Pharmaceutical quality control
Release every batch on a calibration you can defend.
Related substances, nitrosamines, residual solvents, extractables and leachables. Every reportable result traces back to a calibration. WLTR shows every candidate model side by side and objectively identifies the best fit, so QC can release, investigate or reject on numbers it can stand behind.
Why labs switch to WLTR
Review every impurity calibration at once, not one peak at a time.
Chromatography data systems were built to acquire and process data, not to judge a calibration. WLTR does that job objectively, for every analyte, in one view.
- Your CDS shows one analyte at a time, on one small screen.
- Curves are checked by hand, analyte by analyte, often in a spreadsheet.
- The model is chosen by whoever processed the batch, often a junior analyst.
- QA directors sign off without an objective basis for the curve that was chosen.
- Every analyte and every candidate model on one screen, in the Calibration Intelligence dashboard, with multi-analyte visibility.
- Every curve is checked automatically, including accuracy at the reporting threshold.
- The best fit is determined objectively: same data, same answer, every time.
- QA directors review exceptions only, with one unified calculation behind every calibration.
Hours back every batch
Review by exception instead of one analyte at a time.
Peace of mind for QA
An objective, documented basis for every curve that is signed off.
Accurate data for release decisions
Results built on the best-fit calibration, not on habit.
More capacity, more revenue
Faster review frees analysts and QA to take on more work.
What WLTR adds to your data
A passing calibration is not the same as the right calibration.
Impurity and trace methods are accepted on system suitability and a correlation coefficient, rarely on how accurately each level recalculates. WLTR independently evaluates your calibration standards, ranks how well each established model fits, and documents the result for every analyte on every instrument.
The right fit, backed by evidence
WLTR evaluates the candidate calibration models side by side, so the option your lab reports for each analyte is supported by data rather than habit or software defaults.
Accuracy where release decisions are made
Impurity results are judged against reporting, identification and qualification thresholds, and nitrosamines against acceptable intake limits. WLTR checks every calibration level, including low-end accuracy, so bias near a limit surfaces before a batch is released or an investigation is opened.
Every impurity, every instrument
Nitrosamine, residual solvent and impurity methods quantitate many analytes per run. See which compounds and instruments struggle, and trend them over time. Multi-analyte oversight
Records that stand up to review
A documented, reproducible calibration evaluation supports FDA inspections, laboratory investigations and customer audits. Audit defensibility
See it for yourself
Same calibration. Three models. Three different answers.
Switch the calibration model and watch how accurately each standard recalculates. The unweighted linear fit posts an r² above 0.998 and still misses badly at the low end, right where quantitation limits and reporting thresholds live.
How to read this: each dot is one calibration standard. The closer to the center line, the more accurately that standard is recovered. Pick a regression model:
Recalculated accuracy of each calibration standard. Shaded band shows an example ±20% acceptance window; your method and SOP set the actual criteria. Illustrative data.
Inside WLTR
From ICAL export to a defensible record.
Step 01
Upload the calibration straight from your data system.
Drop in the calibration export from your HPLC, LC-MS/MS or GC data system, including Empower. WLTR parses the run and confirms instrument and method context. Nothing about how your instruments acquire or process data changes.
Step 02
Impurity lists, mapped once.
Impurity and analyte names rarely match across instruments, software and methods. WLTR maps every analyte to a consistent name so results can be trended across runs, products and instruments.
Step 03
Every compound, every model, side by side.
WLTR fits each analyte against the candidate calibration models and shows how accurately every standard recalculates, so curvature and low-end bias are visible at a glance.
Step 04
A ranked, documented recommendation.
All 19 acceptance criteria roll up into a ranked model comparison with a clear recommendation and the evidence behind it, ready for data review and your data package.
Your CDS remains the system of record. WLTR is the system of verification. WLTR complements your accredited methods. It does not replace your CDS, your LIMS, or your method SOPs. The WLTR methodology is patented (US 12,038,448 B2).
Where calibration risk hides
The calibration problems pharmaceutical QC labs live with.
Accepted on a pass or fail
System suitability and a correlation coefficient decide whether a calibration is accepted, not how accurately each level recalculates.
Matrix effects across products
Formulations differ. A calibration that holds for one drug product can bias trace results in another.
Low standards near thresholds
When the lowest standard fails to recalculate, impurity and nitrosamine results near a limit are in question.
Quadratic fits used to rescue a curve
Switching to a quadratic can make a calibration pass while masking detector saturation or a failing standard.
Investigations and delayed release
An out of specification or atypical result opens an investigation, and batch release waits on it.
Inspection findings
FDA warning letters regularly cite laboratory controls and data integrity. The calibration behind a reportable result needs to hold up.
How it works
Three steps. No change to your methods.
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Export
Export calibration data from your chromatography data system.
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Evaluate
WLTR fits your standards against the candidate calibration models, scores each one, and ranks model performance for each analyte.
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Review and document
Analysts, data reviewers, and QA receive a clear verification result per analyte and instrument, ready for data review, batch records, and inspections.
Regulatory alignment
Built around the standards your lab is assessed against.
| Framework | What it covers | How WLTR supports it |
|---|---|---|
| 21 CFR 211.160 and 211.194 | Laboratory controls and laboratory records for drug manufacturers, including instrument calibration and complete records of every test. | Documented, reproducible calibration evidence attached to every reviewed run. |
| 21 CFR Part 11 | Requirements for electronic records and electronic signatures. | SHA-256 fingerprinted source files, an attributable audit trail and e-signed review of every calibration evaluation. |
| ICH Q2(R2) | Validation of analytical procedures, including the response (calibration) model, range and accuracy. | Model comparison, recalculated accuracy and residual checks across the calibration range. |
| USP <1225> and <1220> | Validation and lifecycle management of compendial and in-house analytical procedures. | Evidence that the calibration model stays fit for purpose across the procedure lifecycle. |
Who it is for
Built for the people who sign the report.
- QC laboratory directors
- QA and QC managers
- Analytical chemists
- HPLC, LC-MS/MS and GC analysts
- Data reviewers
- Validation scientists
Questions
Frequently asked questions
Does WLTR replace our CDS or LIMS?
No. Your chromatography data system remains the system of record and your LIMS continues to manage samples and reporting. WLTR is a verification layer that evaluates the calibration data your instruments already produce.
Does WLTR support 21 CFR 211 and Part 11 expectations?
WLTR gives your lab a documented, reproducible evaluation of each calibration, including how the model you report compares with alternatives and how accurately each standard recalculates. Source files are fingerprinted and every review step is attributable. How WLTR records are referenced in your quality system is decided by your quality unit.
Which methods does WLTR work with?
Methods that quantitate against a multi-point calibration curve, including related substances by HPLC, nitrosamine and other mutagenic impurity testing by LC-MS/MS and GC-MS, residual solvents by GC, extractables and leachables, and cleaning verification.
Do we have to change our methods or SOPs?
WLTR works from calibration data you export after a run. It does not change how your instruments acquire or process data. How WLTR results are referenced in your SOPs is decided by your quality system.
How do we get started?
Apply to the WLTR Pilot Program or request a demo. We will review your workflow and show how WLTR evaluates calibrations from your own instruments.
Pilot program
See what WLTR finds in your QC calibrations.
Bring a recent calibration. We will show you how each analyte’s reported calibration compares with the best-fit model.
References: ICH quality guidelines · 21 CFR Part 211 · WLTR Standards Hub