The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and ...

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

"Risk should be the compass, not the paperwork," said Sindhuri Korrapati, a senior software quality supervisor. It's a striking statement in a field long defined by binders, screenshots, and scripted ...

The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical device production. FDA said the draft ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

The US Food and Drug Administration’s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...