“Scilife is an intuitive system that is easy for everyone. After a 15-minute introduction, they get right to it. And in a matter of hours, they’re using it without any problem.”
Life sciences industry focus
Purpose-built for pharma, biotech, medTech
Purpose-built for MedTech only
Core QMS functionalities
Full suite: Document Control, Training, CAPA, Change Control, Risk, Audits, Supplier, Equipment, KPIs, Design & Development and more
Includes core QMS modules (Document, Training, CAPA, Change, Risk), plus specific MedTech and clinical modules such as Design Control, but misses Equipment and KPI modules. No competence tracking
Regulatory compliance
FDA 21 CFR Part 11 & 820, EU Annex 11, ISO 13485, 21 CFR Part 210/21, ISO 9001, GAMP 5, MDR/IVDR, GMP, GDP, GCP, GvP
21 CFR Part 11 and 820, ISO 14971:2019, ISO 13485:2016; solid MedTech compliance coverage
User experience
Modern, intuitive, minimal learning curve that ensures seamless adoption from Product, R&D, to Quality teams
Mixed reviews: some find it easy to use, but many note rigid workflows, time-consuming document uploads, and excessive clicks
Scalability and fit
Flexible for SMEs and scale-ups, licensing adapts as company grows with tiered plans. Ideal for large organizations that want to keep their processes streamlined and simple
Best fit for MedTech startups/SMEs; less suitable for larger or non-MedTech companies
Validation ease
Out-of-the-box GAMP 5 package, re-validation after updates, three environments (test/validation/production)
Automated risk-based validation with each update, aligned with FDA CSA and ISO standards
Integration capabilities
Integrations possible with Microsoft Office, API, Azure AD/Entra ID, Power BI, Tableau, Okta, and more
API connections to ERP, CRM, PLM, Jira, etc., but relies on built-in text editor with no MS Office integration
Platform security
Secure virtual private cloud (AWS) with EU/US data residency, strong encryption, and hassle-free managed updates
Cloud-hosted, compliant, strong security
Onboarding and implementation ease
Fast implementation with an onboarding manager and customer success experts
Users value quick and efficient QMS implementation
Level of customer support
Dedicated customer success managers, 1:1 technical support, and internal chat
Dedicated customer managers, onboarding, and online help
Quality community and learning
Rich ecosystem with training videos, knowledge base, monthly webinars, and Scilife Academy with courses and certifications, all for free
Provides the Greenlight Guru Academy, workshop, and structured training programs, but these are primarily focused on MedTech compliance and product onboarding
Clear pricing model
Transparent tiered plans (Essential, Core, Core+) that adapt as you grow - robust enough for SMEs, scale-ups, and larger organizations
Plan-based (Essentials, Plus, Professional), annual subscriptions
Return on investment
Faster ROI with lower upfront costs, free plan, and quick onboarding
ROI can be good for MedTech startups due to fast setup, but high price and limited customization make it a less attractive solution long-term
Free trial
Yes! Includes:
No free plan available
Scilife evolves with your organization, from early-stage startups to global enterprises.
Flexible licensing and product scalability ensure that as your teams expand, your QMS continues to fit seamlessly, maintaining compliance and efficiency at every stage of growth.
With an intuitive interface, guided tours, and the Scilife Academy, teams can start working productively from day one. Scilife streamlines collaboration, minimizes manual work, and keeps quality processes moving smoothly without unnecessary clicks or complexity.
“Scilife is an intuitive system that is easy for everyone. After a 15-minute introduction, they get right to it. And in a matter of hours, they’re using it without any problem.”
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Industry
"The speed with which we can process documents at SHOEBOX is now almost overwhelming. Amanda is our QA department. She's able to kind of handle this entire volume of work as we grow and as we move because she has Scilife as a tool to rely on."
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Industry
“That’s what I really like about Scilife. You don’t need to do the uploads and downloads, all the changes are there. If you make a change, it’s immediately there. You just get a new version and that’s just really good because otherwise, if you have it locally on your computer, sometimes computers crash, things are lost, or you don’t know where you saved it.”
Company Size
Industry
EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
