Skip to main content

Arena QMS manages quality around the product record. Seal runs each unit’s build on the same records.

Seal, the GxP execution system, is your eBR, your QMS and more. Neil, your AI agent, does the paperwork across your systems. You sign. Paradromics cut operator paperwork by 80%. Start with one process beside Arena QMS.

Book a demo

Where Arena QMS falls short.

From Arena’s and PTC’s own pages and Arena’s reviewers on G2.

  • 2000
    Bom.com, bills of materials
    2016
    QMS, linked to the BOM
    The build
    A separate MES

    A parts list at the centre.

    Arena began in 2000 as Bom.com, managing bills of materials, and its 2016 QMS links quality “directly to the product BOM”. The build runs in a separate MES. In Seal, the build and quality are one set of records.

    Arena, Innovation Timeline
  • Automations
    25 at most
    Workspaces
    5 at most
    Validation
    Additional fees
    Seal
    Neil, then your approval

    Configuration capped by the plan.

    Arena’s QMS plan caps automations at 25 and workspaces at five, and validation carries additional fees. In Seal, Neil configures the first process from your procedure, and your team approves it.

    Arena, Plans and Pricing
  • A G2 reviewer
    “requires you to know the exact name”
    Another
    “feels somewhat dated”

    Hard to search.

    G2’s summary of Arena’s reviews says search can be “challenging, requiring exact terms to find documents”.

    G2, October 2026
  • AI Assistant
    Answers questions
    AI Engine
    Compares documents
    Neil
    Drafts the change

    Its AI reads. Neil does the paperwork.

    Arena’s AI Assistant answers users’ questions, and its AI Engine automates document review and comparison. Neil prepares the change itself and the paperwork around it, for your team to approve.

    PTC, December 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

Arena QMS and Seal, side by side.

Every source is listed under References.

Arena QMSSeal
What it isProduct-centric QMS with PLM, begun as Bom.com in 2000¹²The GxP execution system, with a device QMS built in
Designed forMedical device and high-tech makers³Devices, diagnostics, drugs, biologics
Data modelThe product record: items, BOMs, drawings and documents⁴Primitives your team composes: record types, their relationships, steps and checks
AIHelp answers, document comparison and summaries, item redlines⁵⁶Neil, Seal’s AI agent, prepares changes to the process; your team approves them
Configuring itAutomations and workflows capped by plan⁵Your team, with Neil preparing it from your procedures
Supplier qualityEnterprise QMS plan⁵Part of the QMS
Device recordsDMR and DHF with the BOM¹Design file and each serial as built
ManufacturingA separate MES it connects to⁷Runs the build on the floor
A component issueTicket or CAPA on the part⁸Traced to the serials that used it
ComplaintsA quality process on the product record, with help desk integration⁴⁵Linked to the unit’s build record
LaboratoryNot on its product list¹LIMS and ELN on the same records

Summary

The story
Arena QMS is good for product-centric quality in high-tech and medical device companies.³ Arena was founded in 2000 as Bom.com, whose first product managed bills of materials in the cloud, and added a QMS in 2016 that links quality and change to the product’s bill of materials;² PTC bought it in 2021.⁹ Its model is still the product record of parts, bills of materials, drawings and documents.⁴ Arena says its configurable solutions eliminate “costly coding”,¹ yet its QMS plan caps automations at 25 and workspaces at five, with validation charged on top.⁵ Its AI, from 2025, answers questions from Arena’s help materials and compares and summarises documents.¹⁰⁶ If quality follows the parts list of a product you design, it can work well. Most life sciences teams need quality to follow the process, the batch and the test.

1What Arena QMS offers.

Arena, now Arena by PTC after PTC acquired Arena Solutions in January 2021, is a cloud-native PLM and QMS provider for medical device, high-tech and other hardware companies.¹¹⁹¹² It began in 2000 as Bom.com, selling bill-of-materials management, and released its QMS in 2016.² Arena QMS documents and tracks device master records, design history files, training records and CAPAs in the context of the product record and bill of materials.¹ Its quality processes connect to parts, BOMs, drawings and documents, with complaints handled there and help desk integration available.⁴⁵ Engineering change requests and orders run with automated approvals,¹³ and Arena Tickets track issues linked to affected product records.⁸

PTC launched the Arena AI Assistant in September 2025, which answers questions from Arena’s help materials, and the Arena AI Engine in December 2025, which automates document review and comparison.¹⁰⁶ Its plans list AI help, search, file comparison, file summaries and item redlines.⁵ On G2, 370 of its reviewers file it under product lifecycle management, 227 under quality management and 179 under medical QMS.¹⁴

2Running Seal alongside Arena QMS.

Device teams usually start with the build: Arena keeps the BOM and engineering changes while manufacturing execution and quality move to Seal. No dedicated Arena connector exists on Seal’s integrations list. Seal’s REST API and Scripts are the general route, and Seal can review Arena’s interfaces with you. On Arena’s side, the Developer Platform provides a RESTful API and webhooks.⁷

Arena’s webhooks and outbound event integrations can send data to a target system, which can write to Seal through Seal’s API; or a Seal Script, versioned Python run after an event or on a schedule, can call Arena’s API.⁷ Either way, agree credentials, direction and failure handling first, and treat Scripts like any configuration: changed and tested. Each interface needs more than a field map: object identity, which system is authoritative, acknowledgement, duplicate handling, behaviour during an outage and reconciliation. That design is part of validation, because it decides which system a reviewer trusts when values disagree or messages arrive late. Start by reading the released revision and BOM, and treat any write-back to Arena as a separate decision; the regulatory guide sets out the checks.

3Moving from Arena QMS to Seal.

Move one device at a time. Design controls, quality and the build run in Seal, and Arena can keep the BOM and engineering changes for as long as you need it.

  1. Choose one representative device and run it from component receipt through serial assignment, assembly, inspection, a failed check, approved rework, UDI labelling, review and release.
  2. Bring the released BOM revision, routing, work instructions, inspection plan, label templates and a recent traveler. Sample material works for a first look, and an NDA covers anything confidential.
  3. Neil proposes the device configuration, the guided steps and their review states from that material. Once the scope is agreed and the inputs received, Seal prepares the first working process and its supporting validation pack to evaluate within 48 hours; production release follows your intended-use assessment and quality controls.
  4. Trace backward from the released serial and forward from a component lot, then rehearse a calibration failure, incorrect firmware, a label reprint, missing supplier evidence and a field complaint.
  5. Agree which records move and which stay retrievable in Arena. Design history files and device master records can remain there, and representative records are reconciled before you rely on the new workflow.

Retention obligations continue for the records that stay in Arena. The eDHR and medical device blueprints show the workflows in detail.

References

  1. 1Quality Management System, Arena. https://www.arenasolutions.com/platform/qms/ (read 5 November 2026)
  2. 2Over Twenty-Five Years of Cloud PLM and QMS Innovation, Arena. https://www.arenasolutions.com/about/innovation-timeline/ (read 5 November 2026)
  3. 3A Single Cloud Platform for PLM and QMS, Arena. https://www.arenasolutions.com/platform/ (read 5 November 2026)
  4. 4Ensure Product Quality With Connected Quality Management, Arena. https://www.arenasolutions.com/solutions/quality-management/ (read 5 November 2026)
  5. 5Arena Plans and Pricing, Arena. https://www.arenasolutions.com/pricing-plans/ (read 5 November 2026)
  6. 6PTC Launches Arena AI Engine to Accelerate Intelligent Automation Across PLM and QMS Workflows, PTC, 9 December 2025. https://www.ptc.com/en/news/2025/ptc-launches-arena-ai-engine (read 5 November 2026)
  7. 7Arena Developer Platform, Arena. https://www.arenasolutions.com/resources/arena-developer-platform/ (read 5 November 2026)
  8. 8Issue Management, Arena. https://www.arenasolutions.com/solutions/issue-management/ (read 5 November 2026)
  9. 9PTC Completes Acquisition of Arena Solutions, PTC, 19 January 2021. https://www.ptc.com/en/news/2021/ptc-completes-acquisition-arena-solutions (read 5 November 2026)
  10. 10PTC Launches Arena AI Assistant to Accelerate PLM and QMS Workflows, PTC, 16 September 2025. https://www.ptc.com/en/news/2025/ptc-launches-arena-ai-assistant (read 5 November 2026)
  11. 11About Arena, Arena. https://www.arenasolutions.com/about/ (read 5 November 2026)
  12. 12Biotechnology, Arena. https://www.arenasolutions.com/industries/biotechnology/ (read 5 November 2026)
  13. 13Engineering Change Management, Arena. https://www.arenasolutions.com/solutions/engineering-change-management/ (read 5 November 2026)
  14. 14Arena PLM & QMS reviews, G2, as archived on 12 October 2026. https://web.archive.org/web/20261012114912/https://www.g2.com/products/arena-plm-qms/reviews (read 5 November 2026)

AQuestions and answers

Is Seal better than Arena QMS?

Yes. Arena QMS is good for product-centric quality in high-tech and medical device companies. Arena was founded in 2000 as Bom.com, whose first product managed bills of materials in the cloud, and added a QMS in 2016 that links quality and change to the product’s bill of materials; PTC bought it in 2021. Its model is still the product record of parts, bills of materials, drawings and documents. Arena says its configurable solutions eliminate “costly coding”, yet its QMS plan caps automations at 25 and workspaces at five, with validation charged on top. Its AI, from 2025, answers questions from Arena’s help materials and compares and summarises documents. If quality follows the parts list of a product you design, it can work well. Most life sciences teams need quality to follow the process, the batch and the 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 and legacy systems, Paradromics cut operator paperwork by 80% and engineers’ traveler review time by 90%.

Is Seal an alternative to Arena QMS?

Yes. Arena QMS is designed for product-centric quality, tied to the BOM. Seal is a complete device QMS, with design controls, ISO 14971 risk, CAPA, complaints, documents and training, and it also runs the build and keeps each unit’s record as built, so a change or complaint reaches the serials affected. Arena can keep the BOM and engineering changes while the build and quality run in Seal.

Is Seal a medical device QMS?

Yes. Seal covers design controls, ISO 14971 risk management, CAPA, nonconformances, complaints, document control, training, suppliers, audits and device history records. Paradromics and Bioventix run their quality systems on Seal, and the same platform runs laboratory and batch work for drugs, biologics and combination products.

Is Arena QMS a PLM or a QMS?

One platform, sold as separate PLM and QMS plans: Arena’s quality processes attach to items, BOMs and engineering changes in Arena PLM, and its QMS plan caps automations, workspaces and integration workflows. Seal is a complete QMS that also runs the build, the laboratory and batch work, configured from your procedures, so quality reaches each unit, lot and sample.

Can Seal work alongside Arena?

Yes. Seal has no dedicated Arena connector, but Arena’s Developer Platform offers a RESTful API and webhooks, and Seal’s REST API and Scripts can connect the two, starting with read access to the released revision and BOM.

Does Arena QMS run manufacturing?

Arena QMS is designed for product-centric quality: it keeps the product record as designed, and manufacturing execution is a separate MES that Arena connects to. In Seal, the approved configuration runs on the floor, and each serial’s record shows the revision, components, firmware and inspections it was made with.

How does Arena’s AI compare with Neil?

PTC launched the Arena AI Assistant in September 2025, which answers questions from Arena’s help materials, and the Arena AI Engine in December 2025, which automates document review and comparison. Neil prepares changes to the process itself, with their tests, for your approval, and each change is released as a new version. Neil is not used in GMP execution.

How long does it take to start with Seal?

For one representative device, Seal prepares a first working process, configured from your device master data and procedures, and its supporting validation pack to evaluate within 48 hours of agreeing the scope and receiving the inputs. Production timing then depends on scope, interfaces, migration and your release requirements.

Start beside Arena QMS.

Start with one device. Seal’s REST API and Scripts read the released revision and BOM from Arena, so nothing has to move on day one.

Book a demo