OPPORTUNITY

Good laboratory practice (GLP), good clinical practice (GCP) and good manufacturing practice (GMP), collectively referred to as GxP, are a set of principles intended to ensure the quality and integrity of non-clinical and clinical data collection and study execution as well as manufacturing processes.  It is imperative that records and reports of all raw data, protocols and final reports be retained during the specified time frame by GxP requirements.  Currently, data collection and verification is an archaic and laborious process requiring documents to be printed, signed and then re-curtated and stored electronically. In order for this process to be effective, regulatory bodies, funding agencies and sponsors need to trust that these records have not been tampered with, altered or manipulated in any way throughout the GxP specified time frame. 

BREAKTHROUGH IN GxP RECORD KEEPING AND COMPLIANCE

Inventors at the University of South Alabama are developing a web-application based portal for users to upload data and records related to GxP studies and processes.  Utilizing a distributed ledger platform, this technology ensures that GxP standards are maintained throughout the GxP study.

COMPETITIVE ADVANTAGES

•  Easily upload and track data and progress related to GxP studies

•  Ensure data and information has not been edited or altered

•  Maintain compliance with GxP standards

INTELLECTUAL PROPERTY STATUS

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