Join this interactive two-day course to master cost-effective computer system validation. Learn the 10-step risk-based approach to cut compliance costs by two-thirds while meeting Part 11 and ...

The SOP describes in detail how to measure a particular sample using a computerized system. A computerized system is not only the equipment and its related software. It also includes network ...

Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex ...

Any validation plan must detail how this is to be achieved, whether the software and instrument qualification will be separate or as part of the same approach. In thermal analysis, most instruments ...