Seal vs Greenlight Guru

1Greenlight Guru and Seal, side by side.

Greenlight Guru and Seal serve different regulated businesses, and the comparison starts there. Greenlight Guru builds quality management, product development and clinical data software for medical device companies, and says it builds only for them.¹ Seal is the GxP operating system for biopharma: in Seal, teams configure lab, manufacturing and quality workflows on one platform around a shared ontology, and it also runs device design, manufacturing and quality records, so a design change can be followed to the units already built.

2What Greenlight Guru is built for.

Greenlight Guru is built for medical device teams that want design controls, risk, quality processes and clinical evidence in one system made for medtech. Jon Speer, a medical device engineer turned consultant, had the idea in 2006 and developed it with his co-founder, David DeRam. In 2022 the company acquired SMART-TRIAL, an electronic data capture provider, and it has also acquired Vertex Intelligence, a data consultancy that has helped bring AI into its products.² It is based in Indianapolis and backed by JMI Equity,³¹ and it says more than 1,000 medical device companies use its software.⁴

Its platform has three parts:⁴

• Quality management: document management with change and training, quality events such as CAPAs, audits and nonconformances, and supplier and parts management.
• Product development: requirements management linking user needs, requirements and verification to design controls, software release management from development tools, and ISO 14971 risk management.
• Clinical evidence: electronic data capture for clinical trials, post-market clinical follow-up planned to EU MDR expectations, and ePRO and eCOA.

Its design controls use a multi-level traceability matrix, run design reviews in Part 11 workflows and generate the design and development file from the linked records.⁵ Risk management links design controls and documents to risks as control measures, documents hazards and harms with IMDRF codes and classifies risk against an acceptability matrix.⁶

Greenlight Guru AI includes search across the QMS with linked source references, chat with QMS data, document summaries, a verifiability check that flags requirements that cannot be tested, brainstorming for design controls and risks, suggested traceability links, a training quiz builder, change order summaries and a clinical agent. Greenlight Guru says every output is a suggestion the team reviews and approves before it is saved or acted on, and that customer data is never used to train external models.⁷⁴ In June 2026 it announced ISO/IEC 42001 certification for AI governance across its eQMS and EDC products.¹

3How a design change reaches the devices already built.

Both products connect a design change to the records it affects. Greenlight Guru carries that connection across design and quality documentation; Seal carries it on to the units built under each revision.

In Greenlight Guru, change orders are reviewed and approved with e-signatures and routed across document control, quality, product development, manufacturing and operations. Each change generates a document listing the documents impacted, approvers, approval date, effective date, signatures and descriptions, and changes are connected across design and quality documentation.⁸ The traceability matrix links design inputs, outputs, verifications and product risk controls.⁴

In the illustrative infusion pump on Seal’s medical device blueprint, requirement REQ-047 sets flow accuracy within ±3%. Its design output is impeller specification DV-103 v02, verified by bench protocol VER-047 at 2.1%, and it controls HAZ-023, incorrect dosing. Change CHG-031 proposes a revised impeller, DV-103 v03, which brings VER-047 back for repeat and HAZ-023 into review. The same links show the 176 units already built on DV-103 v02, serials 0412 to 0587, whose field action is still to be assessed.

That last step depends on the manufacturing record. In Seal the manufacturing traveller runs as an electronic batch record, so each unit links to the versions and lots it was built from, and a current drawing is never taken to describe a unit made under an earlier revision. Paradromics runs the manufacturing travellers and quality records for its brain-computer interface in Seal.

4Devices, drugs and the products in between.

The products divide along the kind of company they serve. That matters most where a device sits beside GMP manufacturing.

Greenlight Guru keeps its scope to medical devices, from design through clinical evidence to post-market quality.¹⁴ Its validation follows the same focus. For each product update, customers are notified and the validation package is updated; it is built to reflect computer software assurance and ISO/TR 80002-2:2017. Customers review the intended-use statements in the validation test report against their own use, record that review in their eQMS and run the installation qualification protocol Greenlight Guru provides. A customer using the eQMS other than as Greenlight Guru intends is responsible for the additional validation.⁹

Seal is the GxP operating system for biopharma, where batch, laboratory and quality records have to stay connected. For a combination product, the finished product is the common parent of its drug or biologic lots, its device revision and components, its assembly, testing and release, so a complaint or change is traced once across both constituents. In Seal, the URS, FS, DS and configuration specification are kept in the platform; when a changeset is prepared for review, its selected user acceptance tests run, and publication requires current passing results for the required tests. Earlier runs keep the version they used. The regulatory guide sets out the approach.

5Where Greenlight Guru is the better fit.

Greenlight Guru is the better fit for medical device companies that want a system built only for medtech, from first design to post-market.

• You make medical devices and want design controls, ISO 14971 risk management and a generated design and development file in a product built for medtech.⁵⁶
• You develop software as a medical device and want design controls linked to Jira and GitHub, with software release traceability.⁴¹⁰
• You run device clinical studies and want electronic data capture, ePRO and post-market clinical follow-up from the same vendor as your QMS.⁴
• You want AI features from a vendor certified to ISO/IEC 42001 for AI governance.¹
• You want to query your eQMS from approved AI assistants through an MCP server.¹⁰
• You prefer a vendor validation package refreshed at each product update, with your team reviewing intended use.⁹

6Where Seal is the better fit.

Seal is the better fit when device work sits beside biopharma manufacturing, laboratory testing and quality, or when design changes must reach what was built.

• You make drug products, biologics or combination products, or your device work shares batch, laboratory and quality records with GMP manufacturing.
• You want each unit linked to its actual build, so a design change or a field report reaches the serials and lots it affects.
• 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 that prepares the linked work. Neil assembles the records a change reaches, finds requirements without verification and configures intake and review workflows from your procedures. It 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 Greenlight Guru.

You do not need to replace Greenlight Guru to start. Seal’s Greenlight Guru connection is set up per project on Greenlight Guru’s REST API. Select the objects and operations included in your subscription, with separate approval for any write-back. In scope are the design controls, documents, parts, suppliers, quality events and training records exposed by the purchased API scope.

Once API access and mappings are configured, Neil can:

• compare design-control records with supplied verification evidence and list unresolved links;
• group selected complaints and compare them with related CAPAs and product context;
• assemble affected parts, supplier records and quality events to assess a supplier change.

On its side, Greenlight Guru’s API is REST with JSON, with keys generated in a developer interface, and supports export, import, update and event notifications. Greenlight Guru notes that an integration your team builds is your software and falls under your own validation.¹⁰ Each connection’s scope also records which system stays the source of truth: Greenlight Guru can remain the design history while manufacturing and its quality records run in Seal.

8Moving from Greenlight Guru to Seal.

Start with one device and one real change, and keep Greenlight Guru for the rest until you decide otherwise.

1. Choose a change with consequences beyond one document, such as a component revision that reaches verification, risk controls and units already built.
2. Bring the affected requirements, the configuration and the available design and verification evidence. Start with sample material, or arrange an NDA before sharing confidential records.
3. Neil proposes the trace structure and the change workflow, and engineering and quality check them against the device. 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. Read the design controls and test evidence from Greenlight Guru through its API, and follow the change into manufacturing and the affected units.
5. Exercise missing verification, an obsolete test version and an affected serial range, then agree which records move and which stay retrievable in Greenlight Guru. Representative records are reconciled and retrieval verified before you rely on the new workflow.

Retention obligations continue for the records that stay in Greenlight Guru. The medical device blueprint describes the design, manufacturing and quality workflows in detail.