The batch that waited three weeks.

Manufacturing finished Tuesday. The batch sat in quarantine while release testing took eleven days. Then an OOS result required investigation—another seven days. Three weeks for a batch that should have shipped in one. The science took two days. The paperwork took nineteen.

QC labs are bottlenecks because they're running modern analytical chemistry on 1990s information systems. Results get transcribed from instruments to notebooks to spreadsheets to LIMS—four copies of the same number, four chances for error. Specifications live in binders that nobody quite trusts. OOS investigations require data assembly from five different sources before analysis can even begin.

From sample to release

Every sample follows the same path: receive, test, check, review, release. The difference is how much friction exists at each transition.

When a sample arrives in Seal, specifications are already assigned based on the material and product. Testing queues based on manufacturing priority, so urgent batches move first. Results check against specs automatically the moment they enter the system. Reviewers see everything in one view—no compiling, no chasing. When release is approved, disposition flows downstream to MES and inventory without anyone copying data.

Specifications and automatic checking

"What's the potency spec for this product?" Should be a one-second answer. Instead it's a fifteen-minute hunt through registration files, validation protocols, master batch records, and last year's email from Regulatory Affairs when the limits changed.

Seal maintains specifications as structured data with version history. Potency for Product X at release: 95.0% to 105.0%. When specifications change, the system tracks which version applied to which batch—complete traceability without document archaeology. And the moment a result enters the system, it's checked automatically. The analyst finishes an HPLC run, potency comes back 94.2%, and below 95.0% means OOS—flagged instantly. The analyst can't miss it, the reviewer can't approve it. The system enforces what policy requires.

OOS investigation with context

An out-of-specification result triggers investigation. In most organizations, someone opens a blank form and spends hours gathering context: What instrument was used? What's its calibration status? What standards were run? What other samples were in the sequence? Was the analyst qualified?

Seal opens investigations with all that context already populated—sample, method, result, instrument calibration, standards used, analyst training. All linked. The investigator can start analyzing immediately instead of assembling documentation. Two-week investigations become two-day investigations, not by cutting corners but by eliminating the data-gathering phase entirely.

Direct instrument integration

The traditional path runs through four transcriptions: HPLC generates data, analyst prints, transcribes to notebook, enters into spreadsheet, copies to LIMS. Four opportunities for error. No audit trail connecting the final number to its source.

The Seal path is direct: instrument generates data, data flows to LIMS. Zero transcription. Complete audit trail. The number in the batch record is the number from the instrument. Direct integrations exist for Agilent, Waters, Thermo Fisher, and other major vendors. For instruments without native integration, standard data formats and custom parsers achieve the same goal.

This isn't a research LIMS—it's built for executing validated methods and releasing batches. Method development belongs in the ELN, where scientists iterate freely. By the time a method reaches QC, it's validated: parameters fixed, acceptance criteria defined, procedure locked. When an analyst runs a release test, they execute a validated procedure with enforced parameters. The system doesn't allow deviation.

Beyond release testing

Raw materials arrive faster than QC can test them. Seal manages incoming inspection as a workflow rather than a pile—materials queue based on manufacturing need, supplier CoA data compares against your results, and disposition flows to inventory the moment testing completes.

Environmental monitoring works the same way. A single elevated viable count might be noise. Three over two weeks is a pattern. Most EM programs catch excursions—they tell you the limit was exceeded. Seal catches drift—it shows you the counts are increasing even while still within limits, so you can address problems before they become excursions, before they become investigations, before they become batch holds.

One platform

QC doesn't exist in isolation. Batches come from manufacturing, results affect disposition, and failures trigger quality events. Because Seal LIMS lives on the same platform as MES and QMS, these connections are native rather than integrated.

When a batch fails testing, MES batch status updates automatically. When an OOS triggers investigation, the deviation opens in QMS with full context attached. Certificate of Analysis generation works the same way: all data already lives in the system, so CoAs generate with one click.

When all tests pass, the batch should release immediately. Seal presents batch status in real time—all tests complete, within specification, instrument qualifications current, analyst training verified. Everything visible in one view. One review. One approval. Ship.

Building specifications manually from regulatory documents takes weeks. Drop the document instead and AI extracts specifications into a structured changeset—test names, acceptance criteria, method parameters. Review what was extracted, edit if needed, approve. The same approach works for supplier CoAs, method parameters from validation reports, specification comparison when limits change.