FDA Requirements for ensuring Premarketing Clinical Trial Safety

The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks […]

Supplier audit program

Supplier audit program An internal audit program is needed for any business in which continuous work is needed, such as documentations. An audit ensures that the root cause of documentation is addressed. Documentation that is proper and process-oriented is a regulatory requirement, and hence an audit program is a must. A proper audit program that […]