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Oasis-AMV (Analytical Method Validation)

Protocol design, automated statistics & 21 CFR Part 11 audit trail — all in one workspace.

Validate With Confidence, Comply Without Compromise

Method Validation Fully Connected to Your LIMS

Oasis-AMV
Oasis-AMV validation workspace — protocol design, automated statistics and audit trail
Analytical method validation is where data integrity is won or lost — spreadsheets scattered across analysts' desktops, validation protocols disconnected from raw instrument data, and manual recalculation of accuracy, precision, and linearity creating fresh opportunities for transcription error. Oasis-AMV closes the gap between validation activity and validation evidence: a dedicated, configurable workspace that manages the full method validation lifecycle — protocol, execution, statistical evaluation, and reporting — with built-in data integrity controls and a complete, tamper-evident audit trail for ICH Q2(R1), USP <1225>, and 21 CFR Part 11.
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Key Features

Protocol-Driven Validation Design

Version-controlled protocols mapped to accuracy, precision, specificity, linearity, robustness & more, linked to the method record from day one.

Automated Statistical Evaluation

%RSD, recovery & correlation coefficients computed instantly as results are entered — no offline spreadsheets.

Real-Time Acceptance Criteria Checks

OOS/OOT results flagged the moment they occur, triggering deviation & CAPA workflows instead of waiting for final review.

Full 21 CFR Part 11 Audit Trail

Every entry, edit, recalculation & approval timestamped, attributed & e-signed — no paper, no gaps.

Instrument & Raw Data Integration

Results pulled directly from connected instruments and analytical software, eliminating manual transcription.

Dynamic Validation Reports

Audit-ready summary reports generated on demand, structured and traceable back to every raw data point.

Revalidation & Method Transfer Tracking

Revalidation studies and method transfer records linked to the original validation, preserving full method history.

Why Oasis-AMV

Single Connected Workspace

Replaces validation data scattered across disconnected spreadsheets with one system of record.

Automated, Error-Free Computation

No manual statistical calculations — accuracy, precision & linearity computed instantly.

Real-Time Audit Trail

Generated live as work happens, not reconstructed after the fact for an inspection.

Instant OOS / OOT Detection

Deviations flagged the moment they occur, not discovered at end-of-study review.