The batch is done. Why can't you release it?

Manufacturing finished three days ago. QC results are in. The batch sits in quarantine while QA pieces together the evidence for release. This isn't a QA problem. It's an architecture problem.

QA became the integration layer

Batch release requires bringing together execution data from your MES, test results from LIMS, deviations from QMS, equipment logs from maintenance systems, training records, and documentation from file shares. These systems weren't built to talk to each other. So QA manually bridges them—exporting, cross-referencing, reconciling, compiling.

Industry benchmarks suggest QA teams spend 20–30% of their time reconciling data across systems rather than actually reviewing quality outcomes. Batch review cycles take 20–40% longer when data isn't integrated. The work gets done. Batches eventually release. But the cost is hidden in cycle time, rework, and QA burnout.

What batch review looks like today

A QA reviewer opens the batch record. It shows execution steps completed. But the deviation context is missing—a deviation was raised during the batch, and the QMS has the record, but it doesn't show what was happening in the batch at that moment. The reviewer exports MES data, aligns timestamps, and reconstructs the context manually.

Test results require lookup in a separate system. QC results exist in LIMS, so the reviewer opens another application, finds the batch, confirms results are within spec, and screenshots or copies the data. Equipment qualification needs verification—was the bioreactor qualified? When was it last calibrated? Another system, another search. Training records need confirmation—did the operators have current training? HR system or training database, another lookup.

By the time the reviewer has compiled everything, hours have passed. For complex batches, days.

What batch review should look like

Open the batch. Everything is there. Execution steps with inline test results. Deviations linked to the exact step where they occurred. Equipment status at time of use. Operator training verified automatically. Review by exception, with only items needing attention flagged.

The reviewer focuses on judgment calls, not data assembly.

How Seal enables this

Seal doesn't just store data—it links data. When a batch executes, test results, deviations, equipment, and personnel are connected in real-time, not reconciled after the fact.

A unified batch view shows execution, testing, deviations, and equipment on one screen. No tab-switching, no exports, no manual alignment. When a deviation is raised during a batch, it's automatically linked to the step, the operator, the equipment, and the test results at that moment. Reviewers see full context without reconstruction.

The system reviews by exception, flagging what needs attention: out-of-spec results, open deviations, missing signatures. Everything else is pre-verified. When review is complete, one-click disposition releases or rejects with full audit trail. No compilation step, no handoff to another system.

Every review decision, every approval, every data point is traceable and audit-ready by default. When auditors ask "show me the release decision for Batch 2847," you show them in seconds, not hours.

Concurrent release for accelerated therapies

For products with short shelf lives—cell therapies, radiopharmaceuticals, certain biologics—traditional batch review simply doesn't work. You can't wait three days to release a product with a 48-hour shelf life.

Seal enables concurrent release, where QA reviews data during the batch rather than after completion. As each step executes and each test result arrives, reviewers can assess quality in real time. The Certificate of Analysis builds incrementally. When the final test passes, the release decision can happen within hours of production completion.

This isn't cutting corners. It's eliminating the artificial delay between production and review that exists only because data wasn't accessible during the batch.

The impact

When batch review stops being a compilation exercise, release cycles shorten dramatically. What took days takes hours. What took hours takes minutes. QA focuses on quality—reviewers make judgment calls instead of assembling spreadsheets. Rework decreases because investigations don't reopen due to missing context the first time. And audit prep disappears entirely because the batch record is the audit trail. Nothing to compile.

This isn't about working harder. It's about not doing work that shouldn't exist.