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PAS-X runs master batch records in large plants. Seal runs the batch and everything around it.

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 increased throughput by 35%. Start with one process beside PAS-X MES.

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Where PAS-X MES falls short.

From Körber’s own pages and case studies.

  • SteriPack, “fast-track”
    9 months
    Unigen, “a record time”
    4 months after Fit
    Seal, a first process
    48 hours

    Months to go live.

    Körber calls a go-live four months after the Fit phase, at Unigen, “a record time”. Seal has a first process working for you to evaluate within 48 hours, once the scope is agreed and the inputs received.

    Körber, Unigen case study
  • Your recipes
    Körber’s specialists
    They
    “create, change and maintain”
    Seal
    Neil, then your approval

    Recipes by its specialists.

    Körber sells master batch record design in which its specialists “create, change and maintain your recipes”, to help customers “overcome talent scarcity”. In Seal, Neil configures the first process from your procedure, and your team approves it.

    Körber, MBR consulting
  • The batch
    PAS-X MES
    LIMS
    A third-party system
    CAPA
    Not on its product list
    In Seal
    One set of records

    The lab and quality live elsewhere.

    Körber’s PAS-X suite names no laboratory or quality product, and a LIMS connects as a third-party system. In Seal, the lab, the batch and quality are one set of records.

    Körber, Life sciences MES
  • Large sites
    PAS-X MES
    Smaller sites
    PAS-X Neo
    First version
    November 2026
    Seal
    The same platform

    Smaller sites get a separate product.

    In May 2026 Körber announced PAS-X Neo for smaller sites, where limited IT, validation and MES capacity make projects “difficult to start”. Seal is the same platform from a first process to commercial production.

    Körber, May 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

PAS-X MES and Seal, side by side.

Every source is listed under References.

PAS-X MESSeal
What it isPharma MES, begun by Werum in 1990¹The GxP execution system: your eBR, your QMS and more
Built forLarge, highly integrated sites²Process development, the lab, manufacturing, batch release and quality
Data modelThe master batch record, run as the EBR³Primitives your team composes: record types, their relationships, steps and checks
AIPAS-X K.AI: documentation answers, MBR updates from a prompt⁴⁵Neil, Seal’s AI agent, prepares changes to the process; your team approves them
Who configures itMBR designers, or Körber’s managed service⁶Your team, with Neil preparing it from your procedures
ScopeManufacturing execution²MES, LIMS and QMS on one platform
Setting up the recordGraphical MBR building blocks⁷Neil drafts it from your master batch record; your team approves
Testing a recipeSimulation toolkit before go-live⁷Selected tests run when a change is prepared for review; release needs them passing
Batch reviewDeviations flagged to QA³Exceptions shown on the step they concern
Lab resultsThrough LIMS and instrument interfaces⁸⁹Shown on the step they govern
Deviation to CAPACAPA not on its product list²Linked to the step and to the next process version
Getting startedMonths; four after the Fit phase was a “record”¹⁰A 48-hour evaluation of one process, once the scope is agreed and the inputs received
Smaller sitesA separate product, PAS-X Neo, due November 2026¹¹The same platform
UpgradesOne customer’s upgrade spanned ten versions¹²Seal’s releases come with supplier evidence; your team assesses each against its intended use

Summary

The story
PAS-X MES is good for executing master batch records in large, highly integrated plants.² Werum began building it in 1990, first for the tobacco company Reemtsma, and took it live in pharmaceutical production in 1994;¹ Körber bought the business in 2014.¹³ Its model is the master batch record, executed as the electronic batch record.³ Körber says its drag-and-drop tool models any pharma activity without coding skills,⁷ yet it sells specialists to “create, change and maintain your recipes”,⁶ calls a go-live four months after the Fit phase a record,¹⁰ and in 2026 announced a separate product, PAS-X Neo, for sites whose limited IT, validation and MES capacity make such projects hard to start.¹¹ Its AI, PAS-X K.AI, began in 2025 as a documentation chatbot and now prepares master batch record updates from a prompt, for a person to review.⁴⁵ If you make the same products in one large plant for years and can staff the projects, it can work well. That is rare, and rarer now that the work changes so fast.

1What PAS-X MES offers.

PAS-X MES is the MES that Werum began developing in 1990 and first took live in pharmaceutical production, at Jenapharm, in 1994.¹ Körber AG bought Werum IT Solutions in March 2014, and PAS-X is now sold by Körber Business Area Pharma.¹³⁴ Körber calls it its flagship, the solution of choice for large-scale, highly integrated manufacturing environments.² It is built around the master batch record: recipes are modelled in a graphical designer from reusable building blocks and tested in a simulation toolkit before go-live,⁷ then executed as electronic batch records, and during production it checks batch reports against their requirements, so that only records with detected deviations go to quality assurance.³

Körber says out-of-the-box templates and pre-configured content accelerate deployment and reduce validation effort.² Its own case studies show what fast means: a nine-month implementation at SteriPack is “fast-track”,⁷ and a go-live four months after the Fit phase at Unigen is “a record time”.¹⁰ In May 2025 Körber added PAS-X K.AI, a web-based AI chatbot that answers questions about PAS-X products with direct links to the documentation,⁴ and its AI page now says K.AI also accelerates master batch record updates “by simply stating a prompt”, with the AI handling the configuration for a person to review.⁵

2Running Seal alongside PAS-X MES.

You can start without replacing PAS-X MES. Seal connects the records a job needs, and the scope of each connection records which system owns them.

The routes are Seal’s REST API, which reads and writes records from another system, and Scripts, versioned Python that can call an external service after an event or on a schedule and is tested and published like other Seal records. The Seal IoT app can also collect exported files from a site computer or network share. On the PAS-X side, Körber lists open APIs for third-party systems such as LIMS.⁸

Teams typically move the laboratory or quality workflow around the batch into Seal first, or have Neil investigate a recurring exception from the records it is given, then move the batch record itself. Start with read access and treat any write-back as a separate decision. Qualify the connection by defining identifiers and field mappings, testing missing, delayed and duplicate records, and reconciling transferred records against the source, as the regulatory guide sets out.

3Moving from PAS-X MES to Seal.

Move one process first. PAS-X MES keeps running the rest until you move it.

  1. Choose a process where the master record changes often or an exception keeps recurring.
  2. Bring the procedure or master batch record, a representative batch and the records it touches. Use sample material, or arrange an NDA before sharing confidential records.
  3. Neil proposes the steps, fields, calculations, material and equipment requirements and review gates. Your process experts check the mapping and resolve assumptions. Once the scope is agreed and the inputs received, Seal prepares the first working configuration and its validation pack to evaluate within 48 hours.
  4. Exercise the failure paths before release: invalid material and equipment scans, limits and holds, deviations, signatures, and interface failure and recovery.
  5. Agree which records move and which stay retrievable in PAS-X MES, and reconcile representative records before you rely on the new workflow.

Production timing then depends on scope, interfaces, migration, operational readiness and your release requirements. Executed batch records keep their retention obligations wherever they stay. The electronic batch records blueprint describes the execution model in detail.

References

  1. 1Our milestones, 50 Years of Werum, Werum. https://history.werum.com/en/ (read 5 November 2026)
  2. 2Life sciences MES (PAS-X Suite), Körber. https://www.koerber.com/en/solutions/software-and-ai/life-sciences-mes (read 5 November 2026)
  3. 3Using PAS-X MES in digital pharmaceutical production, Körber. https://www.koerber.com/en/insights-and-events/pas-x-mes-digital-pharma-production (read 5 November 2026)
  4. 4New software products at Körber’s Software Pharma Open to digitalize pharmaceutical production, Körber, 20 May 2025. https://www.koerber.com/en/about-us/news-and-press/software-pharma-open-conference-pas-x-mes-system (read 5 November 2026)
  5. 5AI-powered acceleration (PAS-X K.AI), Körber. https://www.koerber.com/en/solutions/software-and-ai/life-sciences-mes/ai-powered-acceleration (read 5 November 2026)
  6. 6MBR consulting and implementation, Körber. https://www.koerber.com/en/solutions/consulting-and-implementation/mes-and-mom/pas-x/mbr (read 5 November 2026)
  7. 7Execute paperless manufacturing, Körber. https://www.koerber.com/en/solutions/software-and-ai/life-sciences-mes/digital-manufacturing/execute-paperless (read 5 November 2026)
  8. 8Digital integration (PAS-X MSI), Körber. https://www.koerber.com/en/solutions/software-and-ai/life-sciences-mes/digital-integration-msi (read 5 November 2026)
  9. 9Digital bridge between in-process control laboratories and pharmaceutical production, Körber, 19 September 2025. https://www.koerber.com/en/about-us/news-and-press/q-doc-by-sotax-certification (read 5 November 2026)
  10. 10Unigen implements PAS-X MES in only four months, Körber. https://www.koerber.com/en/insights-and-events/case-studies/unigen-pas-x-mes-implementation (read 5 November 2026)
  11. 11With PAS-X Neo, Körber announces an additional MES offering, Körber, 18 May 2026. https://www.koerber.com/en/about-us/news-and-press/pas-x-neo-entry-level-mes (read 5 November 2026)
  12. 12Almirall upgraded PAS-X MES for better performance, Körber, 19 September 2023. https://www.koerber.com/en/about-us/news-and-press/almirall-pas-x-mes (read 5 November 2026)
  13. 13Körber AG completes acquisition of Werum IT Solutions AG, Körber, 20 March 2014. https://www.koerber.com/en/about-us/news-and-press/werum-it-solutions-complete-acquisition (read 5 November 2026)

AQuestions and answers

Is Seal better than PAS-X MES?

Yes. PAS-X MES is good for executing master batch records in large, highly integrated plants. Werum began building it in 1990, first for the tobacco company Reemtsma, and took it live in pharmaceutical production in 1994; Körber bought the business in 2014. Its model is the master batch record, executed as the electronic batch record. Körber says its drag-and-drop tool models any pharma activity without coding skills, yet it sells specialists to “create, change and maintain your recipes”, calls a go-live four months after the Fit phase a record, and in 2026 announced a separate product, PAS-X Neo, for sites whose limited IT, validation and MES capacity make such projects hard to start. Its AI, PAS-X K.AI, began in 2025 as a documentation chatbot and now prepares master batch record updates from a prompt, for a person to review. If you make the same products in one large plant for years and can staff the projects, 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 increased throughput by 35% and cut non-conformances by 40%.

Is Seal an alternative to PAS-X MES?

Yes. PAS-X MES is designed for large, highly integrated plants. Seal runs electronic batch records, weigh and dispense, equipment checks and review by exception, on the same platform as laboratory testing, deviations, CAPA, change control and training. PAS-X MES executes the batch and connects to those systems through interfaces. In Seal each improvement is released as a tested new version of the process.

Is Seal an MES?

Yes. Seal executes GMP manufacturing from a versioned master batch record, with material, equipment and training checks at the step, in-process results linked to their specifications, and review by exception. Skye Biologics, MiAlgae and Paradromics run their batch records on Seal.

Who owns PAS-X, and is it still called Werum?

Körber AG owns PAS-X. Körber completed its acquisition of Werum IT Solutions, which developed PAS-X, in March 2014; the legal entity was renamed Körber Pharma Software GmbH in 2022, and the software is now sold by Körber Business Area Pharma.

Can Seal work alongside PAS-X MES?

Yes. Seal’s REST API, Scripts and file collection connect the records a job needs, starting with read access. Teams usually move a laboratory or quality workflow, or one process, into Seal first while PAS-X MES keeps running the rest.

How do recipe changes compare between PAS-X MES and Seal?

In PAS-X MES, authors change the master batch record in a graphical designer and can test it with a simulation toolkit, or Körber’s specialists maintain the recipes as a managed service. In Seal, a change is a new process version carrying its requirement, verification and approval, the batch in progress keeps its version, and publication requires current passing results for the required tests.

How does PAS-X K.AI compare with Neil?

PAS-X K.AI is Körber’s AI assistant for PAS-X. It was launched in May 2025 as a web-based chatbot that answers questions about PAS-X products with links to the documentation, and Körber now says it also updates master batch records from a prompt, with the configuration left for a person to review. Neil, Seal’s AI agent, prepares changes to the process itself, with their tests, for your team to approve, and in Seal that process includes the laboratory and quality steps around the batch. Neil 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 configuration and its validation pack to evaluate within 48 hours, configured from one of your procedures or master batch records. Production timing then depends on scope, interfaces, migration, operational readiness and your release requirements.

Start beside PAS-X MES.

Start with one process. Seal connects to PAS-X MES through its REST API and Scripts with read access, so nothing has to move on day one.

Book a demo