated and feel utilized.