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MasterControl runs quality around controlled documents. Seal runs the work they describe.

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 MasterControl.

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Where MasterControl falls short.

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

  • MasterControl, live
    6.7 months
    Seal, a first process
    48 hours

    Months to go live.

    G2 puts MasterControl’s go-live at 6.7 months on average. Seal has a first process working for you to evaluate within 48 hours, once the scope is agreed and the inputs received.

    G2, June 2026
  • Your team
    5 roles
    MasterControl’s
    6 more
    Seal
    Neil, then your approval

    Configured by a services team.

    MasterControl adds its project manager, configuration consultant, validation specialist, architects, engineers and trainers to your own team. In Seal, Neil configures the first process from your procedure, and your team approves it.

    MasterControl, Implementation Services
  • 1992
    Document control
    About 2018
    Manufacturing
    2025
    Assets, with Qualer
    Between them
    Integration

    A document system, extended.

    MasterControl began in document control. Manufacturing came around 2018 and asset management with Qualer in 2025, joined by integration. In Seal, the lab, the batch and quality are one set of records.

    Deseret News, February 2023
  • A G2 reviewer
    “Outdated UI”
    The same review
    “Audit trail is behind several layers”

    Hard to learn.

    G2’s summary says reviewers “consistently note that the system can feel complex for new users until proper training and change management are in place”.

    G2, June 2026
  • SOP Analyzer
    Checks a procedure
    Event Summarizer
    Summarises an event
    Neil
    Drafts the change

    Its AI reads. Neil does the paperwork.

    SOP Analyzer checks procedures against regulations, and Event Summarizer summarises quality events. Neil prepares the change itself and the paperwork around it, for your team to approve.

    MasterControl, April 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

MasterControl and Seal, side by side.

Every source is listed under References.

MasterControlSeal
What it isQuality suite, with manufacturing and asset suites added later¹²The GxP execution system: your eBR, your QMS and more
Built forLife sciences manufacturers³Process development, the lab, manufacturing, batch release and quality
Data modelThe controlled document and the quality event⁴⁵Primitives your team composes: record types, their relationships, steps and checks
AISummarises quality events, checks SOPs against regulations⁶⁷Neil, Seal’s AI agent, prepares changes to the process; your team approves them
Who configures itMasterControl consultants with your staff⁸Your team, with Neil preparing it
Lab resultsThrough a LIMS it integrates with⁹LIMS and ELN on the same records
A corrective actionCAPA to change control and training¹⁰¹¹⁵A tested change to the workflow
ValidationTools included; consulting sold as a subscription¹²¹³Your team approves the intended use; selected tests run on each change prepared for review
Getting startedAbout 6.7 months to go live, per G2¹⁴A 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
MasterControl is good for controlled documents and the quality processes around them. It was formed in 1992 to help manufacturers comply with ISO standards, began in document control and turned to life sciences in 2002.⁴¹ Its quality system still runs from quality events to documents and training;⁵ its move into manufacturing began around 2018, and asset management came with the purchase of Qualer in 2025.¹² It says Advanced QEM breaks from rigid form templates and pre-defined data models,¹⁰ yet going live is a joint project with its configuration consultants, validation specialists and engineers,⁸ which G2 puts at 6.7 months on average.¹⁴ Its AI, SOP Analyzer in January 2026 and Event Summarizer in April 2026, checks procedures against regulations and summarises quality events for users to edit.⁷⁶ If you plan a formal rollout and your processes will hold still once it is done, it can work well. That is rare, and rarer now that the work changes so fast.

1What MasterControl offers.

MasterControl sells quality, manufacturing and asset suites, which it describes as one connected platform for life sciences manufacturers.³ Quality Excellence covers quality events, documents and training.⁵ Manufacturing Excellence covers production records (EBR and eDHR), MES and electronic logbooks, with no-code workflows.⁹ Its AI tools also assist with generating training exams and answer questions about regulations with in-line citations.⁵¹⁵

2Neil does the paperwork across MasterControl. You sign.

You can keep MasterControl. Seal’s MasterControl connection is set up per project on MasterControl’s API, scoped to the data your licensed interfaces expose, and starts with read access. Once it is configured, Neil, your AI agent, can:

  • compare selected quality events and draft a recurrence assessment with source references;
  • collect the affected document and quality records for a procedure change’s impact report;
  • assemble the evidence for a review package and name what is still missing.

People approve, Neil never releases a change on its own, AI can be switched off for the whole organisation, and Neil is not used in GMP execution.

3Start beside MasterControl.

  1. Choose one recurring bottleneck, such as assembling deviation evidence or keeping procedure changes connected to training.
  2. Bring one procedure, a representative event and the records it touches. Start with sample material, or arrange an NDA first.
  3. Neil proposes the workflow 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 MasterControl read-only for the records that process needs.
  5. As more processes move, agree which records move and which stay retrievable in MasterControl, and reconcile representative records before you rely on the new workflow. Retention obligations continue for what stays.

References

  1. 1This quiet Utah company has become a global life sciences software leader worth $1.3 billion, Deseret News, 17 February 2023. https://www.deseret.com/utah/2023/2/17/23589164/mastercontol-software-company-value-myriad-genetics-utah-tech (read 5 November 2026)
  2. 2MasterControl Acquires Qualer to Transform Asset Management for Life Sciences Companies, MasterControl, 3 March 2025. https://www.mastercontrol.com/news/mastercontrol-acquires-qualer/ (read 5 November 2026)
  3. 3Life Sciences Platform, MasterControl. https://www.mastercontrol.com/platform/ (read 5 November 2026)
  4. 4Exclusive: MasterControl Software Provides Efficiency, Transparency for Life Science Companies, BioSpace, 7 May 2019. https://www.biospace.com/exclusive-mastercontrol-software-provides-efficiency-transparency-for-life-science-companies (read 5 November 2026)
  5. 5Quality Excellence, MasterControl. https://www.mastercontrol.com/quality/ (read 5 November 2026)
  6. 6MasterControl Unveils AI-Powered Event Summarizer to Accelerate Quality Decision-Making in Life Sciences, MasterControl, 21 April 2026. https://www.mastercontrol.com/news/mastercontrol-ai-event-summarizer/ (read 5 November 2026)
  7. 7MasterControl Launches AI-Powered SOP Analyzer to Transform Compliance Management for Life Sciences Manufacturers, MasterControl, 27 January 2026. https://www.mastercontrol.com/news/mastercontrol-launches-ai-powered-sop-analyzer/ (read 5 November 2026)
  8. 8Implementation Services, MasterControl. https://www.mastercontrol.com/services/implementation/ (read 5 November 2026)
  9. 9Manufacturing Excellence, MasterControl. https://www.mastercontrol.com/manufacturing/ (read 5 November 2026)
  10. 10Advanced Quality Event Management System, MasterControl. https://www.mastercontrol.com/quality/quality-event-management-system/ (read 5 November 2026)
  11. 11Change Control Software, MasterControl. https://www.mastercontrol.com/quality/change-control-software/ (read 5 November 2026)
  12. 12Pricing, MasterControl. https://www.mastercontrol.com/pricing/ (read 5 November 2026)
  13. 13Software Validation for Life Sciences, MasterControl. https://www.mastercontrol.com/validation/ (read 5 November 2026)
  14. 14My Take On 9 Best Quality Management Software in 2026, G2, 26 June 2026. https://learn.g2.com/best-quality-management-software (read 5 November 2026)
  15. 15MasterControl Launches AI-Powered Regulatory Chat to Simplify Compliance Navigation for Life Sciences Manufacturers, MasterControl, 19 August 2025. https://www.mastercontrol.com/news/mastercontrol-launches-ai-powered-regulatory-chat-to-simplify-compliance-navigation-for-life-sciences-manufacturers/ (read 5 November 2026)

AQuestions and answers

Is Seal better than MasterControl?

Yes. MasterControl is good for controlled documents and the quality processes around them. It was formed in 1992 to help manufacturers comply with ISO standards, began in document control and turned to life sciences in 2002. Its quality system still runs from quality events to documents and training; its move into manufacturing began around 2018, and asset management came with the purchase of Qualer in 2025. It says Advanced QEM breaks from rigid form templates and pre-defined data models, yet going live is a joint project with its configuration consultants, validation specialists and engineers, which G2 puts at 6.7 months on average. Its AI, SOP Analyzer in January 2026 and Event Summarizer in April 2026, checks procedures against regulations and summarises quality events for users to edit. If you plan a formal rollout and your processes will hold still once it is done, 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.

Do we have to replace MasterControl?

No. Neil can work across MasterControl through a connection scoped to your licensed interfaces, starting with read access, and you can start one process in Seal beside it. As more processes move, you agree which records move and which stay retrievable, and reconcile representative records before relying on the new workflow.

Is Seal a LIMS and a batch record system as well as a QMS?

Yes. Seal’s LIMS, ELN, batch records and QMS run on the same records, so an out-of-specification investigation links directly to the sample, method, instrument file and specification behind the result. MasterControl connects to a separate LIMS through integration.

Does MasterControl run manufacturing too?

Yes, through its Manufacturing Excellence suite, which covers production records, MES and electronic logbooks. MasterControl began that effort around 2018, decades after it started in document control, and bought its asset management software, Qualer, in 2025. In Seal, batch records, laboratory testing, equipment and the quality system are one set of records your own team configures.

How does MasterControl’s AI differ from Neil?

SOP Analyzer, launched in January 2026, checks SOPs against regulatory requirements, and Event Summarizer, announced in April 2026, drafts summaries of quality events that users review. Neil works across Seal’s records and connected systems to assemble investigation evidence and prepare changes to the process itself, for your team to approve. Neil is not used in GMP execution.

How long does it take to start with Seal compared with MasterControl?

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. G2’s Summer 2026 Grid Report puts MasterControl’s average time to go live at 6.7 months. Production timing in Seal then depends on scope, interfaces, migration and your release requirements.

Start beside MasterControl.

Keep MasterControl. Neil can work across it through Seal’s MasterControl connection, and you start with one process in Seal beside it, so nothing has to move on day one.

Book a demo