The FDA recently proposed draft guidance: Computer Software Assurance for Production and Quality System Software. The guidance provides recommendations regarding computer software assurance for computers or automated data processing systems used as part of production or the quality system. Per 21 CFR 820.70(i) Automated processes. When computers or automated data processing systems are used as […]
Month: March 2023
Food and Drug Administration (FDA) Transitions from QSR to QMSR
The Food and Drug Administration (FDA) recently presented a webcast to the industry regarding the proposed FDA Quality Management Systems Requirements (QMSR). The FDA QMSR is intended to replace the current US FDA Quality Systems Requirements (QSR – 21 CFR 820) with the Internationally recognized standard ISO 13485:2016: Medical devices – Quality management systems – Requirements for […]