As discussed in the final guidance, FDA anticipates that the agency and industry will need up to 60 days after the publication of this guidance to operationalize the recommendations discussed; however ...

This committee will establish a system of graphical symbols, charts, matrices, and diagrams that will specify and facilitate implementation of software-based control systems. These documents may ...

SAS no. 103 establishes standards and provides guidance for auditors to follow when documenting their work during audits of private companies. It is effective for audits of financial statements of ...

“Working software over comprehensive documentation” is the second value stated in the Agile Manifesto. The Manifesto’s signatories were fighting against the business and technical requirements ...