The exact state of computer software validation (CSV) can be tricky to pin down. While industry insiders can call it slow to change, attempting to sort through various complex procedures, approaches, ...

Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer.

Validating Software as a Medical Device (SaMD) Risk-based validation is critical for ensuring software performs correctly.

For example, the risk and quality team at a device manufacturer may be faced with the validation of two different computer systems: a spreadsheet used to track vendors and their approval status, and ...

The FDA computer system validation is mainly done for spread sheets, production equipment, data migration, user requirement, design specifications, compiling the validation plan, qualification needs, ...

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.

In discussing these hardware and software options, we'll include the best practices for meeting FDA's requirements for validation, 21 CFR Part 11, as applicable, and data integrity.

This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation ...

The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs.