Seal vs IQVIA SmartSolve

1IQVIA SmartSolve and Seal, side by side.

SmartSolve and Seal both reach past the quality department, in different directions. IQVIA describes SmartSolve as one platform for quality, regulatory and safety processes across the product lifecycle, and its regulatory information management product, SmartSolve RIM, runs on the same platform with a common data structure.¹² Seal reaches into the work: teams configure laboratory, manufacturing and quality workflows on one platform around a shared ontology, so a change, the batches made under it and the decisions about them are connected records.

2What IQVIA SmartSolve is built for.

SmartSolve is built for pharmaceutical, diagnostics and medical device companies that want quality and regulatory compliance on one enterprise platform, from a company whose wider business serves life sciences. It began as Pilgrim SmartSolve: IQVIA acquired its developer, Pilgrim Quality Solutions, then based in Tampa, Florida.³ IQVIA now describes SmartSolve eQMS as a cloud-based enterprise QMS on Microsoft Azure, purpose-built for pharmaceutical, in vitro diagnostics and medical device companies and distinct from other products that use the SmartSolve name, and says more than 1.29 million people use it.⁴ SmartSolve Fundamentals is a ready-to-use cloud QMS for smaller pharmaceutical and medtech teams, covering CAPA, deviations or events, documents and change.⁵

For pharmaceutical companies, IQVIA lists training, change, CAPA, deviation, nonconformance, audit, quality event and risk management, quality intelligence, asset management, design control, a quality portal, complaint management, a regulatory connector, post-market surveillance, document management, and supplier quality and inspection management.⁶ Its quality event management lets anyone report an event without first choosing a process; a questionnaire and a configurable decision tree then triage it, which can create deviation or CAPA records, route it for investigation or close it, and Quality Intelligence runs on Microsoft Power BI.⁷

IQVIA’s fact sheet describes AI that drafts summaries, draws on precedent information and improves consistency.¹ IQVIA has also described machine learning and natural language processing that read adverse event descriptions, identify and classify reports, and present them for qualified human review.⁸ For packaging, IQVIA Proof compares approved artwork with printed output and, used with SmartSolve, records the results with audit trails and electronic signatures.⁶

3How a change reaches each market and the work.

Both products link a change to the regulatory work it needs. SmartSolve joins the quality and regulatory records on one platform; Seal joins each market’s decision to the work that makes product for that market.

SmartSolve RIM centralises product registrations, submission and publishing, and correspondence and commitments with health authorities. It manages change plans, from simple document updates to multi-step initiatives involving new products, suppliers or regulatory requirements, with their actions, timelines and supporting evidence. IQVIA has re-platformed RIM on Microsoft Azure to unify it with the eQMS on a common data structure, and says it connects with more than 20 quality and regulatory modules.² The eQMS fact sheet lists regulatory impact assessment among its capabilities.¹

In Seal, a change is not complete until each market can use it. In the example in Seal’s regulatory change impact blueprint, change CMC-CHG-014 adds a second drug-product site. Seal follows recorded relationships from the changed site to products, registrations, dossiers, labels and commitments and proposes the affected markets, which regulatory owners confirm, add to or exclude with a rationale. The one technical change then follows four market pathways, each with its own implementation gate: the US gate is blocked until prior approval, the EU gate is locked pending an authority response, and the Canadian gate is open for lots made after 1 October 2026.

Because the gate sits with the work, execution, ERP, labelling, release and distribution controls can use the applicable decision, and a batch can be eligible for one market and not another. The change closes only when quality and regulatory records agree, and deferred markets stay visible with owners and conditions. Seal’s blueprint is explicit that this is not a second RIM system or an eCTD publisher: the RIM system remains the authoritative portfolio of registrations, submissions, correspondence and approved market states. Neil can propose the affected products and markets and extract candidate commitments from correspondence, but it does not approve a classification or authorise implementation.

To test either approach, take one recent multi-market change and ask what stops a lot made under the new state from being released for a market that has not yet approved it.

4Generated test scripts and tests that run with each change.

Both vendors automate validation evidence. SmartSolve generates and runs performance qualification scripts from the configured workflows; Seal runs the acceptance tests selected for each changeset before it can be published.

IQVIA’s patented Automated Validation starts from business requirements defined as visual workflows, forms, roles and policies. Its engine analyses the workflows, compiles their paths and derives use cases as executable PQ scripts, which an automation platform runs by emulating user interactions, producing screenshots, video recordings and a traceability matrix. Under the managed service, PQ scripts are created during the first release and run through Automated Validation, and IQVIA reviews the release notes for each upgrade; Extended Validation Services add an assigned validation manager and deliverables such as the validation plan, trace matrix, deviation report and summary report. IQVIA says this shortens SmartSolve validation from weeks to days, in line with GAMP 5.⁹

In Seal, rules across the governed scope decide which acceptance tests a change selects, and they run in a background simulation when the changeset is prepared for review. Publication requires current passing results for the required tests, and failures and retests stay part of the release review. The rules matter: a change that matches no test rule can have no automated coverage, so the risk assessment decides whether a change also needs new scenarios or more human testing. Requirements, specifications and configuration stay linked to the released version, and earlier work keeps the version it used.

5Where IQVIA SmartSolve is the better fit.

SmartSolve is the better fit when you want quality and regulatory information management from one vendor, on one platform, at enterprise scale.

• You want your eQMS and RIM on a common data structure, with registrations, publishing and health authority correspondence beside quality.²
• You handle complaints and post-market surveillance at volume and want AI that classifies adverse event reports for human review.⁶⁸
• You want the vendor to author and run validation scripts for each release, with a validation manager if needed.⁹
• You make pharmaceuticals, diagnostics and medical devices and want one eQMS across them.⁴
• You want packaging artwork verification recorded in the quality system through IQVIA Proof.⁶

6Where Seal is the better fit.

Seal is the better fit when regulatory and quality decisions have to govern the work itself, across laboratory and manufacturing.

• You want the laboratory and the plant on the same records as quality, so a result, its sample and its batch are linked rather than copied between systems.
• You want each market’s implementation decision available where the work runs, so execution, release and distribution can act on it, with deferred markets kept visible.
• You want the fix for a deviation to be a new version of the workflow, verified before release and judged on the batches that follow.
• You want every configured change to carry its specifications, test evidence and approvals, with earlier runs keeping the version they used.
• You want Neil to prepare the work: the affected products and markets, the investigation evidence and the changeset with its verification cases. Neil works within the permissions of the person asking and does not release a change itself. 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 IQVIA SmartSolve.

SmartSolve is not on Seal’s integrations list, so there is no dedicated connector; Seal’s REST API and Scripts are the route, and Seal can review the interfaces with you. On its side, IQVIA describes integrating SmartSolve with CRM, ERP, LIMS, MES and PLM systems through SmartSolve APIs.⁷

An integration can write to Seal through Seal’s API, or a Seal Script can call SmartSolve’s APIs after an event or on a schedule. Agree credentials, direction and failure handling first; Scripts are versioned and pass through a changeset and testing before publication. A natural division keeps SmartSolve RIM as the authority for registrations and approved market states, and SmartSolve as the record for documents and training, while the market assessments and implementation gates for one change run in Seal and read the registration records they need. Start with read access, decide any write-back separately, and qualify the connection with the identifier, mapping and reconciliation checks in the regulatory guide.

8Moving from IQVIA SmartSolve to Seal.

Move one process first; SmartSolve stays the record for everything else.

1. Choose one recent multi-market change, or another process where a quality decision must reach the work, such as batch release.
2. Bring the change record, the affected registrations and commitments, and the procedure. Sample records are enough for a first look; arrange an NDA before sharing real ones.
3. Neil proposes the workflow: the impact set, the market assessments, the implementation gates and the closure policy. With the scope agreed and the inputs received, the first working process and its supporting validation pack follow within 48 hours; production release still follows your intended-use assessment and quality controls.
4. Exercise the hard cases: a market whose approval is still pending, a lot made before the effective date, and a requirement updated after an assessment was signed.
5. Agree which records move and which stay retrievable in SmartSolve. Within that scope, relationships, attachments, versions and available audit context are preserved, and representative records are reconciled before you rely on the new workflow.

Retention obligations continue for the records that stay in SmartSolve. The regulatory change impact and QMS blueprints show the workflows in detail.