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 organizations must implement based on the 1) type of products they make and 2) country in which their products are sold. When life sciences organizations use computerized systems to perform certain GxP activities, they must ensure that the computerized GxP system is developed, validated, and operated appropriately for the intended use of the system.
Factbird’s roots are originating from the pharmaceutical industry and we have domain experts which can help you navigate in your specific situation. Reach out to your account manager to set up a meeting with a domain expert.
No. Factbird is working with many pharmaceutical and medical devices customers, as well as AWS to navigate FDA compliance requirements. Factbird do 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.
GxP Compliance - Amazon Web Services (AWS)
Factbird is often used in validated environments to support deviations and to demonstrate process stability through scrap rates.
Factbird logs all create/update/delete events. Audit logs may be requested through Factbird support and is priced per time used per audit request. Audit logs are stored for 3 years as default and is customizable for enterprise customers.
Yes, numerous customers use Factbird for pharmaceutical manufacturing or medical devices. We know Blackbird is often used to support deviations and other GxP procedures. Because of confidentiality agreements, we do not disclose specific companies and their use of Factbird. However GxP use cases that we are allowed to share are available on our reference list here: