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Qualio is built around controlled documents. Seal runs quality, the lab and the batch as you grow.

Seal, the GxP execution system, is your eBR, your QMS and more. Neil, your AI agent, does the paperwork across your systems. You sign. Skye Biologics cut non-⁠conformances by 40%. Start with one process beside Qualio.

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Where Qualio falls short.

From Qualio’s own pages and its reviewers on G2.

  • 2012
    Founded in Ireland
    2015
    SOPs, documents, training
    Batches, equipment
    Registers from other systems

    Built around documents.

    Qualio sold an “all-in-one SOP, document control and training solution” in 2015; today batches and equipment are registers fed from the systems that own them. In Seal, the lab, the batch and quality are one set of records.

    Qualio, November 2015
  • Foundation
    5 event templates
    Growth
    Up to 10
    A new site
    An added instance
    Seal
    Neil, then your approval

    Configuration set by the plan.

    Qualio’s Foundation plan includes five quality event templates and Growth up to ten, and a new site is an added instance. In Seal, Neil configures the first process from your procedure, and your team approves it.

    Qualio, Plans and pricing
  • Qualio, live
    Under 60 days
    Seal, a first process
    48 hours

    Under 60 days to go live.

    Qualio says deployments typically go live in under 60 days. Seal has a first process working for you to evaluate within 48 hours, once the scope is agreed and the inputs received.

    Qualio, Plans and pricing
  • Revised SOP
    Training assigned
    The step
    Runs in another system
    Seal
    The check runs at the step

    Training assigned, checked elsewhere.

    In Qualio, approving a revised SOP assigns the new version to every trainee, and training is tracked to completion; the step itself runs in another system. In Seal, the check runs at the step.

    Qualio, Training Management
  • A G2 reviewer
    “a bit rigid or time-consuming”
    Another
    “limited customization”

    Hard to customise.

    G2’s summary of Qualio’s reviews notes that the integrated editor has “limited formatting and customization options”.

    G2, October 2026

See it in Seal.

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

  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 deviation starts with its evidence.

    DEV-018 has the batch, its readings and the sample linked, so the investigation starts from the facts.

    Deviation DEV-018, extended post-mix hold, in Seal: the affected batch B-041, the transfer 52 minutes after mixing against a permitted 45, and a table of evidence from the process readings, temperature readings and sample IPC-041.
    1. The batchB-041, the batch the deviation concerns.
    2. What happened52 minutes, against a permitted 45.
    3. The evidenceReadings and the sample, from the same records.
  3. 3

    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.
  4. 4

    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.

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

Qualio and Seal, side by side.

Every source is listed under References.

QualioSeal
What it isQuality, product lifecycle and compliance software¹The GxP execution system, with QMS built in
Built forPharma, biotech and medical devices¹Devices, diagnostics, drugs, biologics
Data modelControlled documents and the quality records linked to them²Primitives your team composes: record types, their relationships, steps and checks
AIDrafts CAPAs, change controls and quizzes in its records³Neil, Seal’s AI agent, prepares changes to the process; your team approves them
Configuring itTemplates, users and API set by plan⁴Your process, prepared from your procedures
Several sitesAn added instance per site or entity⁴Starts with one process; sites are added as you need them
Batches and equipmentRegisters fed from other systems⁵Run and recorded in Seal
TrainingAssigned from the documents⁶Qualification checked at the step
A corrective actionCAPA linked to change and training¹A tested change to the workflow
Getting startedUnder 60 days, Qualio says⁴A 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
Qualio is good for small life sciences companies formalising quality for the first time.⁴ Robert Fenton, a pharmacist who had worked in quality at Pfizer, founded it in Ireland in 2012,⁷ and in 2015 it sold an “all-in-one SOP, document control and training solution” to small and growing businesses.⁸ It is still built around controlled documents and the quality records linked to them: every document revision carries its own change control, and training is assigned from the documents themselves.²⁶ What a team can configure follows its plan: the entry plan includes five edit users and five quality event templates.⁴ Its AI, added from July 2024, drafts change summaries, training quizzes, CAPAs and change controls inside those records, each waiting for approval.⁹³ If the next audit is the whole job and your processes will hold still after it, it can work well. That is rare, and rarer now that the work changes so fast.

1What Qualio offers.

Qualio sells quality management, a regulated product lifecycle and compliance frameworks for life sciences, and says more than 700 customers use it.¹ Its quality side links policies, procedures, training, CAPAs, change, risk and suppliers, and a revised SOP reassigns its own training. Its product lifecycle side reads the work in Jira, GitHub and Azure DevOps and compiles technical documentation from approved work.¹ Batches, suppliers, parts and equipment are held as registers fed from the systems that own them, so quality events can link to them.⁵

Its AI arrived in stages: change summaries and training assessments for documents in July 2024,⁹ Compliance Intelligence, an assessment of the quality system against regulatory frameworks, in September 2025,¹⁰ and now a Copilot and agents that draft CAPAs, change controls and training quizzes for approval.³ It is sold in three plans, Foundation, “for companies formalizing quality for the first time”, Growth and Scale, starting at $25,000 a year, with guided implementation and document migration scoped by plan.⁴ G2’s summary of its reviews credits its interface and document control, and notes that the integrated editor has limited formatting and customisation options.¹¹

2Running Seal alongside Qualio.

Teams move to Seal one process at a time. Seal’s Qualio connection is set up per project on Qualio’s Developer API, using an administrator-issued token and the permitted resources, after confirming endpoint access and account requirements. In scope are the documents, events, suppliers, users and training data available through the Developer API.⁴ Start with read access; any change in Qualio needs separately configured actions and controls.

Once API access and mappings are configured, Neil can:

  • identify the training and quality-event context for a changed procedure;
  • bring supplier records and related quality events into a supplier review draft;
  • review the exposed event and training status fields and prepare an action summary for each owner.

Each connection records which system stays the source of truth while the move is under way.

3Moving from Qualio to Seal.

Start with one process.

  1. Choose a process where a procedure change has to reach the work, such as a test method that needs a practical assessment, or a step that should be blocked without current training.
  2. Bring the procedure, the roles that perform it, a representative record and the training evidence behind it. Start with sample material, or arrange an NDA before sharing confidential records.
  3. Neil proposes the workflow from that procedure, including the qualification checks, and your quality 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. Connect Qualio read-only for the documents and training records the process needs, and exercise the blocked paths: a superseded procedure, a missing assessment and an expired qualification.
  5. Agree which records move and which stay retrievable in Qualio. Within that scope, relationships, attachments, versions and available audit context are preserved, and representative records are reconciled and retrieval verified before you rely on the new workflow. Procedures can be imported in bulk as PDFs and converted to structured Seal documents as they are revised.

Retention obligations continue for the records that stay in Qualio. The training and document control blueprints show those workflows in detail.

References

  1. 1Quality, Product Lifecycle and Compliance for Life Sciences, Qualio. https://www.qualio.com/product (read 5 November 2026)
  2. 2Change Control Software for Life Sciences, Qualio. https://www.qualio.com/product/change-control-software (read 5 November 2026)
  3. 3AI Agents and Co-pilot, Qualio. https://www.qualio.com/compliance-platform/ai (read 5 November 2026)
  4. 4Plans and pricing, Qualio. https://www.qualio.com/pricing (read 5 November 2026)
  5. 5Qualio Integrations, Qualio. https://www.qualio.com/integrations (read 5 November 2026)
  6. 6Training Management Software for Life Sciences, Qualio. https://www.qualio.com/product/training-management-software (read 5 November 2026)
  7. 7Press Room, Qualio. https://www.qualio.com/press (read 5 November 2026)
  8. 8Qualio home page, Qualio, as archived on 22 November 2015. https://web.archive.org/web/20151122155432/https://www.qualio.com/ (read 5 November 2026)
  9. 9Faster, streamlined quality processes powered by AI in Qualio, Qualio, 5 July 2024. https://www.qualio.com/blog/qualio-ai (read 5 November 2026)
  10. 10Announcing: Compliance Intelligence, Qualio, 16 September 2025. https://www.qualio.com/blog/announcing-compliance-intelligence (read 5 November 2026)
  11. 11Qualio reviews, G2, as archived on 12 October 2026. https://web.archive.org/web/20261012114909/https://www.g2.com/products/qualio/reviews (read 5 November 2026)

AQuestions and answers

Is Seal better than Qualio?

Yes. Qualio is good for small life sciences companies formalising quality for the first time. Robert Fenton, a pharmacist who had worked in quality at Pfizer, founded it in Ireland in 2012, and in 2015 it sold an “all-in-one SOP, document control and training solution” to small and growing businesses. It is still built around controlled documents and the quality records linked to them: every document revision carries its own change control, and training is assigned from the documents themselves. What a team can configure follows its plan: the entry plan includes five edit users and five quality event templates. Its AI, added from July 2024, drafts change summaries, training quizzes, CAPAs and change controls inside those records, each waiting for approval. If the next audit is the whole job and your processes will hold still after it, it can work well. That is rare, and rarer now that the work changes so fast. 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, Skye Biologics cut non-conformances by 40%, with training checked before execution.

Is Seal an alternative to Qualio?

Yes. Qualio is built around controlled documents and the quality records linked to them. Seal covers documents, training, CAPA, nonconformances, complaints, change control, suppliers, audits, design controls and ISO 14971 risk, and runs the laboratory, batch records and device history records on the same records. It is configured from your procedures rather than limited by plan, a step can require current qualification, and a corrective action is released as a verified change to the workflow.

Is Seal a QMS for medical device and diagnostics companies?

Yes. Seal covers design controls, ISO 14971 risk management, CAPA, nonconformances, complaints, document control, training, suppliers, audits and device history records, for ISO 13485 and the FDA QMSR. Bioventix, working under ISO 13485, and Paradromics, which builds an implantable device, run their quality systems on Seal.

Can Seal work alongside Qualio?

Yes. Seal’s Qualio connection is set up per project on Qualio’s Developer API, with an administrator-issued token, and covers the documents, events, suppliers, users and training data the API exposes. It starts with read access, so Neil can bring Qualio records into procedure-change, supplier and follow-up reviews while you move processes to Seal.

How does training on a procedure change differ?

In Qualio, when a revised SOP is approved, everyone who trains on it is assigned the new version, and training plans follow roles. In Seal, the change record decides the response for each role and task, from awareness to requalification, and a step can be configured to require current qualification before it runs.

Does Qualio run laboratory or batch work?

Qualio’s products are quality management, the regulated product lifecycle and compliance frameworks, and it holds batches and equipment as registers fed from the systems that own them. In Seal, the laboratory, batch records and device history records run on the same records as the quality system.

What does each Qualio plan include?

Foundation includes five edit users and five quality event templates; Growth includes ten edit users and up to ten templates; unlimited templates come with Scale; MCP access comes with Growth and above; and a new site or entity is added as an instance. In Seal, adding a process, a site or a connection is a change you release, not an upgrade to a higher tier.

How does Qualio’s AI compare with Neil?

Qualio’s AI drafts records inside Qualio: gap assessments against regulatory frameworks, CAPAs, change controls from revised procedures and training quizzes, each waiting for approval, and it reads other systems without writing back to them. Neil prepares changes to the process itself: it configures the workflow from your procedure, assembles investigation evidence and drafts the configured change with its verification, for your team to approve. Neil never releases a change on its own, and in line with the EU’s draft GMP Annex 22 on AI, it is not used in GMP execution.

How long does it take to start with Seal?

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 Qualio.

Start with one process. Seal’s Qualio connection reads the documents and training records that process needs, so nothing has to move on day one.

Book a demo