The audit that found nothing wrong.

An FDA auditor points to a deviation from six months ago: "Show me what happened here."

You pull up DEV-2024-047. The screen shows the batch step where it occurred, the equipment status at that moment, the operator's training record, and the investigation trail. The auditor clicks through to the CAPA. It closed three months ago after effectiveness verification—zero recurrence in the following 50 batches, data attached.

The auditor moves on. No finding. No 483. This is what control looks like when you can prove it.

The documentation problem

Deviations in one system. Training records in another. Batch records in a third. To answer "was this operator trained when they executed this step during this deviation," someone assembles evidence from three sources. The answer arrives in hours, if the data exists at all.

This is how minor deviations become 483 observations. Not because of bad intent, but because the system couldn't prove control when asked.

Connected records

A deviation record in Seal contains the batch ID, equipment ID, process values, and operator training status at the time of the event—because those records already exist in the same database. The connection isn't assembled after the fact. It's structural.

When an auditor asks to see a deviation, they see it linked to the specific batch step, equipment calibration status at that moment, and the operator's verified training. Complete chain of evidence, retrieved in seconds.

Document control and training

An SOP is a controlled object, not a file. Operators access only the current effective version. Superseded versions are archived and inaccessible for execution.

When SOP-042 updates from version 2 to version 3, everyone trained on version 2 gets retraining assigned automatically. Until they complete training on version 3, they cannot execute tasks requiring that SOP. Training is a gate, not just a record—the system blocks execution before errors can occur.

21 CFR Part 11 compliance: immutable audit trails, meaning-based e-signatures (Author, Review, Approve), complete version history.

Deviation and CAPA management

Deviations capture in context. The record includes batch ID, equipment ID, and process values at the time of the event—not because someone typed them in, but because that data already exists in the same system.

"Inadequate CAPA" appears on warning letters because organizations close CAPAs on paperwork, not proof. Seal requires effectiveness criteria upfront: "Zero recurrence in the next 100 batches." The CAPA cannot close until verification is complete and evidence is attached. If verification fails, the CAPA reopens automatically.

Integrated quality events

Quality threads connect across systems. An OOS result triggers investigation workflow immediately. Deviations link to batches. Batches link to materials. Materials link to suppliers. When an auditor follows a thread, it never breaks.

Annual Product Quality Reviews compile from live data. The data exists because it was captured during execution. There is no preparation phase—audit readiness is the default state.