Seal vs MasterControl

1MasterControl and Seal, side by side.

MasterControl and Seal both keep controlled quality records, and both can connect quality to manufacturing. They differ in what a quality decision can change. MasterControl sells quality, manufacturing and asset management as three suites on one platform.¹ In Seal, teams configure lab, manufacturing and quality workflows on one platform around a shared ontology, so a corrective action can be released as a verified change to the process that runs the next batch.

2What MasterControl is built for.

MasterControl is a packaged system for regulated manufacturers that want quality, production records and equipment management from one vendor. MasterControl Solutions, Inc., based in Salt Lake City, Utah, describes itself as a provider of cloud-based quality, manufacturing and asset management software for life sciences and other regulated industries.² It says more than 1,200 companies use it.³ In March 2025 it acquired Qualer, a calibration and maintenance software company, to add asset management to the same platform.⁴ It sells Quality Excellence in plans from basic document management to a complete digital QMS, and offers implementation, validation and integration services.⁵⁶

The software comes as three suites on what MasterControl calls its ADAPT platform:¹

• Quality Excellence (Qx): document control, change control, training, audit, risk and quality event management, with add-ons for supplier, postmarket, regulatory and clinical work.⁷
• Manufacturing Excellence (Mx): an MES with electronic batch records, device history records and electronic logbooks.⁷
• Asset Excellence (Ax): equipment calibration, maintenance and CMMS.⁷

Its quality event module, Advanced QEM, has a no-code form and workflow builder and templates for CAPA, deviation and management of change, which customers use as supplied or adapt.⁸ For laboratory data, MasterControl lists a LIMS among the systems it integrates with, alongside ERP.⁷ It serves pharmaceutical, biologics, cell and gene therapy and contract manufacturers, as well as medical device, food, dietary supplement and government customers.⁷

MasterControl builds AI tools into its quality and manufacturing software and says its AI platform is certified to ISO 42001. The tools include an Event Summarizer for quality events, a Deviation Analyzer, a Batch Assessor that predicts deviations and suggests corrective actions, a Master Template Generator for batch records, and tools that generate training exams and check SOPs against regulations.⁹ MasterControl describes them as human-in-the-loop: users review, edit and refine the summaries they produce.³

3How a corrective action reaches the work.

Both products link a CAPA to the records it affects. In MasterControl the path runs through connected modules; in Seal, one changeset carries the change to the workflow, its verification and its effectiveness review.

In MasterControl, a CAPA can be launched from another quality event and connected to MasterControl Documents.⁸ Change control routes, follows up, escalates and approves change orders, and keeps an automatic revision history with the reason for each change, when it was approved, who approved it and their signature.¹⁰ Training and exams can be launched automatically from document change control, CAPAs and production records.⁵ Where a site also runs Mx, production records sit on the same platform. Mx automates quality events during production to support review by exception,¹¹ and its Master Template Generator, released as a beta in May 2025, can revise an existing batch record template through a chat interface.¹² Validation on Demand can then test custom production records in the customer’s own environment.¹³

In Seal, the procedure, the workflow that runs it, the training and the controlled copies are records one change can reach, and a corrective action can be released as a change to the workflow itself. In the example in Seal’s change control blueprint, deviation DEV-018 records a 52-minute post-mix hold on batch B-041 against a 45-minute limit. The corrective action becomes changeset CC-019: master batch record MBR-014 v05 calculates the elapsed hold from the start and transfer timestamps and routes any hold over 45 minutes for assessment. CC-019 is verified with holds of 44, 45 and 46 minutes before release. Batch B-042 then runs the released version, B-041 keeps the version it ran against, and the effectiveness review measures whether hold exceptions recur over the agreed period.

Seal keeps the action, its verification and its effectiveness review as separate records, so implementing a change and showing that it worked are not one checkbox.

4How each keeps validation current.

Both vendors take a risk-based approach to validation and both automate testing of the configuration. The useful comparison is what evidence one change leaves behind.

MasterControl’s Validation Excellence Tool (VxT), introduced in 2018, generates validation documentation tailored to the customer’s risk profile, identifies high-risk areas that need more testing and delivers validation plans and summaries. With each upgrade, customers review only the new features that affect their critical processes. Validation on Demand (VoD), introduced in 2023, uses a test automation engine to validate the customer’s intended use in its own environment and configuration, and attaches the reports to the workflow. MasterControl also offers validation services for integrations, custom forms and data verification.¹⁴

In Seal, the URS, FS, DS and configuration specification are kept in the platform and linked to the released version. When a changeset is prepared for review, its selected user acceptance tests run, and publication requires current passing results for the required tests. Failures, corrections and retests stay with the candidate revision, and earlier runs keep the version they used, so after the next change a reviewer can see which evidence still applies and which checks must run again. An automated check supports your team’s release decision; it is not an independent declaration of compliance. The regulatory guide sets out the approach.

To compare the two in practice, ask each to take one configuration change from proposal to release, including a failed test and its retest, and inspect the evidence that remains afterwards.

5Where MasterControl is the better fit.

MasterControl is the better fit when you want an established, packaged quality system across a broad regulated business.

• You want document control, training and quality events from a vendor with more than 30 years in the field, with CAPA, deviation and change templates you can use as supplied.¹⁴⁸
• You are a US federal agency or contractor: MasterControl’s Quality Excellence Gov received FedRAMP Moderate authorisation in May 2025.¹⁵
• You run several kinds of regulated business, such as medical devices, blood and tissue, food or dietary supplements, alongside pharmaceuticals.⁷
• Your validation approach relies on supplier-generated documentation for each upgrade, which VxT is designed to produce.¹⁴
• You want AI tools for document work inside the eQMS, such as translating procedures into a dozen languages or generating training exams.⁹

6Where Seal is the better fit.

Seal is the better fit when you want what quality learns to change how the next batch runs, and to show whether it worked.

• Your laboratory, manufacturing and quality work should share one set of records. In Seal they use a shared ontology: a sample belongs to a batch, a result comes from a test, and an investigation links to the affected work. An out-of-specification investigation links back to the sample, method, instrument file and specification behind the result.
• You want a corrective action released as a verified change to the workflow, with its effectiveness measured on the runs that follow.
• You expect to keep changing the process. Each improvement becomes a new process version with its specifications, test evidence and approvals, and earlier runs keep the version they used.
• You want an AI agent to do the preparation. Neil configures the workflow from your procedure, assembles investigation evidence across records and connected systems, and drafts the CAPA and the configured change. People approve, Neil never releases a change on its own, and AI can be switched off for the whole organisation. 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.

7Running Seal alongside MasterControl.

You do not need to replace MasterControl to start. Seal’s MasterControl connection is set up per project on MasterControl’s API, so Neil can bring MasterControl quality records into investigations and prepare change-impact reports.

The connection is scoped through MasterControl’s API Toolkit or integration services, after confirming which Qx and Mx endpoints and field mappings are available in your environment. In scope are selected quality and document data exposed by your licensed MasterControl interfaces. Start with read access; any change in MasterControl needs separately configured actions and controls. On its side, MasterControl integrates other systems through its API Toolkit and the MuleSoft integration platform, with its own integration services.⁶

Once API access and mappings are configured, Neil 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 requested evidence for a review package and identify records that still need to be supplied.

Each connection’s scope also records which system stays the source of truth. For example, MasterControl can keep documents, training records and existing quality events while one process runs in Seal and reads the MasterControl records it needs.

8Moving from MasterControl to Seal.

Move one process first, and leave the rest in MasterControl until you decide otherwise.

1. Choose one recurring bottleneck, such as assembling deviation evidence, following actions through effectiveness review, 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 before sharing confidential records.
3. Neil proposes the workflow from that procedure: record structure, classification fields, investigation steps, roles and review gates. 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 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. Agree which records move and which stay retrievable in MasterControl. Within that scope, relationships, attachments, versions and available audit context are preserved, and representative records are reconciled and retrieval verified before you rely on the new workflow. Procedures can be imported in bulk as PDFs and converted to structured Seal documents as they are revised.

Retention obligations continue for the records that stay behind. As more laboratory, manufacturing and quality work moves onto the same records, fewer changes have to be carried by hand between systems. The QMS blueprint describes the quality workflows in detail.