"What we really wanted was an out-of-the-box solution that didn’t require a lot of input or expertise from us concerning validation, ongoing maintenance, or configuration. Scilife was a perfect match!"
Life sciences industry focus
Purpose-built for pharma, biotech, medTech
Designed for pharma, biotech, medtech and other industries
Core QMS functionalities
Full suite: Document Control, Training, CAPA, Change Control, Risk, Audits, Supplier, Equipment, KPIs, Design & Development and more
Includes core QMS modules, but configuration may be needed to improve functionality
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
Covers key regulations such as FDA 21 CFR Part 11, ISO, CLIA, EU MDR, GAMP 5, etc., like Scilife
User experience
Modern, intuitive, minimal learning curve that ensures seamless adoption from Product, R&D, to Quality teams
Complex to configure, poor UX reported; steep learning curve, requires heavy training that makes organization-wide uptake difficult
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 for large global organizations, not ideal for small companies. Not ideal for SME companies or medical devices due to poor traceability matrix
Validation ease
Out-of-the-box GAMP 5 package, re-validation after updates, three environments (test/validation/production)
Validation tool based on FDA best practices available. However, validation typically requires more time, IT resources, and consulting support
Integration capabilities
Integrations possible with Microsoft Office, API, Azure AD/Entra ID, Power BI, Tableau, Okta, and more
Extensive enterprise integrations: ERP, CRM, LIMS, MES, PDM; custom integrations via API, but heavier and enterprise-oriented
Platform security
Secure virtual private cloud (AWS) with EU/US data residency, strong encryption, and hassle-free managed updates
Cloud or on-premise deployment; secure but more rigid and IT-heavy to maintain
Onboarding and implementation ease
Fast implementation with an onboarding manager and customer success experts
Implementation can take many months, requiring more resources and consulting
Level of customer support
Dedicated customer success managers, 1:1 technical support, and internal chat
Enterprise support with training and validation services, but less personalized
Quality community and learning
Rich ecosystem with training videos, knowledge base, monthly webinars, and Scilife Academy with courses and certifications, all for free
Primarily technical documentation and static resources. Lacks ongoing community-driven learning
Clear pricing model
Transparent tiered plans (Essential, Core, Core+) that adapt as you grow - robust enough for SMEs, scale-ups, and larger organizations
Enterprise-tier pricing, higher upfront cost, less flexibility for smaller teams
Return on investment
Faster ROI with lower upfront costs, free plan, and quick onboarding
Higher cost and slower ROI due to long, resource-heavy implementation
Free trial
Yes! Includes:
No free plan available
Scilife includes GAMP5 validation packages per module and three environments (test, validation, production). With everything pre-configured for life sciences, teams save time, reduce IT dependency, and achieve compliance faster.
"What we really wanted was an out-of-the-box solution that didn’t require a lot of input or expertise from us concerning validation, ongoing maintenance, or configuration. Scilife was a perfect match!"
Company Size
Industry
"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."
Company Size
Industry
“Scilife really helps you to be compliant and it saves you a lot of money and time that you can then spend on other things. If you are in a small startup company, money is not unlimited, you need to be careful with 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
