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Paper records what happened. Seal checks it as it happens.

Seal, the GxP execution system, is your eBR, your QMS and more. Neil, your AI agent, does the paperwork across your systems. You sign. MiAlgae cut documentation time by 75%. Start with one process beside paper and spreadsheets.

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What Seal’s customers measured.

Each figure links to the customer’s story.

QualityAcclinate and Skye Biologics

−50%
quality cycle times at Acclinate, from a procedure change to everyone trained.Acclinate
−40%
non-conformances at Skye Biologics, with training checked before execution.Skye Biologics

RecordsMiAlgae and Bioventix

−75%
documentation time at MiAlgae, from the lab to commercial production.MiAlgae
−80%
document admin time at Bioventix, after two decades on paper.Bioventix

Where paper and spreadsheets fall short.

From FDA, its warning letters and Seal’s customers.

  • On paper
    At review, after the batch
    In Seal
    At the step

    Mistakes are found after the batch.

    On paper, nothing stops a missed signature or a value out of limits; a reviewer finds it once the work is done. In Seal, the check runs at the step.

  • Paper travelers
    3 to 4 hours a day
    With Seal
    −90%

    Review takes hours.

    At Paradromics, senior engineers spent a combined 3 to 4 hours every day reviewing paper travelers. With Seal, that time fell by 90%.

    Paradromics
  • FDA’s investigator
    An incorrect formula
    The firm’s review
    Another error

    A spreadsheet is a program you have to validate.

    FDA’s investigator found an incorrect formula in one firm’s assay spreadsheet, and the firm’s own review then found another error.

    FDA warning letter, December 2019
  • Blank forms
    Controlled, numbered
    Once complete
    Reconciled
    Spoiled
    Kept, with a reason

    The forms need controlling too.

    FDA expects blank forms to be controlled, numbered sets reconciled once complete, and spoiled forms kept with a reason. In Seal, each record opens from the approved version.

    FDA data integrity guidance, 2018
  • On paper
    Over 20 years
    Storage
    Running out
    Admin, with Seal
    −80%

    The history is in boxes.

    Bioventix ran its quality system on paper for over two decades, was running out of storage, and searched binders for historical data.

    Bioventix

See it in Seal.

Real Seal screens with fictional test data: one late transfer, from the batch record to the fix, Neil’s overnight release review, and an old paper record, read.

  1. 1

    Each value at the step it belongs to.

    Batch B-041’s readings are recorded as the work happens, with its sample and its deviation linked to the record.

    Batch record B-041, post-mix hold and transfer, in Seal: the instruction to transfer within 45 minutes of completing the mix, process readings at 10:12, 10:42 and 11:04 with temperature and pH, and the linked lab sample IPC-041 and investigation DEV-018.
    1. The step’s limitTransfer within 45 minutes of completing the mix.
    2. Recorded as it happensMix complete at 10:12, transfer at 11:04: 52 minutes.
    3. The deviation, linkedDEV-018 sits on the batch record it concerns.
  2. 2

    The fix is a change to the workflow.

    CC-019 makes the record calculate the hold and route anything over 45 minutes. It is verified before release, and the next batch runs the new version.

    Change CC-019, elapsed-time check, in Seal: DEV-018 as the reason, the affected procedure MBR-014, a table of current and proposed workflow behaviour, a verification plan at 44, 45 and 46 minutes and a missing start time, and a release review for authorised people.
    1. From the deviationDEV-018 is the reason for the change.
    2. The workflow itselfThe hold is calculated from both timestamps, and anything over the limit is routed for assessment.
    3. Verified before releaseAt 44, 45 and 46 minutes, and with a start time missing.
  3. 3

    Neil checks every lot. People decide.

    Overnight, Neil checked each lot against its release plan and said what its record leaves out.

    The release board in Seal: 111 lots in release across three sites, $123M waiting, 86 with nothing open, and a table of the lots with findings, each with Neil’s summary, its value and a predicted certification date.
    1. The morning, in two lines111 lots and $123M waiting. 86 need only a decision.
    2. Neil’s summary of each lotWhat is open, and where Neil found it.
    3. A predicted certification dateFrom how long this site’s lots have taken.
  4. 4

    Neil reads your old binders.

    Scanned batch records become values, each linked to its place on the page. What it can’t read for certain goes to a person.

    Seal showing check C-33, GDP corrections: a struck-through sucrose weight on page 23 read from the handwriting, with no correction initials, date or reason, and the scanned page open with the row outlined.
    1. A correction, read and judgedA struck-through weight on page 23, with no initials, date or reason beside it.
    2. The entry, from the handwriting8.251 struck through, 8.215 kg written beside it, initialled BdJ on 28-Sep-26.
    3. The row on the scanOutlined on page 23 of 212.

Paper, spreadsheets and Seal, side by side.

Every source is listed under References.

Paper and spreadsheetsSeal
What it isBinders, Word forms, Excel and shared drivesThe GxP execution system: your eBR, your QMS and more
Data modelA page, a cell or a filePrimitives your team composes: record types, their relationships, steps and checks
A missed step or a value out of limitsFound at review, after the work is doneChecked at the step, as the work happens
ValuesWritten by hand, then typed againRecorded as the work happens, from balances and instruments where connected
PaperworkWritten and assembled by peopleNeil, your AI agent, drafts it; you sign
Blank formsIssued, numbered and reconciled¹Each record opens from the approved version
CalculationsExcel formulas you validate and protect²Configured, with selected tests on each change prepared for review
TrainingA matrix someone keeps up to dateChecked at the step that needs it
Past lotsPulled from bindersSearched and trended; Neil reads old binders
Getting startedNothing to buy, and everything to keep by handA 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
Paper and spreadsheets are good for a small process that rarely changes. Regulators accept them: FDA’s data integrity guidance names a paper record as a fixed-data record,¹ and Bioventix ran its quality system on paper for over two decades. But every check comes after the work. FDA expects blank forms to be controlled, with numbered sets issued and reconciled; it notes that a spreadsheet may let its user change formulas or entries,¹ and it has warned a firm that relied on unvalidated, unsecured Excel spreadsheets to determine the reportable result for batch release.² PIC/S, the Pharmaceutical Inspection Co-operation Scheme, says the use of hybrid systems, electronic data supplemented by paper records, is discouraged and that they should be replaced whenever possible.³ If your process will not change and your team will not grow, it can work well. That is rare: MiAlgae’s paper systems worked at bench scale and began to strain as production volumes grew.

1Seal is your eBR, your QMS and your LIMS.

They are one set of records, so a result, a deviation and the batch they concern are linked from the start, not copied between files.

2Neil does the paperwork. You sign.

Neil, your AI agent, reads your runs and records, then drafts the comparison, the gap assessment or the review, so you start from a draft, not a blank page.

It reads the old paper too. Scanned batch records, logbooks and forms become values, each linked to its place on the scan. What it can’t read for certain goes to a person, and your team verifies what it read. People decide, and Neil is not used in GMP execution.

3Start with one process.

  1. Choose the process that hurts most: one batch record, one deviation form or one procedure family.
  2. Bring the procedure and a few completed records. Start with sample material, or arrange an NDA first.
  3. Neil drafts the workflow and your team checks it against how the work runs. Once the scope is agreed and the inputs received, Seal prepares the first working process and its validation pack to evaluate within 48 hours. Production timing then depends on scope, interfaces, migration and your release requirements.
  4. Keep paper running for everything else, and agree which system holds which record while the move is under way.
  5. When you want the history, start with one binder: compare what Neil reads with your team’s own transcription of its hardest pages.

References

  1. 1Data Integrity and Compliance With Drug CGMP: Questions and Answers, Guidance for Industry, FDA, December 2018. https://www.fda.gov/media/119267/download (read 5 November 2026)
  2. 2Warning Letter 320-20-10, Tismor Health and Wellness Pty Limited, FDA, 5 December 2019. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tismor-health-and-wellness-pty-limited-588104-12052019 (read 5 November 2026)
  3. 3PI 041-1, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, PIC/S, 1 July 2021. https://picscheme.org/docview/4234 (read 5 November 2026)

AQuestions and answers

Is Seal better than paper and spreadsheets?

Yes. Paper and spreadsheets are good for a small process that rarely changes. Regulators accept them: FDA’s data integrity guidance names a paper record as a fixed-data record, and Bioventix ran its quality system on paper for over two decades. But every check comes after the work. FDA expects blank forms to be controlled, with numbered sets issued and reconciled; it notes that a spreadsheet may let its user change formulas or entries, and it has warned a firm that relied on unvalidated, unsecured Excel spreadsheets to determine the reportable result for batch release. PIC/S, the Pharmaceutical Inspection Co-operation Scheme, says the use of hybrid systems, electronic data supplemented by paper records, is discouraged and that they should be replaced whenever possible. If your process will not change and your team will not grow, it can work well. That is rare: MiAlgae’s paper systems worked at bench scale and began to strain as production volumes grew. Seal has no fixed model of one kind of work. It is built from primitives: record types, the relationships between them, and the steps and checks that use them, which your own team composes into your process, with Neil able to prepare each change for approval. So one platform runs process development, the laboratory, manufacturing, batch release and the quality system, and each change becomes a new version, released once its selected tests pass, while earlier runs keep theirs. Moving from paper, MiAlgae cut documentation time by 75% and went from the laboratory to commercial production on one platform.

Do regulators require us to move off paper?

No. Paper is an accepted record format, and FDA’s guidance describes how to control it. The reason to move is what paper costs: mistakes found after the work, forms to issue and reconcile, and history in boxes. PIC/S does discourage hybrid systems of electronic data and paper records, and says they should be replaced whenever possible.

We’ve validated our spreadsheets. Why change?

Validation makes a calculation reliable. The spreadsheet still sits beside the work: it can’t stop a step, check training, or open a deviation from the record where it occurred. In Seal, the calculation is part of the step, and its result stays with the batch.

Are we too small for this?

Seal starts with one process, and your own team configures it. Bioventix, a company of 11 to 50 people, moved its quality system and lab records onto Seal and cut document admin time by 80%.

Will we have to validate it?

Yes, for your intended use. Seal prepares a validation pack with the first working process, your team approves the intended use, and selected tests run on each change prepared for review. Release needs them passing.

What happens to our paper records?

They stay the record you hold, under your retention procedure. If you want them as data, Neil reads the scans into values, each linked to its place on the page, and your team verifies what it read.

Can operators use it on the floor?

Seal is browser-based. Try the proposed devices, scanners, gloves and network conditions with the operators who will use them. Where offline operation is needed, agree the supported scope and verify it first.

What happens if the system goes down?

Work continues only through an approved and tested business-continuity procedure, which defines safe hold points, critical work and contingency records.

How long does it take to start?

Once the scope is agreed and the inputs received, Seal prepares a first working process and its validation pack to evaluate within 48 hours, configured from one of your procedures. Production timing then depends on scope, interfaces, migration and your release requirements.

Start beside paper and spreadsheets.

Start with one process. Paper keeps running for everything else, so nothing has to move on day one, and when you want the history, Neil reads your old binders into data.

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