Critical Aspects of Quality Management Systems: Focusing on the Validation Process
In regulated industries like pharmaceuticals, medical devices, and food manufac [...]
14
11, 2024
9
10, 2024
The Role of Technology in Supporting ALCOA Principles: Strengthening Data Integrity in Life Sciences with Quality Management Software
In the highly regulated world of life sciences, data integrity is not optional [...]
26
07, 2022
How to Establish Sustainable Validation for FDA & EU Compliance
Software validation is historically one of the most difficult compliance activit [...]
8
03, 2021
Computer Systems Assurance: Making the Transition from Computer Systems Validation
For decades, pharmaceutical and medical device companies have operated under the [...]
1
06, 2020
How Risk-Based Testing is Revolutionizing Computer System Validation
We live in a world where speed is vital to success. Patients and consumers expec [...]
27
08, 2019
Validation of a regulated computer system – what’s the big deal?
Anyone who has been part of a successful validation effort for a regulated compu [...]
