Your instruments write the record.

HPLCs, balances, mass specs, readers, pH meters. Results land in the executing step as the run finishes. Specs check at capture. Approved methods travel back to the instrument. Nothing is retyped in between.

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Source

files, FTP, APIs

Record

executing step

Proof

checksum, audit trail

batch record · BR-2024-0847executing

7.2Weigh buffer componentsBAL-01 · cleanroom B

target47.5 g ± 0.5

captured—

sync—

7.3Assay · product contentHPLC-02

method—

run—

result—

attached—

capture live

Data lands where the work runs.

Middleware moves files around and leaves the integration to you. Seal records the result in the step that requested it. The spec check fires as the value lands. If it fails, the investigation opens with batch, instrument, and operator already attached.

The middleware pathinstrumentvendor PCexportdata lakeintegration projectyour LIMS, eventuallyfive hops · each one yours to maintain

The Seal pathinstrumentthe executing stepchecked at capture · sealed

deviation · DEV-0218opened 14:32:07

opened byspec check at capture · PH-04 reading 7.9 · spec 6.8–7.2

attachedbatch BR-2024-0847 · instrument · calibration · operator · sequence

the investigator starts with context, not assembly

Storage, search, and retention: the SDMS blueprint

What connected means.

01Captures every output

Chromatograms from Agilent, Waters, Shimadzu, and Thermo. Spectra from Sciex and Bruker. Plate readers, balances, pH meters, particle counters. If it writes a file, drops to FTP, or speaks an API, it connects.

02Watches where instruments write

Seal monitors the locations your instruments already write to: network folders, FTP sites, instrument APIs. New data is captured within seconds of appearing: named to standard, stamped with instrument, method, operator, and timestamp, checksummed, immutable.

03Checks at capture

Acceptance criteria fire the moment the value lands, inside the step where the work is happening. 4.532 stays 4.532: no export step, no USB drive, no transcription window for the number to change in.

04Sends the method back

The approved spec generates the sequence or worklist and pushes it to the instrument. What runs is what QA signed, version and all. When the spec changes under change control, the instrument follows.

05Runs without the network

Gowned-in suites, basement labs, instruments your IT policy keeps off the network. Execution continues offline and syncs when the connection returns: timestamps from capture, audit trail intact.

Capture and dispatch. Not process control.

Seal sends instruments their instructions and records what they measure. Control loops stay in your control systems. Seal knows what the bioreactor did. It never decides what it does next.

FAQ

Any instrument that outputs data to a file system, FTP, or API. HPLCs from Agilent, Waters, and Shimadzu. Mass specs from Thermo, Sciex, and Bruker. Plate readers, dissolution testers, particle analyzers, balances, pH meters. If it creates data files, Seal can capture them.

Seal monitors locations you configure: network folders, FTP sites, instrument APIs. When new data appears it is captured with its metadata (instrument, method, operator, timestamp), named to a standard, and stored with integrity controls applied. No manual export, no USB drives.

Timestamps come from the system clock at capture, not from whenever someone remembers to save. Raw files are immutable: you can reprocess, but the original never changes and the reprocessed result links back. Checksums verify the data on disk matches what the instrument generated, every access is logged, and review and approval carry Part 11 compliant e-signatures.

Execution continues. Values are captured locally with capture-time timestamps and sync when the connection returns, audit trail intact. Gowned-in suites and disconnected floors run the same way by design.

One instrument first. One connected record.

Start with the instrument under the most pressure: the HPLC behind your release assay, the balance behind weigh and dispense. Your first process is live in 48 hours; connect the instrument that feeds it, prove the loop, then expand on the same record. The integration catalog carries the long tail of file drops, FTP, APIs, and the business systems around them.

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