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Compliance with Regulations and Standards

QSR, FDA CFR 21 Part 820

Aligned Elements provides you with excellent design control as required by the Quality System Regulations (QSR).

Your DHF is maintained including all your requirements, specifications, tests, and risk artefacts.

End-to-end traceability, integrated version and review control, document management, and audit trail, all these things covered directly in Aligned Elements.