Giving a Boost to the Facility of the Future | Pharmaceutical Technology
Recently Presented in ISPE Conference - FDAAWARE discusses the usage of 483s and other information to assess compliance risks
Analysis of "big data" has many applications in the pharmaceutical industry, one of which is to improve risk assessment of manufacturing facilities. "Unstructured information from FDA— including 483s, inspection details, recalls, warning letters, and the CFR [Code of Federal Regulations]—can be examined to help identify compliance risk and determine what problem areas to address first, to avoid past mistakes, or to audit vendors," explained Rafi Maslaton, president at cResults Consulting, in a presentation at the ISPE event. His company has developed a platform called FDAAWARE, which creates a database of these public data and uses software to analyze and extract useful information, in conjunction with an advanced projection algorithm to assess specific sites and overall company compliance related risks.
FDAAWARE AND MDICONSULTANTS, INC ENTER INTO PARTNERSHIP TO IMPLEMENT FDAAWARE in the Life Science Industry
NJ FDAAWARE and NY MDICONSULTANTS, INC (MDI), January 25, 2016 – cResults, the developer of Smart-QA, Smart-QC, Smart-QD and FDAAWARE, has experienced significant growth in the demand for its software solutions over the past year. FDAAWARE is the ONLY cloud-based risk management platform fully integrated with FDA FOIA gathering compliance intelligence to reduce the likelihood/severity of 483s. FDAAWARE uses a unique algorithm, combined with client-specific inputs, to identify potential risk areas, assist in significantly reducing clients’ compliance risk, and better prepare them for an upcoming inspection...
FDAAWARE DATA SHEET
The first cloud based platform to support companies regulated by the FDA in preventing 483s by leveraging a robust projection algorithm and implementing continuous process improvements...