data integrity

Securing data under GxP

Description

In regulated activities such as the pharmaceutical industry, data integrity is fundamental to ensuring that all computerized systems handle data correctly and reliably. This means maintaining and protecting data throughout its lifecycle - from collection to archiving - to guarantee that the information is complete, accurate and accessible to authorized parties.

Complying with GxP regulations requires not only technical expertise but also a deep understanding of the regulatory principles that govern how data is handled and protected. This understanding includes the principles of ALCOA, which stands for Attributable, Legible, Contemporaneous, Original, and Accurate. These principles are central to ensuring data integrity and also include modern extensions such as ALCOA+, which adds additional dimensions such as Complete, Consistent, Enduring, and Available. This includes implementing robust systems and processes that can withstand internal and external challenges to data integrity, which is crucial for both compliance and patient safety.

instructor-led
E-learning
Customised