New FDA guidance developed to identify lapses in data integrity and promote best practices. With data integrity identified as a primary focus of its enforcement actions, FDA issued a new guidance ...

The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...

A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software. In 2014 through 2016, inspections of pharmaceutical facilities revealed a ...

Pharmaceutical organisations have become increasingly reliant upon automated systems and computers, from manufacturing to laboratory release testing. This has brought a renewed regulatory focus about ...

Human health is a fundamental need of the society. The pharmaceutical industry has played a pivotal role in providing mankind with drugs for preventive and curative care. COVID-19 has further ...

Please give an overview of the recent compliance pressures that have been put on pharmaceutical companies. Compliance always has always been a high priority for data integrity in the pharmaceutical ...

The pharmaceutical world offers a valuable blueprint on how to harness AI’s efficiency while protecting trust, ethics and above all, people.

Who should take this course? This course is designed for laboratory personnel responsible for ensuring and auditing integrity of data in today’s laboratory. It will also be useful for managers and ...