One platform for QC, QA, and quality

QC laboratories and QA and batch release teams use Title21 to plan, schedule, and track every test, review, and quality event, so release decisions are made on time and on complete data.

Every test scheduled automatically

Analysts and instruments are assigned by qualification, priority, and due date, replacing spreadsheets and manual LIMS assignment.

Batch release, tracked and prioritized

A real-time QA whiteboard and release KPIs show what each reviewer is working on and what is waiting.

Quality events traced to closure

Deviations, CAPAs, and change controls follow defined workflows, with trends visible before they become findings.
Release queue, today
QC testing and QA review, all sites
Live
  • Lot 24-0412Finished goodsQA review
    Batch record in QA review, turnaround on target
  • Lot 24-0388StabilityData review
    HPLC results in second-analyst review
  • Lot 24-0405Finished goodsReleased
    Released, right first time
  • Lot 24-0391Raw materialQC testing
    Assay scheduled, HPLC-14 reserved
96%Tests on schedule
18Batch records in review
3Open deviations
Every lot tracked from first test to release

Illustrative example

Solutions for QC and QA teams

For QC laboratories and QA and batch release teams. Start where release is slowest, then add the rest on the same platform.

Smart-QC

Schedule every test

Automatic scheduling of analysts and instruments, capacity planning against your production forecast, and Cost of Quality for every test.

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Smart-QA

Clear the batch release backlog

Batch record release tracking with turnaround and right-first-time KPIs, automated scheduling of QA work, a real-time QA whiteboard, and shift handoffs.

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Smart-QMS

Control every quality event

Document control, training, deviations and CAPA, change control, and audits on one quality system shared across every site.

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Insights

See quality trends early

Ready-made dashboards for CAPAs, deviations, documents, and training, with forecasts that surface problems before an inspector does.

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One record from test to release

QC, QA, and quality work from the same view of every lot, so release decisions are made on complete data instead of chased across systems.

  1. Plan capacity

    Forecast testing demand from ERP and SAP and plan analysts and instruments for the weeks ahead.

    Smart-QC

  2. Schedule and test

    Tests are assigned automatically by qualification, priority, and due date, and rebalanced when plans change.

    Smart-QC

  3. Review batch records

    Every batch record is tracked against turnaround and right-first-time targets, with clear priorities for reviewers.

    Smart-QA

  4. Resolve quality events

    Deviations, CAPAs, and change controls follow defined workflows to closure.

    Smart-QMS

  5. Release and improve

    Batches are released on complete data, and trends show where delays and errors build up.

    Smart-QAInsights

We selected Smart-QC after reviewing 17 different internal/external solutions and have implemented Smart-QC in less than 5 months in 5 of our key sites.

Johnson & Johnson
Smart-QC customer

29%

Fewer batch record errors with Smart-QA

19%

Faster response to correct manufacturing errors

9 of 15

Of the largest companies in the industry use Smart-QC

Smart-QA results reported by Par Pharmaceutical three months after implementation. Smart-QC figure from cResults.

ERP and SAPProduction plans and expected lots
LIMSSamples, tests, and results
Title21One view of every test, review, and quality event
Training and equipmentLMS and CMMS systems
QMSTrackWise and quality events
Integration health 4 connected0 errors0 in queue

Illustrative example

Built around the systems you already run

Title21 takes demand from ERP and SAP, samples from LIMS, and events from your quality systems. Feeds into Smart-QC and Smart-QA are one way from your GxP systems, so they don’t need validation.

Built for

21 CFR Part 11EU GMP Annex 11GMPALCOA+

Business Case

A business case built for your QC and QA teams

Tell us about your company and we’ll send you a personalized business case tailored to your QC and QA operations. It shows what manual scheduling, review backlogs, and late releases cost your teams today, and how a connected platform pays back.

Tell us about your company.

See your release process on one platform.

Bring next week’s QC schedule or your batch record backlog.
We will walk through it with you on Title21.

Schedule a demo
Contact sales