The Food and Drug Administration (FDA) provides guidance for the pharmacovigilance industry. FDA inspections are generally on a two year audit schedule.
What are some of the areas that the FDA looks at when they pay us a visit?
- Do we have an organizational structure to support our activities?
- Do we have quality system procedures (SOPs) in place?
- Do we perform management reviews to ensure that all levels of management are engaged in the quality requirements of the organization?
- Do we have an internal audit program in place?
- Do we have a Corrective and Preventive Action program in place?
The answer to the above questions is yes we do!
We have these programs in place to ensure that we are compliant with all the FDA regulations and guidance that apply to pharmacovigilance. This ensures that we are able to help our clients develop their documentation in alignment with the requirements governed by the FDA for surveillance, the handling of medical information, complaints and reporting Adverse Events.
For more on how we can make compliance simple for you as well, contact us.