QA IT

Quality assurance of computerized systems

Description of the project

In the pharmaceutical industry, where accuracy and reliability are essential, computerized systems play a crucial role throughout the chain from research and development to clinical trials and production. These systems control critical processes in, for example, manufacturing, laboratory analysis and distribution, making their proper functioning essential for the safety and efficiency of the entire production and distribution chain.

Quality assurance of computerized systems and compliance with standards and guidelines such as 21 CFR Part 11, EudraLex Volume 4 Annex 11 and Annex 15, and GAMP5 is therefore fundamental. The focus is on applying standardized processes to validate and verify that the computerized systems meet all prescribed requirements and functions. This includes everything from initial risk assessments to continuous monitoring and updating of the systems to guarantee that they remain in line with both internal quality standards and external regulatory requirements.

Quality assurance of computerized systems is an ongoing process to ensure that all technical solutions not only support compliance but also promote efficiency and reliability throughout the system lifecycle and ultimately provide patients with safe products.

instructor-led
E-learning
Customised