Identity, content uniformity and polymorph control across raw materials, in-process and finished dosage forms — signed off under GMP / 21 CFR Part 11.
Replace lengthy wet-chemistry ID with NIR and Raman fingerprinting at the loading dock. QYNARA stores reference libraries, version controls every model, and binds every spectrum to an analyst, instrument and batch — ready for inspection.
Continuous NIR monitoring during blending and granulation gives a real-time picture of homogeneity and water content. Out-of-trend events are flagged, reviewed and electronically signed inside the same workflow.
Through-vial Raman confirms the right polymorph before release. Chemometric models (PLS-R, SIMCA, PCA) are validated, locked and audited — no spreadsheet hand-offs.
21 CFR Part 11 and EU GMP Annex 11 sign-off, audit trail and role-based access are built in — not bolted on.