Seal vs Körber PAS-X MES

1PAS-X MES and Seal, side by side.

PAS-X MES and Seal both execute GMP manufacturing from an approved master batch record, and both direct review to exceptions. They differ in what surrounds the batch record. PAS-X MES is a dedicated manufacturing execution system that connects to ERP, LIMS, warehouse and automation systems through standard interfaces.¹ In Seal, teams configure lab, manufacturing and quality workflows on one platform around a shared ontology, so a result, a deviation and the next version of the process are records in the same system.

2What PAS-X MES is built for.

PAS-X MES is built for pharmaceutical, biotech and cell and gene therapy manufacturers that want a pharma-specific MES as the digital backbone of large, integrated plants. Körber calls it its flagship MES and “the solution of choice for large-scale, highly integrated manufacturing environments”.² It says eight of the ten largest pharma companies use it,³ and in May 2025 it marked its 500th major PAS-X MES facility go-live, at CELLforCURE by SEQENS in Les Ulis, France.⁴

The software was developed by Werum IT Solutions of Lüneburg, Germany. Körber AG completed its acquisition of Werum IT Solutions in March 2014,⁵ and PAS-X is now sold by Körber Business Area Pharma; Körber AG is the holding company of the Körber Group.⁶ Körber still uses the Werum PAS-X name in some material.⁷

The suite is modular:

• Electronic Batch Recording: master batch records (MBRs) are built in a graphical drag-and-drop designer from standardised, reusable building blocks, and generic MBRs define parameters instead of values to reduce the number of recipes to maintain.⁸
• Equipment Management: web-based state diagrams track cleaning, sterilisation and maintenance, and timers and counters mark equipment unusable when a limit expires.⁸
• Weighing and dispensing, MBR creation and real-time KPI and OEE recording, also offered as separate entry-level modules.⁹
• Integration: message-based shop-floor integration compatible with OPC UA, pre-configured SAP ERP interfaces and open APIs for LIMS, WMS and serialisation, with certified technology partners.¹
• Data: PAS-X Data Access gives analytics teams version-controlled access to MES data, and PAS-X Savvy adds dashboards for exceptions and batch record review times and supports semi-automated continued process verification.⁶

PAS-X MES runs on-premise, in a private cloud or as a fully managed SaaS.¹⁰ Version 3.4.2, released on 26 August 2026, added chain-of-identity and chain-of-custody support for cell and gene therapy and SmartInstall, which automates deployments, updates, validation checks and reporting.¹¹ For small and mid-sized companies and sites, Körber announced PAS-X Neo in May 2026, a cloud-native SaaS MES with standardised templates and pre-validated building blocks, with its first version due in November 2026.¹²

3How a master batch record changes.

Both products treat the master batch record as the controlled definition of the work. The difference is how a change is prepared and what evidence travels with it.

In PAS-X MES, authors model the recipe in the graphical designer and test it with a simulation toolkit before go-live, and during production the system blocks unauthorised entries.⁸ Körber also offers MBR services, from a help desk to managed design in which its specialists create, change and maintain recipes for the customer.¹³ Its AI assistant, PAS-X K.AI, can start an MBR update from a prompt and prepare the configuration for review, keeping a human in the loop and documenting each change.¹⁴ Körber’s validation service applies a risk-based Computer Software Assurance approach with predefined validation documentation.¹⁵

In Seal, Neil prepares a change from the evidence of the runs, and the change carries its own verification. In the example in Seal’s MES blueprint, the step 07 hold has lengthened over four batches, and only batch B-041 is over the 45-minute limit; deviation DEV-018 is linked to that step. Neil compares timestamps, procedure versions, results and linked deviations across the four batches. The next question is whether the receiving team was ready when each hold began, so Neil proposes a readiness check as a change to assess and test. The limit stays in place, and the source records do not establish a cause.

The proposed v05 carries its requirement, its tests and its approval. Verification covers the blocked path when the acknowledgement is missing and the permitted path when it is recorded, and the results, exceptions and approval stay with the new version. The batch in progress keeps v04. Approval authorises the new process; the runs that follow show whether it worked. The URS, FS, DS and configuration specification stay linked to each version, and publication requires current passing results for the required acceptance tests.

4How batch evidence reaches review.

Both products direct quality review to exceptions. In PAS-X MES the batch record is checked against its own rules; in Seal the batch, its laboratory results and its quality events are records on one platform.

Körber describes PAS-X MES checking batch reports during production and approving those that meet their requirements, so that only records with detected deviations go to quality assurance.⁹ Version 3.4’s NextGen Shopfloor covers order execution and order review for equipment-related activities, and configurable approval workflows with a dashboard take reviewers straight to deviations.¹⁶⁸ Laboratory data arrives through interfaces: in September 2025 Körber certified SOTAX’s q-doc software to send in-process control results, such as tablet hardness and friability, into PAS-X MES.¹⁷

In Seal, review by exception brings forward a failed check, an out-of-range result, a missing approval or a documented departure, and the full execution history stays available. An in-process test belongs to its batch and operation, with the sample, method, specification and result linked, and the next operation can depend on that result. DEV-018 carries the original timestamps and the applicable requirement into review, and the investigation, the CAPA and any change to the master record stay connected to it. Batch disposition remains a separate, authorised decision.

5Where PAS-X MES is the better fit.

PAS-X MES is the better fit when you want an established, pharma-specific MES as the standard across large, highly automated plants.

• You run large, integrated sites and want the MES Körber positions for that scale, with more than 35 years of pharma domain experience behind it.²
• You need deep equipment integration: PAS-X MSI connects machines through standardised interfaces and a programme of certified technology partners.¹
• You need a choice of deployment, including on-premise and private cloud.¹⁰
• You want packaging and serialisation from the same vendor, through PAS-X Track & Trace.⁶
• You make cell and gene therapies and want chain of identity and chain of custody handled in the MES.¹¹
• You would rather the vendor designed and maintained your MBRs as a managed service.¹³

6Where Seal is the better fit.

Seal is the better fit when the batch record should sit with the laboratory and quality work it depends on, and when the process will keep changing.

• Manufacturing execution, laboratory, quality, training and inventory share one platform, so a result, deviation or material lot links to the step it concerns.
• Each improvement becomes a new process version with its specifications, test evidence and approvals, and earlier runs keep the version they used. This suits processes that are still moving, such as clinical manufacturing or a recent tech transfer.
• Neil configures the first version from your procedure or master batch record, answers batch questions with sources and prepares the next change with its tests. In line with the EU’s draft GMP Annex 22 on AI, Neil is not used in GMP execution. It helps set up configuration, which your team verifies and releases under change control.
• You can start with one process alongside the systems you run and extend on the same platform.

7Running Seal alongside PAS-X MES.

Seal has no dedicated PAS-X connector. Where an existing MES stays in place, Seal connects the records a job needs and the scope 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 and PAS-X Data Access for curated MES data.¹⁶

A common arrangement keeps PAS-X MES executing batches while Seal runs a laboratory or quality workflow, or while Neil investigates a recurring exception from the records it is given. 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.

8Moving from PAS-X MES to Seal.

Move one process first, and keep PAS-X MES as the record for the rest.

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 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.