Given the growing level of automation, validation of computerized systems must be an integral part of projects to guarantee the quality of products and process controls. This article focuses on the software verifications of two machine models. A...
The new FDA Guidance for Industry on Process Validation states that “activities undertaken to demonstrate utilities and pieces of equipment are suitable for their intended use and perform properly is referred to as...
Today many of us carry in our pockets phones that are vastly more powerful computers than those that took the Apollo astronauts to the moon. These powerful mobile devices have tremendous potential as platforms for...
Calibration is an essential element in ensuring compliance in the pharmaceutical and associated regulated life science industries. To ensure success, calibration should be managed effectively, by appropriately qualified...
This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting...
