ReviewsScilife

Scilife review

A life-sciences eQMS from Belgium that users find easy to learn, with an included validation package and a design-controls module added in 2025. Pharma is its stronger side, and prices are only available on request.

Price
on requestNo public or buyer-reported prices found
Free trial
Free trial after a callSelf-guided tours; 30-minute demo
EU hosting
EU or USEU for GDPR customers; no public DPA or subprocessor list
Last checked
Oct 2026
Placeholder data: some scores, prices and features on this page have not been verified yet.

What we like

  • Users find it easy to learn: 8.6/10 for ease of use on G2, and reviewers repeatedly call it intuitive.
  • An executed GAMP 5 validation package (IQ, OQ, PQ, traceability matrix) and test, validation and production environments come with every paid plan.
  • Onboarding guidance with a dedicated expert is listed in every paid plan, and support is rated 8.9/10 on G2.
  • Covers pharma GMP and devices in one system, with deviations, equipment qualification and controlled printing alongside design controls.
  • A large public help center (over 700 articles) documents how the workflows actually work.

What to watch

  • No prices are published, now or in archived pages going back to 2021.
  • Design controls only arrived in July 2025, and FMEA risk assessments aren't linked to them.
  • Complaints run through a generic events workflow, with no documented reportability, FDA MDR or EU vigilance steps, UDI or DHR features.
  • No ISO 27001 or SOC 2 certification, public DPA or subprocessor list found.
  • Audits and supplier management require the top tier (Core +).

About the price: No public prices, now or in archived pages back to 2021 (checked Sep 2026). Per-user licences in three tiers (Essential, Core, Core +); onboarding guidance and the validation package are listed in every paid tier.

What is Scilife?

Scilife is a quality management platform built by Scilife NV, a Brussels-based company.1 It began in 2017 as QbD Software, whose eQMS was called QualityKick. The company and product took the Scilife name in 2021.23 Five Elms Capital invested in 2024.4 A US subsidiary has operated since 2023.5 Scilife says it has more than 240 customers and 90 staff.3

It serves life sciences broadly: pharma, biotech, medical devices, logistics and more. Named customers include Novartis and Polpharma.6 Much of the product is built around GMP work, including deviations, equipment qualification and controlled printing.7 A Design and Development module for medical devices launched in July 2025.8

Who Scilife is for

Scilife fits best for pharma, biotech or combined device and pharma companies that want one validated system for documents, training, CAPA, change control and deviations.7 Users praise how quickly people get productive.910

It’s workable for medical device teams, and device startups appear among its customer stories.1112 But the device-specific depth is limited.

Look elsewhere if you:

  • Build software as a medical device. We found no Jira or Git integration, and IEC 62304 support is only a product-page claim.1314
  • Need ISO 14971 risk tied to design. Risk assessments use FMEA only and sit apart from design controls.1516
  • Want templates out of the box. We found no SOP or form library in the product.17

Scilife pricing

Scilife doesn’t publish prices. Its pricing pages list three tiers with “Get pricing” buttons (checked September 2026).7 Archived versions going back to 2021 never showed prices either.1819 Licences are per user, and deactivated users still count.20

For the device edition, the tiers stack like this:7

  • Essential: design and development, documents, training, competences, records and KPIs.
  • Core: adds CAPA, change control and quality events, including complaints.
  • Core +: adds audits, supplier management, risk assessment and equipment.

A device company that needs audits and supplier control therefore needs Core +.

Every paid tier lists onboarding guidance, the validation documentation package, three environments and one-to-one support.7 Scilife says support never costs extra. Additional onboarding services are available at extra cost.6

Capterra’s listing shows a starting price of $1,000 per user per month.21 That figure doesn’t appear on Scilife’s own site and looks implausible for this market, so we don’t use it. We found no buyer-reported prices, so we can’t estimate a 10-person cost. Ask for a written quote per tier.

Features

Scilife publishes a large help center (over 700 articles) and self-guided product tours. We checked features against both.2223

Document control and records

Documents follow configurable review, approval and QA workflows with Part 11 signatures.24 Editing happens in Microsoft Word through “Live Edit”. The document is locked in Scilife while it’s open and versions are saved back automatically.25 Published documents can be downloaded in bulk as a zip file.26 A records module builds forms for other quality records.27

Design controls and risk

The Design and Development module covers user needs, design inputs, outputs, verification, validation and test runs.16 A traceability matrix flags unlinked items. It exports to DOCX, XLSX, PDF or CSV.28 You can import whole projects from Excel.29

To build a design history file, the vendor says you export and compile it yourself.14 Documents link to design items only through hyperlinks.14

Risk is the gap. The risk module supports only FMEA and targets processes, equipment and systems.1530 Risk items don’t exist in the design module.16 Scilife announced built-in risk management for design as upcoming in July 2025.8

CAPA and quality events

Quality events are built from configurable event types.31 The product tour shows deviations, non-conformities and complaints going through investigation, root cause and impact assessment, then linking to CAPA.32 CAPAs support multiple actions, approver and QA sign-off, and effectiveness checks.33 Change requests include impact, tasks, linked risk assessments and effectiveness checks.34

We found no complaint-specific steps such as a reportability decision, no FDA MDR or EU vigilance reporting, and no UDI or device history record features.22 The device industry page mentions “post-market workflows” without detail.35

Training

Training can include documents, links, tasks and assessments with a pass mark.36 Updates trigger retraining automatically.37 An AI beta feature can draft an assessment from a document.38

Supplier management

Supplier qualifications track questionnaires, risk files and QA sign-off. A supplier can be set to “Audit Required” and linked to audits and CAPAs.39 Questionnaires are exchanged outside the system and uploaded.39

What users say

  • G2: 4.3/5 from 76 reviews, with 8.6/10 for ease of use and 8.9/10 for quality of support (checked in a browser on 30 September 2026).40
  • Capterra: 4.4/5 from 13 reviews under the old name QualityKick, mostly written in 2020.9

Recurring themes:

  • Easy to use. At least six Capterra reviewers call it intuitive or easy to use.9 A former user on Reddit called it “one of the most intuitive and qualitative systems”.10
  • Helpful support. Capterra reviewers praise quick ticket handling.9
  • Early bugs. Several 2018–2020 reviewers mention bugs and “teething problems” that were fixed quickly.9
  • Training module. Three reviewers found it weaker than the rest.9

We couldn’t read G2’s review text. Search summaries mention support and bug complaints there, but we couldn’t verify them. Reddit discussion is sparse. One active commenter works for Scilife, so we excluded that account.41

All 76 G2 reviews were read in October 2026: 89% are labelled by G2 as invited by the vendor or incentivized, and 38% of them arrived within a single six-week window.42 Because invited and burst reviews tend to skew positive, our usability, support and sentiment scores are capped at 8 rather than taken at face value.

Security, hosting and validation

Scilife runs in an AWS virtual private cloud. Data is encrypted and each customer gets separate databases, backed up every five minutes.4344 Data sits in a European or US data centre. Customers who need GDPR compliance are hosted in Europe.7 We found no public data processing agreement or subprocessor list.1

The only certification we found is ISO 9001.45 We found no ISO 27001 or SOC 2 claim.

Validation is a strength. Customers receive an executed GAMP 5 package including IQ, OQ, PQ and a traceability matrix.46 An updated package arrives 60 days before each medium or major release, in a separate validation environment.47 Single sign-on works with Microsoft Entra ID.13

Buying and contract terms

  • Trial: a free trial is advertised, but the sign-up form leads to booking a call.48 The website has self-guided product tours, and you can book a 30-minute demo.2317
  • Contract: subscriptions are annual.6 The customer terms leave the first term to the order form and renew the agreement automatically for another year unless you give notice 30 days before it ends.49
  • Leaving: the terms promise a one-time transfer of all your data at no extra charge, in a commonly accepted file format; further exports cost extra.49 Any list exports to XLS or CSV.7 Documents download in bulk.26 Read-only database access and a REST API are available, but the API documentation isn’t public.136
  • Price increases: the terms let Scilife change its fees once a year, with written notice at least 60 days before the term ends. There’s no cap; your option is to terminate.49 Data storage is billed per gigabyte on top of user licences, so cost also grows with the data you keep.49 Scilife has never published prices, so there’s no price history to compare, and we found no user reports of renewal increases. Ask for a renewal cap in writing.
  • If Scilife closes or is sold: the terms only cover data return at the end of the contract in general. They say nothing about insolvency, the service shutting down or a change of ownership, and there’s no escrow.49
  • Go-live: Scilife says core workflows run within weeks and full onboarding typically takes up to 90 days.35 One published customer took six months.50

Company and ownership

Scilife NV is a Belgian public limited company, enterprise number 0675.685.469, registered on 12 May 2017. Its registered seat has been at Cantersteen 47 in Brussels since June 2026.51 It traded as QbD Software until the 2021 rename.2 The founder handed the CEO role to a successor in September 2024 and stayed on the board.52

Growth equity firm Five Elms Capital invested in June 2024 and lists Scilife as an active portfolio company. Neither side disclosed the amount or stake.453 The company’s subscribed capital rose from €0.33 million at the end of 2023 to €7.69 million at the end of 2024.54

Scilife files abbreviated accounts, which don’t show revenue. It reported a net loss of €3.09 million for 2025, up from €1.61 million in 2024. Equity fell from €4.68 million to €1.59 million. In the notes, management says recurring revenue keeps rising and expects no further operating cash-flow deficit.55

Verdict

Scilife is an easy-to-learn, well-validated eQMS whose strongest ground is GMP work. It suits companies that span pharma and devices. Pure device teams, especially software or FDA-focused ones, will find risk, complaint reporting and design traceability thinner than in device-specialist tools. Prices are available only on request.

  1. Scilife: Privacy policy. Vendor legal page, checked 30 Sep 2026. ↩︎ ↩︎

  2. Scilife: QbD Software announces rebranding, Scilife is born. Press release, 7 Jun 2021. ↩︎ ↩︎

  3. Scilife: About Scilife. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎

  4. Scilife: Scilife and Five Elms Capital partnership. Press release, 6 Jun 2024. ↩︎ ↩︎

  5. Scilife: US subsidiary. Press release, 15 May 2023. ↩︎

  6. Scilife: Frequently asked questions. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎

  7. Scilife: Pricing for medical devices. Vendor pricing page and FAQ, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  8. Scilife: Design and Development solution for medical devices. Press release, 15 Jul 2025. ↩︎ ↩︎

  9. Capterra: Scilife reviews. Review site, reviews dated 2018–2022, checked in a browser 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  10. r/QualityAssurance: QMS software that allows to create tasks for document review. Community discussion, Aug 2025. ↩︎ ↩︎

  11. Scilife: Reperio customer story. Vendor customer story, checked 30 Sep 2026. ↩︎

  12. Scilife: Amnovis customer story. Vendor customer story, checked 30 Sep 2026. ↩︎

  13. Scilife: Integrations. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎

  14. Scilife: Medical device product development software. Vendor product page and FAQ, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎

  15. Scilife Help Center: What risk assessment methodologies are available?. Vendor help center, checked 30 Sep 2026. ↩︎ ↩︎

  16. Scilife Help Center: Prefixes in the Design & Development tool. Vendor help center, updated 29 Jan 2026. ↩︎ ↩︎ ↩︎

  17. Scilife: eQMS for medical devices. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎

  18. Scilife pricing page, archived June 2021. Wayback Machine, checked 30 Sep 2026. ↩︎

  19. Scilife pricing page, archived March 2025. Wayback Machine, checked 30 Sep 2026. ↩︎

  20. Scilife Help Center: Will I be charged for a deactivated user?. Vendor help center, checked 30 Sep 2026. ↩︎

  21. Capterra: Scilife (QualityKick). Review site listing, checked 30 Sep 2026. ↩︎

  22. Scilife Help Center. Vendor help center, 732 articles searched 30 Sep 2026. ↩︎ ↩︎

  23. Scilife: Product tours. Vendor self-guided tours (step text checked), 30 Sep 2026. ↩︎ ↩︎

  24. Scilife: Document control product tour. Vendor tour (step text checked), 30 Sep 2026. ↩︎

  25. Scilife Help Center: Can multiple users edit a form at the same time?. Vendor help center, checked 30 Sep 2026. ↩︎

  26. Scilife Help Center: Bulk download of published documents. Vendor help center, updated 15 Jan 2026. ↩︎ ↩︎

  27. Scilife Help Center: Creating a new record. Vendor help center, checked 30 Sep 2026. ↩︎

  28. Scilife Help Center: Traceability matrix. Vendor help center, updated 4 Mar 2026. ↩︎

  29. Scilife Help Center: Project import from Excel. Vendor help center, 20 Apr 2026. ↩︎

  30. Scilife Help Center: Linked vs standalone risk assessments. Vendor help center, checked 30 Sep 2026. ↩︎

  31. Scilife Help Center: How do I create an event?. Vendor help center, updated 24 Sep 2026. ↩︎

  32. Scilife: Quality events product tour. Vendor tour (step text checked), 30 Sep 2026. ↩︎

  33. Scilife Help Center: Creating a CAPA with various actions. Vendor help center, checked 30 Sep 2026. ↩︎

  34. Scilife Help Center: Adding an effectiveness check to a change request. Vendor help center, checked 30 Sep 2026. ↩︎

  35. Scilife: Medical device and diagnostic industry. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎

  36. Scilife Help Center: How to create assessments for a training. Vendor help center, checked 30 Sep 2026. ↩︎

  37. Scilife Help Center: When is retraining triggered?. Vendor help center, checked 30 Sep 2026. ↩︎

  38. Scilife Help Center: Document Control release notes. Vendor release notes, updated 3 Feb 2026. ↩︎

  39. Scilife Help Center: Registering the supplier qualification questionnaire and Setting a supplier to Audit Required. Vendor help center, checked 30 Sep 2026. ↩︎ ↩︎

  40. G2: Scilife reviews. Review site, checked in a browser 30 Sep 2026. ↩︎

  41. r/MedicalDevices: eQMS recommendations. Community discussion, Sep 2025. ↩︎

  42. G2: Scilife reviews, all pages. Review site, read in a browser while logged in, checked 2 Oct 2026. ↩︎

  43. Scilife: Security. Vendor website, checked 30 Sep 2026. ↩︎

  44. Scilife Help Center: Scilife 3-tier platform. Vendor help center, updated 3 Jun 2026. ↩︎

  45. Scilife: ISO 9001 certification. Vendor website, checked 30 Sep 2026. ↩︎

  46. Scilife: eQMS validation. Vendor website, checked 30 Sep 2026. ↩︎

  47. Scilife Help Center: Validation documentation. Vendor help center, updated 27 Nov 2025. ↩︎

  48. Scilife: Free trial. Vendor website (form redirects to a meeting booking), checked 30 Sep 2026. ↩︎

  49. Scilife: Terms and conditions. Vendor contract terms, version 2022-6, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  50. Scilife: EvidentIQ customer story. Vendor customer story, checked 30 Sep 2026. ↩︎

  51. Crossroads Bank for Enterprises: Scilife, 0675.685.469. Belgian company register, checked 1 Oct 2026. ↩︎

  52. Scilife: CEO appointment announcement. Press release, 2 Sep 2024. ↩︎

  53. Five Elms Capital: Scilife. Investor portfolio page, checked 1 Oct 2026. ↩︎

  54. National Bank of Belgium: Scilife annual accounts 2024 and 2023. Filed accounts, checked 1 Oct 2026. ↩︎

  55. National Bank of Belgium: Scilife annual accounts 2025. Filed accounts (abbreviated model), filed 29 Sep 2026, checked 1 Oct 2026. ↩︎

Visit the Scilife website (made by Scilife NV)

Notable features

Built-in document editorNoLive Edit opens documents in desktop Microsoft Word
Edit in Word or Google DocsYesMicrosoft Office integration with automatic versioning
SOP templates includedNot confirmed yetNo SOP library found; only design-report templates
Jira or Git integrationNot confirmed yetNo Jira or Git integration listed
IEC 62304 software featuresPartly or add-onFAQ claim only; no software-specific features
Validation package includedYesExecuted GAMP 5 package with IQ/OQ/PQ, included
Public APIPartly or add-onREST API exists; documentation not public
Single sign-on (SSO)YesMicrosoft Entra ID SSO with SCIM provisioning
Supplier portalNot confirmed yetSupplier questionnaires are uploaded manually
Training with quizzesYesTraining assessments; AI beta drafts them from documents
FDA MDR or EU vigilance reportingNot confirmed yetNo FDA MDR or EU vigilance reporting found
AI featuresYesTwo AI beta features since Nov 2025

ISO 13485 clause coverage

ClauseRequirementScilife
4.2.4Control of documents
4.2.5Control of records
6.2Training and competence
7.3Design and development
7.3.9Change control
7.4Supplier qualification and control
7.5Production records (DMR/DHR)
UDIUDI management (EU MDR, FDA)
8.2.2Complaint handling
8.2.3Regulatory reporting (FDA MDR, EU vigilance)
MDR 83Post-market surveillance
8.2.4Internal audit
8.3Nonconforming product
8.5.2Corrective action (CAPA)
ISO 14971Risk management file
IEC 62304Software lifecycle
Part 11Electronic signatures
Supported out of the boxPartial, or needs an add-onNot supportedNot confirmed yet

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