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FDA s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation | King & Spalding

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document.

International society for pharmaceutical engineeringDrug administration staffComputer software assurance for productionQuality system softwarePrinciples of software validationAssociation for the advancement of medical instrumentationRadiological healthSoftware assurance activitiesBiologics evaluationSoftware assuranceQuality systemCurrent good manufacturing practicesVeterinary medicineInternational societyPharmaceutical engineeringRisk based approach

FDA Issues Medical Device Production Computer Software Guidance

The FDA has issued draft guidance on computer software assurance for computers and automated data processing systems used in medical device production.

Quality system software of the validationComputer software assurance for productionQuality system softwarePrinciples of software validationComputer software assuranceGeneral principlesSoftware validationAutomated process equipment

FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations

Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including.

United statesJohn giantsidisClark universityCyberacta incGeorge washington universityFlorida bar committee on technologyPrinciples of software validationUniversity of new hampshireRationale forTrial populationGeneral purpose computing platformGeneral principlesApplying human factorsUsability engineeringMedical devicesElectronic records

FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations

Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including.

United statesJohn giantsidisClark universityCyberacta incGeorge washington universityFlorida bar committee on technologyPrinciples of software validationUniversity of new hampshireRationale forTrial populationGeneral purpose computing platformGeneral principlesApplying human factorsUsability engineeringMedical devicesElectronic records

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