One platform for every client, suite, and batch

Contract manufacturers and GMP manufacturing facilities use Title21 to run manufacturing, QC, and quality as one operation. Each client’s processes are kept separate and every record is ready for review.

Client processes, right first time

Versioned masterplans for each client guide every step, catch errors as data is entered, and let QA review by exception.

QC capacity you can commit to

Automatic scheduling and capacity planning show what your lab can deliver, so release dates you promise are dates you can keep.

Ready for every audit

21 CFR Part 11 and EU Annex 11 e-signatures, complete audit trails, and audit management keep you ready for clients and regulators alike.
Production and release, this week
All clients and suites
Live
  • Lot 2241Client AQA review
    Batch record reviewed by exception, 1 comment open
  • Lot 1187Client BQC testing
    Sterility and endotoxin scheduled, analysts assigned
  • Lot 2236Client AReleased
    Released, record package ready for the client
  • Lot 0954Client CManufacturing
    Suite 3, step 9 of 14 in the client masterplan
94%Right first time
31QC tests scheduled today
1Client audit next week
Every lot traced from first step to release

Illustrative example

Solutions for CDMOs and GMP facilities

For contract manufacturers and GMP manufacturing facilities. Start where release is slowest, then add the rest on the same platform as you bring on new clients.

Smart-MES

Run every client’s process

Versioned electronic batch records, environmental monitoring, cleanroom workflows and material and equipment control.

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Smart-QC

Commit to release dates

Automatic scheduling of analysts and instruments. Capacity planning based on your production forecast. Cost of Quality per test and per product to price work accurately.

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Smart-QMS

Pass every client audit

Document control, training, deviations and CAPA, change control, and internal and external audit management are all managed on one quality system across every site.

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Smart-AId

Review records with AI

AI that reads batch records and paper forms, flags what needs attention, and keeps a human reviewer and full audit trail in the loop.

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Insights

Show your quality performance

Live dashboards for CAPAs, deviations, documents, and training, with any view exported for leadership and management review.

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One record from client process to release

Manufacturing, QC, and QA work from the same lot record, so every client gets a complete, consistent record without it being pieced together across systems.

  1. Process setup

    Each client’s process is built once as a versioned masterplan, ready to run in any approved room.

    Smart-MES

  2. Manufacturing

    Operators follow guided batch records, with environmental monitoring and cleanroom work in the same system.

    Smart-MES

  3. QC testing

    Tests are scheduled automatically across analysts and instruments, so QC never holds up a client’s release.

    Smart-QC

  4. Review and release

    Batch records are reviewed by exception with AI assistance, and deviations are traced to closure.

    Smart-AIdSmart-QMS

  5. Audit and review

    Every record is ready for the client’s audit, and quality performance is ready for review.

    Smart-QMSInsights

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

90%

Faster batch release with Smart-MES electronic batch records

81%

Less time spent on batch documentation

9 of 15

Of the largest companies in the industry use Smart-QC

Batch record results are averages from Title21 client internal audits one year after implementation, client-reported. Smart-QC figures from cResults.

ERP and SAPProduction plans and expected lots
LIMSSamples, tests, and results
Title21One record for every lot, test, and quality event
EquipmentAPIs, OPC, and device integration
QMS and trainingTrackWise, LMS, and HR systems
Integration health 4 connected0 errors0 in queue

Illustrative example

Built around the systems you already run

Title21 collects production plans from ERP, samples from LIMS, and data from equipment and instruments. This means every lot record is complete without having to re-enter information. Integrations into Smart-QC only go one way from your GxP systems, so you don’t need to validate them.

Built for

21 CFR Part 11EU GMP Annex 11GMPALCOA+

Business Case

Get a business case built for your facility

Tell us about your company and we’ll send you a personalized business case tailored to your contract manufacturing operations. It shows what batch record errors, late releases, and client audit prep cost your teams today, and how a connected platform pays back across your client portfolio.

Tell us about your company.

See every client’s batch on one platform.

Bring a client’s batch record, next week’s QC schedule, or your next client audit.
We will show you how it runs on Title21.

Schedule a demo
Contact sales