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IQVIA SmartSolve keeps quality and regulatory records. Seal runs the work they record.

Seal, the GxP execution system, is your eBR, your QMS and more. Neil, your AI agent, does the paperwork across your systems. You sign. Skye Biologics cut non-⁠conformances by 40%. Start with one process beside IQVIA SmartSolve.

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Where IQVIA SmartSolve falls short.

From IQVIA’s own pages, fact sheets and case study.

  • SmartSolve, first value
    “within a few months”
    Seal, a first process
    48 hours

    Months to go live.

    IQVIA says many organisations begin seeing value from SmartSolve within a few months, in phases. Seal has a first process working for you to evaluate within 48 hours, once the scope is agreed and the inputs received.

    IQVIA, SmartSolve eQMS
  • Design and configuration
    IQVIA’s services
    Validation and go-live
    IQVIA’s services
    Seal
    Neil, then your approval

    Configured by a services team.

    IQVIA sells solution design and configuration, integration and data migration, and testing, validation and go-live support as professional services. In Seal, Neil configures the first process from your procedure, and your team approves it.

    IQVIA, October 2022
  • First phase
    Documents and training
    Under way
    Change management
    Still planned
    Deviations and CAPA

    One module at a time.

    In IQVIA’s 2026 case study, Anemocyte began with documents and training; change management followed, with deviations and CAPA still planned. In Seal, deviations, CAPA, documents and training are one set of records.

    IQVIA, May 2026
  • LIMS
    Via SmartSolve APIs
    MES
    Via SmartSolve APIs
    Seal
    One set of records

    The lab and the plant, through APIs.

    IQVIA connects SmartSolve to LIMS, MES and ERP systems through SmartSolve APIs, so a deviation reaches its batch through an interface. In Seal, the lab, the batch and quality are one set of records.

    IQVIA, December 2025
  • SmartSolve AI
    Drafts summaries
    Also
    Draws on precedent
    Neil
    Drafts the change

    Its AI summarises. Neil does the paperwork.

    IQVIA says SmartSolve’s AI drafts summaries and draws on precedent information. Neil prepares the change itself and the paperwork around it, for your team to approve.

    IQVIA, November 2025

See it in Seal.

Real Seal screens with fictional test data: one late transfer, from the batch record to the fix, then Neil’s overnight release review.

  1. 1

    Each value at the step it belongs to.

    Batch B-041’s readings are recorded as the work happens, with its sample and its deviation linked to the record.

    Batch record B-041, post-mix hold and transfer, in Seal: the instruction to transfer within 45 minutes of completing the mix, process readings at 10:12, 10:42 and 11:04 with temperature and pH, and the linked lab sample IPC-041 and investigation DEV-018.
    1. The step’s limitTransfer within 45 minutes of completing the mix.
    2. Recorded as it happensMix complete at 10:12, transfer at 11:04: 52 minutes.
    3. The deviation, linkedDEV-018 sits on the batch record it concerns.
  2. 2

    The deviation starts with its evidence.

    DEV-018 has the batch, its readings and the sample linked, so the investigation starts from the facts.

    Deviation DEV-018, extended post-mix hold, in Seal: the affected batch B-041, the transfer 52 minutes after mixing against a permitted 45, and a table of evidence from the process readings, temperature readings and sample IPC-041.
    1. The batchB-041, the batch the deviation concerns.
    2. What happened52 minutes, against a permitted 45.
    3. The evidenceReadings and the sample, from the same records.
  3. 3

    The fix is a change to the workflow.

    CC-019 makes the record calculate the hold and route anything over 45 minutes. It is verified before release, and the next batch runs the new version.

    Change CC-019, elapsed-time check, in Seal: DEV-018 as the reason, the affected procedure MBR-014, a table of current and proposed workflow behaviour, a verification plan at 44, 45 and 46 minutes and a missing start time, and a release review for authorised people.
    1. From the deviationDEV-018 is the reason for the change.
    2. The workflow itselfThe hold is calculated from both timestamps, and anything over the limit is routed for assessment.
    3. Verified before releaseAt 44, 45 and 46 minutes, and with a start time missing.
  4. 4

    Neil checks every lot. People decide.

    Overnight, Neil checked each lot against its release plan and said what its record leaves out.

    The release board in Seal: 111 lots in release across three sites, $123M waiting, 86 with nothing open, and a table of the lots with findings, each with Neil’s summary, its value and a predicted certification date.
    1. The morning, in two lines111 lots and $123M waiting. 86 need only a decision.
    2. Neil’s summary of each lotWhat is open, and where Neil found it.
    3. A predicted certification dateFrom how long this site’s lots have taken.

What Seal’s customers measured.

Each figure links to the customer’s story.

QualityAcclinate and Skye Biologics

−50%
quality cycle times at Acclinate, from a procedure change to everyone trained.Acclinate
−40%
non-conformances at Skye Biologics, with training checked before execution.Skye Biologics

RecordsMiAlgae and Bioventix

−75%
documentation time at MiAlgae, from the lab to commercial production.MiAlgae
−80%
document admin time at Bioventix, after two decades on paper.Bioventix

IQVIA SmartSolve and Seal, side by side.

Every source is listed under References.

IQVIA SmartSolveSeal
What it iseQMS for life sciences¹The GxP execution system, with QMS built in
Built forPharma, IVD and medical devices¹Devices, diagnostics, drugs, biologics
Data modelQuality modules, from documents to CAPA²Primitives your team composes: record types, their relationships, steps and checks
AIProblem codes, summaries and trends on quality records³²Neil, Seal’s AI agent, prepares changes to the process; your team approves them
Laboratory and plantSeparate LIMS and MES, via APIs⁴LIMS, ELN and batch records built in
Configuring itIQVIA professional services, as in its 2026 case study⁵⁶Your team, with Neil preparing it
Quality eventsTriage by decision tree⁴Linked to the batch and result
Regulatory informationSmartSolve RIM, a second product on the platform⁷Registrations on the same records
Getting startedPhased; value within a few months¹A 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
IQVIA SmartSolve is good for quality and regulatory record-keeping in life sciences.¹ It began at Pilgrim Software, co-founded in 1994, which built an on-premises quality application to replace spreadsheets and notebooks;⁸ by 2007 Pilgrim sold SmartSolve as modules for documents, CAPA and complaints, audits and training,⁹ and in 2017 IQVIA bought the company.¹⁰¹¹ IQVIA says its workflows are configurable,¹ yet it sells solution design, configuration, validation and go-live support as professional services, and says many organisations begin seeing value within a few months, in phases.⁵¹ Its AI, recognised in 2024 for recommending problem codes for device adverse-event reports, now also drafts summaries and draws on precedent information.³² If quality can run apart from the laboratory and the plant, it can work well. That is rare once a deviation has to be read with its batch and its test.

1What IQVIA SmartSolve offers.

SmartSolve began as Pilgrim Software’s quality system: in 2007 Pilgrim, based in Tampa, sold SmartSolve for documentation, CAPA and complaint handling, auditing and training.⁹ Riverside Partners bought Pilgrim in 2011 and sold it in 2017,¹⁰ to IQVIA.¹¹ IQVIA now describes SmartSolve eQMS as a cloud-based enterprise QMS on Microsoft Azure, designed for pharmaceutical, in vitro diagnostics and medical device companies,¹ with modules from document, training and change management to CAPA, deviations, complaints, risk, design control and supplier quality.²¹² Its quality event management triages each reported event with a questionnaire and a configurable decision tree.⁴ IQVIA says SmartSolve uses AI to identify risks, detect trends and automate routine quality workflows,¹ and its fact sheet adds AI that drafts summaries and draws on precedent information.²

2Running Seal alongside IQVIA SmartSolve.

Teams usually move to Seal one process at a time. IQVIA describes integrating SmartSolve with other systems through SmartSolve APIs,⁴ and Seal’s REST API and Scripts connect to them; Seal reviews the interfaces with you.

A Seal Script can call SmartSolve’s APIs after an event or on a schedule, and Scripts are versioned and are changed and tested like other records before publication. A common first step reads registrations and approved market states from SmartSolve RIM while the market assessments and implementation gates for one change run in Seal. Start with read access, decide any write-back separately, and qualify the connection with the identifier, mapping and reconciliation checks in the regulatory guide.

3Moving from IQVIA SmartSolve to Seal.

Start with one process that has to reach the work.

  1. Choose one recent multi-market change, or another process where a quality decision must reach the batch, such as batch release.
  2. Bring the change record, the affected registrations and commitments, and the procedure. Start with sample records, or 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. Once the scope is agreed and the inputs received, Seal prepares the first working process and its validation pack to evaluate within 48 hours. Production timing then depends on scope, interfaces, migration and your release requirements.
  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. Relationships, attachments, versions and available audit context are preserved within that scope, 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.

References

  1. 1SmartSolve eQMS for Life Sciences, IQVIA. https://www.iqvia.com/solutions/safety-regulatory-compliance/quality-compliance/smartsolve-eqms (read 5 November 2026)
  2. 2SmartSolve eQMS fact sheet, IQVIA, November 2025. https://www.iqvia.com/-/media/iqvia/pdfs/library/fact-sheets/2025/smartsolve-eqms-fact-sheet.pdf (read 5 November 2026)
  3. 3IQVIA’s SmartSolve eQMS Wins 2024 MedTech Breakthrough Award “Best Use of Artificial Intelligence in Healthcare”, IQVIA, 25 June 2024. https://www.iqvia.com/newsroom/2024/06/iqvias-smartsolve-eqms-wins-2024-medtech-breakthrough-award (read 5 November 2026)
  4. 4SmartSolve Quality Event Management fact sheet, IQVIA, December 2025. https://www.iqvia.com/-/media/iqvia/pdfs/library/fact-sheets/2025/smartsolve-event-management.pdf (read 5 November 2026)
  5. 5IQVIA SmartSolve eQMS fact sheet, IQVIA, October 2022. https://www.iqvia.com/-/media/iqvia/pdfs/us/fact-sheet/smartsolve-eqms-iqvia-fact-sheet.pdf (read 5 November 2026)
  6. 6Transforming Quality Operations at Anemocyte with IQVIA SmartSolve eQMS, IQVIA, May 2026. https://www.iqvia.com/-/media/iqvia/pdfs/library/case-studies/2026/transforming-quality-operations-at-anemocyte-with-iqvia-smartsolve-eqms.pdf (read 5 November 2026)
  7. 7IQVIA SmartSolve RIM, IQVIA. https://www.iqvia.com/solutions/safety-regulatory-compliance/regulatory-compliance/smartsolve-rim (read 5 November 2026)
  8. 8The Platform Chronicles: 10 Questions with Prashanth Rajendran, CEO, ComplianceQuest, AppExchange and the Salesforce Ecosystem (Salesforce, on Medium), 23 March 2022, as archived on 17 September 2022. https://web.archive.org/web/20220917220036/https://medium.com/inside-the-salesforce-ecosystem/platform-chronicles-10-questions-ceo-compliancequest-6904f597286a (read 5 November 2026)
  9. 9Avecia Biotechnology Inc. Chooses Pilgrim Software's SmartSolve(R) Solution, Pilgrim Software (Business Wire release reproduced by BioSpace). https://www.biospace.com/avecia-biotechnology-inc-chooses-pilgrim-software-s-smartsolve-r-solution (read 5 November 2026)
  10. 10Riverside Partners Sells Pilgrim Quality Solutions to Strategic Acquirer, Riverside Partners (press release reproduced by Training Industry), 16 October 2017. https://trainingindustry.com/press-release/compliance/riverside-partners-sells-pilgrim-quality-solutions-to-strategic-acquirer/ (read 5 November 2026)
  11. 11Fusion 2018: Pilgrim Quality, IQVIA, and Next-Generation Quality, LNS Research. https://blog.lnsresearch.com/fusion-2018-pilgrim-quality-iqvia-and-next-generation-quality-mondaymusings (read 5 November 2026)
  12. 12SmartSolve eQMS for Pharma, IQVIA. https://www.iqvia.com/solutions/safety-regulatory-compliance/quality-compliance/smartsolve-eqms/smartsolve-eqms-for-pharma (read 5 November 2026)

AQuestions and answers

Is Seal better than IQVIA SmartSolve?

Yes. IQVIA SmartSolve is good for quality and regulatory record-keeping in life sciences. It began at Pilgrim Software, co-founded in 1994, which built an on-premises quality application to replace spreadsheets and notebooks; by 2007 Pilgrim sold SmartSolve as modules for documents, CAPA and complaints, audits and training, and in 2017 IQVIA bought the company. IQVIA says its workflows are configurable, yet it sells solution design, configuration, validation and go-live support as professional services, and says many organisations begin seeing value within a few months, in phases. Its AI, recognised in 2024 for recommending problem codes for device adverse-event reports, now also drafts summaries and draws on precedent information. If quality can run apart from the laboratory and the plant, it can work well. That is rare once a deviation has to be read with its batch and its test. Seal has no fixed model of one kind of work. It is built from primitives: record types, the relationships between them, and the steps and checks that use them, which your own team composes into your process, with Neil able to prepare each change for approval. So one platform runs process development, the laboratory, manufacturing, batch release and the quality system, and each change becomes a new version, released once its selected tests pass, while earlier runs keep theirs. Moving from paper, Skye Biologics cut non-conformances by 40%, with training checked before execution.

Is IQVIA SmartSolve the same as Pilgrim SmartSolve?

Yes. SmartSolve was developed by Pilgrim Software, later Pilgrim Quality Solutions, which IQVIA acquired in 2017. IQVIA now sells it as SmartSolve eQMS.

Is Seal an alternative to IQVIA SmartSolve?

Yes. SmartSolve is designed for life sciences quality management. Seal covers the quality processes SmartSolve manages, including deviations, CAPA, change, complaints, documents, training, audits and suppliers, and regulatory change by market. It also runs the laboratory and manufacturing, so a corrective action or a market’s implementation decision reaches the batches it concerns.

Can Seal work alongside IQVIA SmartSolve?

Yes. SmartSolve offers APIs, and Seal’s REST API and Scripts connect to them, starting with read access. Teams usually move one change or process to Seal first while the rest stays in SmartSolve.

Does SmartSolve run the laboratory or manufacturing?

SmartSolve is designed for life sciences quality management, and IQVIA describes connecting it to LIMS, MES and ERP systems through SmartSolve APIs. In Seal, the laboratory, the electronic lab notebook and electronic batch records run on the same records as the quality system, so a corrective action or a market’s implementation decision reaches the batches it concerns.

How does SmartSolve’s AI compare with Neil?

IQVIA says SmartSolve’s AI recommends problem codes for medical device adverse event reports, drafts summaries, draws on precedent information, identifies risks and trends, and automates routine quality workflows: it works on the quality records SmartSolve holds. Neil prepares changes to the process itself: it configures the workflow from your procedure and drafts each change with its verification cases, and your team approves and releases it. In line with the EU’s draft GMP Annex 22 on AI, Neil is not used in GMP execution.

How long does it take to start with Seal compared with SmartSolve?

Once the scope is agreed and the inputs received, Seal prepares a first working process and its validation pack to evaluate within 48 hours, configured from your procedures, and further processes are added the same way. IQVIA describes a phased SmartSolve implementation in which many organisations begin seeing value within a few months. Production timing in Seal then depends on scope, interfaces, migration and your release requirements.

Start beside IQVIA SmartSolve.

Start with one multi-market change or one process. Seal’s REST API and Scripts read from SmartSolve’s APIs, so nothing has to move on day one.

Book a demo