Seal vs Rockwell FactoryTalk PharmaSuite

1FactoryTalk PharmaSuite and Seal, side by side.

FactoryTalk PharmaSuite and Seal both execute electronic batch records with weighing, in-process checks and review by exception. They differ in how the record is assembled and what it is joined to. PharmaSuite builds master recipes from standard building blocks to ISA-88 and ISA-95 and integrates with ERP and the automation layer.¹ In Seal, teams configure lab, manufacturing and quality workflows on one platform around a shared ontology, so an in-process result, its specification and the quality decision about it are records in the same system.

2What FactoryTalk PharmaSuite is built for.

FactoryTalk PharmaSuite is built for pharmaceutical and biopharmaceutical manufacturers that want a standard MES whose out-of-the-box content they can configure and extend.² Rockwell Automation, Inc., based in Milwaukee, Wisconsin, launched version 12.00 in May 2025 and says the product builds on more than 15 years of continuous development.³ Rockwell describes an open-content architecture with role-based optimisation for each lifecycle stage and an intelligent upgrade engine, for both batch and discrete processing.¹

Rockwell lists these capabilities:¹

• Resource management that tracks materials, equipment and personnel within the electronic batch record.
• Weighing and dispensing with support for pre-weighing scenarios, embedded in the modular electronic batch recording.
• Master recipes to ISA S88 and S95, with standard building blocks covering batch records for API, biotech, bulk manufacturing and packaging.
• Exception management with a quality dashboard that gives a real-time view of the shop floor and supports review by exception.
• Cold chain tracking that defines temperature and time limits for thermo-sensitive materials, tracks how long each sublot spends in each temperature range and notifies operators as a sublot nears its usable limit.
• Integration with business and operational systems and the automation layer, and cybersecurity services aligned with the NIST Cybersecurity Framework.

Operators and recipe authors see different screens, set by their role, and partners and customers can build their own functional blocks with a Software Development Kit.² Version 12.00 runs in Kubernetes using Linux containers, adds a set-up tool called MICKA that automates installation and validation steps, adds centralised monitoring and a new upgrade engine, and can be deployed in the cloud, on-premise or in hybrid models.³ Rockwell names Rottendorf Pharma, a German contract manufacturer of solid doses, as a customer using PharmaSuite for weigh-and-dispense data and end-to-end electronic batch recording.¹

3How an in-process check is set up and reviewed.

Both products build in-process controls into execution rather than leaving them to the operator’s memory. PharmaSuite models the check and its timing into the recipe; Seal makes each check a record linked to its sample, method and specification.

In PharmaSuite, in-process control checks are modelled into the recipe, and since version 6.0 the recipe designer’s building block library lets programmers reuse and maintain a modelled check across recipes. Escalation management watches the timing: for a check due within a five-minute window every 30 minutes, the operator is alerted when the window opens and warned if the check is not done, and the activity, with any exceptions or deviations, is recorded in the batch record for quality assurance.⁴ The quality dashboard supports review by exception,¹ and Rockwell recommends starting review at the moment the MES detects an exception, with a red flag on a Batch Record Review dashboard, rather than waiting for the batch to finish.⁵

In Seal, an in-process test is a record of its own that belongs to a specific batch and operation, linked to its sample, method, specification and result, and the workflow can make the next operation depend on it. In the example in Seal’s MES blueprint, an in-process result of pH 7.10 meets the example range, yet step 13 stays blocked until the review is recorded: an acceptable number and an authorised decision are distinct records. Weighing works the same way. A scanned container is checked for material, expiry, quarantine status and grade, and a grade mismatch halts the step rather than raising a warning to dismiss.

4How a recipe or specification changes.

Both products separate the definition from the batches that ran against it. The difference is what a change carries with it when it is released.

In PharmaSuite, recipes are assembled from reusable building blocks, and predefined workflows created up front can be selected, executed and documented by operators during production, then appended to the electronic batch record.⁴ Out-of-the-box content can be combined with a customer’s additions without modifying the process, and upgrades preserve existing master data and batch records in a documented process.²

In Seal, the change carries its applicability and evidence. In the example in Seal’s specification management blueprint, specification SP-042 v06 is proposed while sample S-042-18 is in progress against v05 and certificate COA-042-17 has been issued against v05. The proposal does not change the sample’s limits or methods, and the certificate keeps the version it was issued with; a correction would be a controlled amendment, not a regeneration. Version 06 is assigned to future testing only after the change and applicability review has covered product, stage, site, market, method references and implementation conditions.

The same rule applies to the master batch record. Each improvement becomes a new process version with its specifications, test evidence and approvals; selected acceptance tests run when the changeset is prepared for review, publication requires current passing results, and earlier runs keep the version they used.

5Where FactoryTalk PharmaSuite is the better fit.

FactoryTalk PharmaSuite is the better fit when you want a configurable pharma MES from your automation supplier, extended by your own engineers or partners.

• Your plant runs on Rockwell automation and you want the MES from the same supplier, with integration to the automation layer and ERP.¹²
• You want to build your own functional blocks with a Software Development Kit, or have a system integrator do so.²
• You need weighing with pre-weighing scenarios and recipe building blocks that cover API, biotech, bulk and packaging.¹
• You handle thermo-sensitive materials and want cold chain time tracked per sublot inside the MES.¹
• You need a choice of cloud, on-premise or hybrid deployment, with containerised components and a new upgrade engine.³
• You want operational technology cybersecurity services from the same company.¹

6Where Seal is the better fit.

Seal is the better fit when in-process results, specifications and quality decisions should live on the same records as the batch, 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.
• Specifications, methods and master records are versioned with their applicability, so each sample, certificate and batch keeps the version assigned to it.
• Neil configures the process from your procedure or master batch record, answers batch questions with sources and prepares changes with their 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 FactoryTalk PharmaSuite.

Seal has no dedicated PharmaSuite connector. Where an existing MES stays in place, 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, edited in a changeset and tested like other Seal records. Where the process data behind PharmaSuite batches is kept in a PI historian, Seal’s AVEVA PI connection captures a tag reading or a completed period of up to seven days as a reference, with source timestamps, units and quality flags, through a read-only PI Web API gateway. Rockwell added native integration with FactoryTalk Historian and the OSIsoft PI System to PharmaSuite in version 5.2.⁶

A common arrangement keeps PharmaSuite executing batches while Seal runs the laboratory testing or the quality workflow around them, or while Neil investigates a recurring exception from the records it is given. Start with read access, and treat write-back as a separate decision with defined actions, review gates and audit evidence, as the regulatory guide sets out.

8Moving from FactoryTalk PharmaSuite to Seal.

Move one process first, and keep PharmaSuite as the record for the rest.

1. Choose a process where in-process results and specifications change often, or where review keeps stopping on the same exceptions.
2. Bring the procedure or master batch record, the specification, 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, sampling points, 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 within 48 hours.
4. Exercise valid and invalid scans, in-process results inside and outside their limits, holds, deviations and signatures before release.
5. Agree which records move and which stay retrievable in PharmaSuite. Rockwell added export of production orders and electronic batch records in PDF and B2MML for long-term archival in version 5.2.⁶

Production timing then depends on scope, interfaces, migration, operational readiness and your release requirements. The electronic batch records blueprint describes how Seal executes and reviews a batch.