Loading…
GCP/GLP compliant sample tracking, double-blind randomization, PK calculations, and automated regulatory dossiers.
Contract Research Organizations and bioanalytical laboratories require strict double-blind randomization, multi-timepoint sample custody tracking, and instant chromatographic assay ingestion. Novaqis LIMS delivers a 21 CFR Part 11 compliant bioanalytical platform with zero per-analyst seat taxes.
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Automate barcode generation and blind sample coding for clinical BA/BE trials, tracking freezer storage (-80°C), thaw cycles, and extraction plates.
Ingest analytical sequences from chromatography and mass-spectrometry workstations via InstrumentLink / IDAS with automated calibration curve fitting (1/x² weighting).
Calculate Cmax, Tmax, AUC0-t, and AUC0-∞ with double-blind verification and generate ready-to-submit regulatory study dossiers in seconds.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
Tracks freeze-thaw cycles, aliquot splits, and storage locations with immutable timestamps.
Automated linear and quadratic regression analysis with automated acceptance criteria checking.
Single-click export of complete bioanalytical study audit packages for US FDA and DCGI audits.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
100% GCP / GLP and 21 CFR Part 11 regulatory compliance
Elimination of manual LC-MS/MS data transcription errors
Multi-sponsor data segregation and secure sponsor portals
Unlimited bioanalytical analysts on enterprise site licensing
FAQ
