“When you open a CAPA and it automatically triggers the forced review on the documents or vice versa, or from an event to a CAPA, that’s so useful. The links between the different modules, that's really the strong suit of Scilife.”
Life sciences industry focus
Purpose-built for pharma, biotech, medTech
Also focused on pharma, biotech, and medtech
Core QMS functionalities
Full suite: Document Control, Training, CAPA, Change Control, Risk, Audits, Supplier, Equipment, KPIs, Design & Development and more
Covers core QMS modules (Document, Training, CAPA, Change, Audits), missing equipment, and calibration management
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
FDA 21 CFR Part 11 & 820, ICH Q10, ISO 13485, GxP, ICH Q10, ISO 27001:2022, GAMP 5
User experience
Modern, intuitive, minimal learning curve that ensures seamless adoption from Product, R&D, to Quality teams
Praised for ease of use and quick setup, but users also report formatting issues, messy documents, difficult navigation in Sandbox, and limitations in document editing
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
Well-suited for startups and small companies, but often seen as less fit for larger organizations
Validation ease
Out-of-the-box GAMP 5 package, re-validation after updates, three environments (test/validation/production)
Users must still qualify Qualio as a SaaS provider, plan computer software assurance activities, evaluate risks, and prepare their own Validation Summary Report (VSR)
Integration capabilities
Integrations possible with Microsoft Office, API, Azure AD/Entra ID, Power BI, Tableau, Okta, and more
Broad API integrations with Google Suite, Asana, Jira, Azure DevOps, etc., but no Microsoft Office integration
Platform security
Secure virtual private cloud (AWS) with EU/US data residency, strong encryption, and hassle-free managed updates
Cloud-hosted and ISO 27001:2022 certified; strong security, but less flexible in data residency options
Onboarding and implementation ease
Fast implementation with an onboarding manager and customer success experts
Quick setup is often praised, but validation requirements can slow rollout
Level of customer support
Dedicated customer success managers, 1:1 technical support, and internal chat
Commended for onboarding and customer support, though ongoing support is seen as less tailored
Quality community and learning
Rich ecosystem with training videos, knowledge base, monthly webinars, and Scilife Academy with courses and certifications, all for free
Knowledge base available, but lacks structured community learning or certifications
Clear pricing model
Transparent tiered plans (Essential, Core, Core+) that adapt as you grow - robust enough for SMEs, scale-ups, and larger organizations
Subscription-based pricing geared mainly toward small-to-mid companies, but less transparent and flexible compared to Scilife
Return on investment
Faster ROI with lower upfront costs, free plan, and quick onboarding
ROI is slower due to validation burden, limited scalability, and editing inefficiencies
Free trial
Yes! Includes:
No free plan available
Whether you’re a fast-growing SME or an established enterprise, Scilife adapts to your size and structure. Its tiered plans allow teams to expand their QMS capabilities as operations evolve without costly migrations or added complexity.
Scilife includes a complete GAMP5 validation package with automatic re-validation after updates and three dedicated environments for testing, validation, and production. Teams save time and reduce the paperwork involved in validation while staying fully audit-ready.
“When you open a CAPA and it automatically triggers the forced review on the documents or vice versa, or from an event to a CAPA, that’s so useful. The links between the different modules, that's really the strong suit of Scilife.”
Company Size
Industry
“Validation is a huge work. So the fact that Scilife is validated, it's such a big benefit. If you have to choose a system and it is not validated, I wouldn't even start.”
Company Size
Industry
“We work with several remote partners and we need to provide them with up-to-date quality documents, Scilife serves as a great time-saver… it makes it possible at all for us to work the way we do.”
Company Size
Industry
EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
