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Opcenter records batches beside Siemens automation. 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 Opcenter Execution Pharma.

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Where Opcenter Execution Pharma falls short.

From Siemens’ own pages, release notes and marketplace.

  • Siemens says
    No specific IT skills
    Its release notes
    An engineering phase
    Custom functions
    Managed script extensions
    Seal
    Neil, then your approval

    Configured in an engineering phase.

    Siemens says no specific IT skills are needed, yet its release notes describe an engineering phase, rollout programmes and managed script extensions. In Seal, Neil configures the first process from your procedure, and your team approves it.

    Siemens, December 2025
  • Its marketplace
    Partner implementation teams
    Their work
    “design, engineer and deploy”
    Seal, a first process
    48 hours

    Deployed by partner teams.

    A partner on Siemens’ marketplace has “the team in place to design, engineer and deploy” its projects. Seal has a first process working for you to evaluate within 48 hours, once the scope is agreed and the inputs received.

    Siemens, Technord implementation services
  • The batch record
    Opcenter Execution Pharma
    Lab results
    Opcenter Laboratory
    CAPA, change control
    Not among its functions
    In Seal
    One set of records

    The lab and quality sit elsewhere.

    CAPA, change control, document control and training are not among the functions Siemens lists, and the laboratory is reached through Opcenter Laboratory. In Seal, the lab, the batch and quality are one set of records.

    Siemens, Opcenter Execution Pharma
  • 2009
    Siemens buys Elan’s XFP
    Then
    SIMATIC IT eBR
    Today
    Opcenter Execution Pharma
    Its centre
    The master batch record

    Bought in 2009, built around the batch record.

    Siemens built SIMATIC IT eBR, now Opcenter Execution Pharma, on Elan’s XFP, bought in 2009, and calls it master batch record-driven. In Seal, your team composes record types, their relationships, steps and checks.

    SA Instrumentation & Control, October 2016
  • Its weighing client
    “legacy”
    Still used for
    “not yet covered scenarios”
    Seal
    In the browser

    Parts still run on a rich client.

    Siemens calls its rich-client weighing application “legacy”, and it “remains available for more advanced or not yet covered scenarios”. Seal runs in the browser for every role.

    Siemens, June 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

Opcenter Execution Pharma and Seal, side by side.

Every source is listed under References.

Opcenter Execution PharmaSeal
What it isSiemens pharma eBR on Elan’s XFP, bought in 2009¹The GxP execution system: your eBR, your QMS and more
Built forElectronic batch records for pharma²Process development, the lab, manufacturing, batch release and quality
Data modelThe master batch record, fed by the automation recipe³Primitives your team composes: record types, their relationships, steps and checks
AISmart Operation Designer drafts work instructions from documents⁴Neil, Seal’s AI agent, prepares changes to the process; your team approves them
Who configures itEngineers and Siemens partners⁵⁶Your team, with Neil preparing it from your procedures
Closest linkSIMATIC PCS 7 and SIMATIC Batch²Lab and quality records
The recipeProcess Instructions and EWIs⁷⁵A versioned master batch record
A changeNew Process Instruction version⁵A new process version, released with its tests
Batch reviewAlerts signed via signatory paths⁵Exceptions shown on the step they concern
Lab resultsOpcenter Laboratory integration²Shown on the step they govern
Deviation to CAPANot among the functions it lists²Linked to the step and to the next process version
InterfaceWeb apps, with a rich-client weighing application Siemens calls legacy⁴Browser-based
Getting startedEngineering projects with partners⁶⁸A 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
Opcenter Execution Pharma is good for electronic batch records beside Siemens automation.² It began as XFP, a pharmaceutical MES from the French company Elan Software Systems, which Siemens bought in 2009 and built SIMATIC IT eBR on,⁹¹ the product’s former name.⁷ Its model is the master batch record, which takes its values from the automation recipe.³ Siemens says users can design any process without specific IT skills,⁷ yet Process Instructions are built in an engineering phase and moved between environments in rollout programmes,⁵ and its marketplace sells partner teams to design, engineer and deploy the projects.⁶⁸ Its AI, Smart Operation Designer, arrived in June 2026 and turns legacy process documents into executable work instructions: AI for authoring the recipe, inside the model the product was built around.⁴ If your plants run Siemens control and your processes are settled, it can work well. That is rare, and rarer now that the work changes so fast.

1What Opcenter Execution Pharma offers.

Opcenter Execution Pharma, formerly SIMATIC IT eBR, is sold by Siemens Digital Industries Software.⁷ Siemens built SIMATIC IT eBR on the engine of XFP, the pharmaceutical MES of Elan Software Systems, a 60-person French company it bought in 2009 to supplement its own SIMATIC IT MES portfolio.¹⁹ Siemens describes it as master batch record-driven, with the master batch record taking its values directly from the automated recipe and review of the batch record by exception.³ It lists master batch records, material management, weighing and dispensing, electronic batch records with deviation management, equipment management, packaging, and automation and enterprise integration, including native integration with SIMATIC PCS 7 and SIMATIC Batch.²

Siemens says the system offers easy configuration and out-of-the-box functionality, “allowing users to design any process without specific information technology (IT) skills”.⁷ Its release notes describe the work in other terms: an engineering phase, rollout programmes and managed script extensions for process-specific requirements.⁵ Release 2605, in June 2026, added Smart Operation Designer, which Siemens says brings AI-assisted capabilities to the design of electronic work instructions, using AI-powered PDF processing to turn legacy process documents into structured, executable manufacturing instructions, with an integrated copilot that helps users refine them; the same release added an AI-based documentation assistant for product knowledge.⁴

2Running Seal alongside Opcenter Execution Pharma.

You can start without replacing Opcenter. Seal connects the records a job needs, and each connection’s scope records which system owns them.

Seal’s REST API reads and writes records from another system, and Scripts are versioned Python that can call an external service after an event or on a schedule, changed and tested like other Seal records. On the Siemens side, Opcenter Execution Pharma offers interfaces and standard connectors to other business and manufacturing systems, and Process Instructions can be imported via API.²⁴ For process values, Seal’s Siemens S7 and OPC UA pages describe what each of those routes collects and what it does not.

Teams typically move a laboratory or quality workflow 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, agree the source of record and treat any write-back as a separate decision. The regulatory guide sets out how to qualify the connection: identifiers, field mappings, missing and duplicate records, and reconciliation against the source.

3Moving from Opcenter Execution Pharma to Seal.

Move one process first. Opcenter Execution Pharma keeps running the rest until you move it.

  1. Choose a process whose master record changes often, or whose exceptions keep returning to the same step.
  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, and your process experts check the mapping. 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 version resolution for a new order, valid and invalid scans, limits, holds and deviations, signatures and verifier rules, and recovery from an interface failure.
  5. Agree which records move and which stay retrievable in Opcenter Execution Pharma, and reconcile representative records before relying on the new workflow.

Production timing then depends on scope, interfaces, migration, operational readiness and your release requirements. The MES blueprint describes how a run, its review and its next version work in Seal.

References

  1. 1Lean approach to paperless manufacturing (Siemens South Africa), SA Instrumentation & Control, October 2016. https://www.instrumentation.co.za/55572n (read 5 November 2026)
  2. 2Opcenter Execution Pharma: the platform to win the race against time, Siemens. https://www.siemens.com/en-us/campaigns/pharma-industry-opcenter-execution/ (read 5 November 2026)
  3. 3Opcenter Execution Pharma, Siemens. https://www.siemens.com/en-us/products/opcenter/execution/pharma/ (read 5 November 2026)
  4. 4What’s new in Opcenter Execution Pharma 2605, Alessandro Cereseto, Siemens Digital Industries Software, 15 June 2026. https://blogs.sw.siemens.com/opcenter/whats-new-in-opcenter-execution-pharma-2605/ (read 5 November 2026)
  5. 5What’s new in Opcenter Execution Pharma 2511, Siemens Digital Industries Software, 10 December 2025. https://blogs.sw.siemens.com/opcenter/whats-new-in-opcenter-execution-pharma-2511/ (read 5 November 2026)
  6. 6Opcenter Execution Pharma Implementation Services, sold by Technord Belgium, Siemens, as archived on 2 October 2026. https://web.archive.org/web/20261002122148/https://www.siemens.com/en-us/products/technord-belgium-opcenter-execution-pharma-implementation-services/ (read 5 November 2026)
  7. 7Opcenter Execution Pharma version 6.2.3 fact sheet, Siemens Digital Industries Software, 2021. https://www.plm.automation.siemens.com/media/global/en/Siemens%20SW%20Opcenter%20Execution%20Pharma%20version%206-2-3%20Fact%20Sheet_tcm27-40138.pdf (read 5 November 2026)
  8. 8Opcenter Execution Pharma Implementation Service, sold by AG Solution, Siemens. https://www.siemens.com/en-us/products/ag-solution-opcenter-execution-pharma-implementation-service/ (read 5 November 2026)
  9. 9Siemens acquires French MES vendor Elan, Control Global, 7 April 2009. https://www.controlglobal.com/manage/systems-integration/news/11371553/siemens-acquires-french-mes-vendor-elan (read 5 November 2026)

AQuestions and answers

Is Seal better than Opcenter Execution Pharma?

Yes. Opcenter Execution Pharma is good for electronic batch records beside Siemens automation. It began as XFP, a pharmaceutical MES from the French company Elan Software Systems, which Siemens bought in 2009 and built SIMATIC IT eBR on, the product’s former name. Its model is the master batch record, which takes its values from the automation recipe. Siemens says users can design any process without specific IT skills, yet Process Instructions are built in an engineering phase and moved between environments in rollout programmes, and its marketplace sells partner teams to design, engineer and deploy the projects. Its AI, Smart Operation Designer, arrived in June 2026 and turns legacy process documents into executable work instructions: AI for authoring the recipe, inside the model the product was built around. If your plants run Siemens control and your processes are settled, 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 Opcenter Execution Pharma?

Yes. Opcenter Execution Pharma is designed for pharmaceutical batch records. 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. Each improvement is released as a tested new process version, and earlier batches keep the version they ran.

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.

What was SIMATIC IT eBR?

SIMATIC IT eBR is the former name of Opcenter Execution Pharma, which Siemens Digital Industries Software sells as electronic batch records for the pharmaceutical industry. Siemens built it on the engine of XFP, the pharmaceutical MES of Elan Software Systems, which Siemens bought in 2009.

Can Seal work alongside Opcenter Execution Pharma?

Yes. Seal’s REST API and Scripts connect the records a job needs, starting with read access, and each connection names the system of record. Teams usually move a laboratory or quality workflow, or one process, into Seal first while Opcenter keeps running the rest.

Does Opcenter Execution Pharma include CAPA and change control?

Opcenter Execution Pharma is designed for pharmaceutical batch records. Siemens lists deviation management within its electronic batch records, but CAPA, change control, document control and training are not among the functions it lists, and laboratory work is reached through integration with a separate product, Opcenter Laboratory. Siemens sells quality management separately, as Opcenter Quality. In Seal, deviations, CAPA, change control and training run on the same records as the batch.

How does Opcenter Execution Pharma’s AI compare with Neil?

Siemens added Smart Operation Designer in Opcenter Execution Pharma 2605, in June 2026. Siemens says it uses AI to turn legacy process documents into structured, executable manufacturing instructions, with an integrated copilot that helps users refine the generated instructions, and the same release added an AI documentation assistant for product knowledge. That AI works on the work instructions inside Opcenter’s recipe model. 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 Opcenter Execution Pharma.

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

Book a demo