Detect calibration failures before BLA review, Form 483, or warning letter exposure.
Biologics enforcement is no longer a tail risk. FDA’s reorganization of the Office of Regulatory Affairs into the Office of Inspections and Investigations, the launch of the Elsa AI system to prioritize inspections, and the explicit shift toward for-cause inspection have moved data integrity and chromatographic record review into the center of every Form 483 and warning letter conversation. The vocabulary regulators now use is specific: data integrity, complete data, audit trail review, validated for intended use, scientifically sound test procedures.
Eliquent Life Sciences analysis of FDA Compliance Dashboard data, March 2026 — a 59% increase from FY24.
Redica Systems analysis of FDA inspection data, February 2026 — approximately 2.5x the prior baseline. For-cause inspections carry a 33.5% probability of an Official Action Indicated classification.
TechSci Research, Global SaaS-Based Chromatography Data Systems Market, September 2021 — projected to grow from USD 270.7M to USD 770.9M.
Recent FDA actions where data integrity, CGMP procedural control, or chromatographic record review were cited.
Action : FDA issued a warning letter to **Berkeley Biologics, LLC** (previously Elutia, Inc.; formerly Aziyo Biologics, Inc.) citing CGMP violations under 21 CFR Parts 210 and 211, including failure to establish written procedures for production and process controls and acceptance of qualification batches that failed established acceptance criteria, including sterility testing.
Outcome : The citation became one of FDA’s most-referenced 2024 examples of CDS-level data integrity failure and is cited in current FDA enforcement training material.
WLTR connects above the CDS layer and beneath the LIMS layer. It reads calibration data from the CDS, re-evaluates the underlying mathematics against the laboratory’s own data set, and writes verification records back into the audit trail. The CDS continues to acquire, integrate, and report. WLTR continues to verify. The two layers are independent by design.
WLTR is built to a strict regulatory boundary. It verifies, evaluates, and documents. It does not modify, replace, or augment any compliance-critical calculation.
WLTR re-evaluates calibration models against the laboratory’s own data. The platform applies deterministic mathematics — not probabilistic inference — to identify calibration curves that meet system suitability on the surface but contain undetected linearity, weighting, or fit error. Results are scoped to the analyte panels and concentration ranges in the validated method, with no method modification.
WLTR verifies CDS-generated calibration outputs against the underlying chromatographic data and against the laboratory’s documented acceptance criteria. The platform serves as the independent verification mechanism that audit-trail review and Tier II QA review require. WLTR does not replace analyst review. WLTR documents that review.
WLTR produces audit-ready records in regulator-aligned language — 21 CFR Part 11, ICH Q2(R2), ICH M10, EU Annex 11. Output formats include calibration model evaluation reports, audit-trail review summaries, and exception documentation suitable for inclusion in batch release packages, BLA supplements, and inspection response binders.
QC Directors, Heads of Analytical Development, and Senior Directors of Quality Operations responsible for instrument fleet planning, CDS platform decisions, and contract laboratory qualification across drug substance and drug product release. WLTR reduces the audit-defensibility cost of operating Empower in QC, Chromeleon in development, and additional CDS platforms at one or more CDMOs.
QA Specialists, QA Managers, and Directors of Quality Assurance who own SOPs governing CDS use, audit-trail review, manual integration controls, calibration acceptance criteria, and OOS investigation. WLTR documents the verification step that 21 CFR 211.194(a) requires and that 21 CFR 211.68(b) audit citations recur on.
