article thumbnail

How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Here are some ways companies are using AI in clinical trials. The need for new medical treatments and drugs has never been greater.

article thumbnail

What are the elements of quality control process in pharmaceuticals

GMPSOP

. – Record or capture all generated raw data directly, promptly, and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial data entries on the day of entry. – Archive records so that they are protected, secured, and easily retrievable.

article thumbnail

How to perform operational qualification – step by step

GMPSOP

The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products.