GxP is an acronym that refers to the regulations and guidelines applicable to life sciences organizations that make food and medical products such as drugs, medical devices, and medical software applications. The overall intent of GxP requirements is to ensure that food and medical products are safe for consumers and to ensure the integrity of data used to make product-related safety decisions.
The term GxP encompasses a broad range of compliance-related activities such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and others, each of which has product-specific requirements that life sciences organisations must implement based on the 1) type of products they make and 2) country in which their products are sold. When life sciences organisations use computerised systems to perform certain GxP activities, they must ensure that the computerised GxP system is developed, validated, and operated appropriately for the intended use of the system.
Factbird’s roots originate from the pharmaceutical industry, and we have domain experts who can help you navigate your specific situation. Reach out to your account manager to set up a meeting with a domain expert.
Does Factbird need to be GxP compliant?
No. Factbird is working with many pharmaceutical and medical device customers, as well as AWS, to navigate FDA compliance requirements. Factbird does not need to be GxP compliant because Factbird is not part of a batch release or quality control. However, Factbird is built on AWS infrastructure and services, which are fully GxP compliant.
Factbird is often used in validated environments to support deviations and to demonstrate process stability through scrap rates.
Is Factbird CFR-21 Part 11 compliant