FDA computer software assurance (CSA)
Regulatory guidance / GMP guidelineMedical-device manufacturers assuring software used in production or their quality management system.
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Regulations & Guidance
Find regulations, standards and guidance relevant to software validation, data integrity, quality systems and AI. See where each source applies and how it relates to practical controls, testing and evidence.
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21 CFR Part 11
RegulationElectronic records and signatures within FDA Part 11 scope, tied to the underlying required records.
FDA QMSR / 21 CFR Part 820
RegulationFinished medical-device manufacturers and the operations within Part 820 scope.
EU GMP Annex 11
Regulatory guidance / GMP guidelineComputerised systems supporting activities in the applicable EU pharmaceutical GMP context.
Proposed Annex 11 and Annex 22
Regulatory guidance / GMP guidelineProposed computerised-system and AI controls for pharmaceutical GMP manufacturing.
ISO 13485:2016
StandardOrganizations performing medical-device lifecycle activities or related services.
ISO 14971:2019
StandardRisk management throughout the medical-device lifecycle, including medical-device software.
IEC 62304
StandardDevelopment and maintenance of software that is a medical device or an integral part of one.
ICH Q9(R1)
Regulatory guidance / GMP guidelineQuality risk management across the pharmaceutical product lifecycle.
FDA PCCP for AI-enabled devices
Regulatory guidance / GMP guidelineAI-enabled devices, including applicable device-led combination products, within the 510(k), De Novo or PMA pathways.
NIST AI RMF and Generative AI Profile
Industry guidance / frameworkCross-sector AI governance and risk management, including generative AI.
EMA computerised systems in clinical trials
Regulatory guidance / GMP guidelineSponsors, investigators and service providers using computerised systems and electronic data in clinical trials.
IEC 82304-1:2016
StandardManufacturers of health software placed on the market without dedicated hardware, for general computing platforms.