BioProcess International

Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in GxP Environments

Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in ...
technologynetworks

Improving Time-to-Value for GxP Computer Systems

In today's fast-moving world of vaccines, gene therapies and biotherapeutics, computerized systems play a critical role in the discovery, manufacture and delivery of potentially life-saving drugs.
CNBC

FDA's Grace McNally to Speak at ISPE Process Validation Conference

TAMPA, Fla., Oct. 1, 2012 /PRNewswire-USNewswire/ -- ISPE announced today that the FDA's Grace McNally will speak at the ISPE Process Validation Conference, taking place at the Sheraton Silver Spring ...
JD Supra

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
MD&M East

Software Validation: Turning Concepts into Business Benefits

For a variety of reasons, software verification and validation has proven to be one of the more challenging and nebulous areas of compliance for companies regulated by FDA. Software, and how it is ...