A healthy dose of guidance for the pharmaceutical industry.
The pharmaceutical and medical device industries are regulated mainly by the Food and Drug Administration. Record requirements are for drugs, animal drugs, medical devices, some over the counter products and more. This template provides those, as well as record series for research and development, product testing, animal testing, clinical trials and regulatory approval. Additionally, the industry requires an enhanced set of requirements for environmental, health and safety and hazardous materials.
While the FDA regulates classes of pharmaceuticals and others mentioned above, they don’t regulate specific products. So besides the general record series, users can add specific laws in areas like controlled substances, animal feed and other drugs. For production, quality assurance, distribution and labeling record series, look to our manufacturing template. Our healthcare module is designed for record series dealing with pharmacies.
Our module offers a default general record series that can be expanded by selecting from dozens of pre-defined records, all linked to retention period and legal research. Specific activities can be chosen and jurisdictions with no pharmaceutical requirements excluded. Finally, all the record series’ subjects, text, and retention can be customized to meet any unique requirements.