Scilife

Smart QMS platform for life sciences digitizing document control, training, CAPA, and quality events, with ISO 9001:2015 certification.

Scilife, founded in 2017 and headquartered in Antwerp, Belgium, provides a quality management platform for life sciences companies covering document control, training, CAPA, and quality events, positioning quality as a proactive, data-driven function. The company documents ISO 9001:2015 certification on its own site (no ISO 27001 or SOC 2 was publicly verifiable). Its AI-assisted capabilities are emerging rather than core, so validate which quality workflows include AI assistance today during evaluation.

Headquarters
Antwerp, Belgium
Founded
2017
Deployment options
cloud
Website
https://www.scilife.io
LinkedIn
https://www.linkedin.com/company/41053928

Categories

AI Use Cases

  • Manufacturing Quality Control

Vendor Scorecard

50% — Partial coverage. Coverage score — how completely Atlas documents Scilife across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.

Compliance & Validation — Not documented by Atlas

Ask the vendor: Which compliance certifications (HIPAA, 21 CFR Part 11, SOC 2, GxP) do you hold?

Deployment & Hosting — Documented

cloud

Pricing Transparency — Not documented by Atlas

Ask the vendor: What is your pricing model, and what drives total cost of ownership?

Implementation & Onboarding — Not documented by Atlas

Ask the vendor: What is a realistic implementation timeline, and what onboarding support is included?

Organization & Role Fit — Documented

Biotech Startup, Mid-Size Biotech, Regulatory Affairs, IT / Digital

Solution Scope — Documented

Manufacturing Quality Control

Company Viability — Partially documented

Private, Founded 2017

Always ask the vendor

Not captured in Atlas data — confirm directly. Excluded from the score above.

Data Rights & IP

Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?

Model Credibility & Explainability

Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?

Questions to Ask This Vendor

  • Which quality workflows include AI assistance today versus roadmap?
  • What information-security audit evidence is available beyond ISO 9001?
  • How does the platform support GxP computerized-system validation?
  • What does migration from our current QMS look like?