“We had demos for several systems, but I thought of Scilife as by far the clearest and intuitive system of them all. It's intuitive and flexible, web-based, and modularly assignable per individual user.”
Life sciences industry focus
Purpose-built for pharma, biotech, medTech
Focused on pharma, biotech, medtech, and cosmetics
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), although many users complain about the audit module being ineffective
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, EU Annex 11, FDA regulations, GMP, EU MDR, ISO 9001:2015, 13485:2016, 14791:2019, 27001:2022
User experience
Modern, intuitive, minimal learning curve that ensures seamless adoption from Product, R&D, to Quality teams
Mixed reviews. While the user interface is intuitive, many users mention difficult navigation and excessive clicks needed to access features
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
Scales with business: built on Salesforce, which offers strong scalability potential
Validation ease
Out-of-the-box GAMP 5 package, re-validation after updates, three environments (test/validation/production)
Solutions come with validation packages (CFR Part 11 and EU Annex 11 compliant), but the software is not fully validated according to GAMP 5 guidelines, which means you need to complete parts of the validation process yourself
Integration capabilities
Integrations possible with Microsoft Office, API, Azure AD/Entra ID, Power BI, Tableau, Okta, and more
Integrations with Microsoft Office 365, Google Docs, and ERP systems through its native Salesforce platform
Platform security
Secure virtual private cloud (AWS) with EU/US data residency, strong encryption, and hassle-free managed updates
Enterprise-level security via the Salesforce platform, native compliance, data integrity, and scalability
Onboarding and implementation ease
Fast implementation with an onboarding manager and customer success experts
Claims ‘off-the-shelf’ deployment, fast install via pre-configured modules. But user reviews report time spent customizing workflows, navigation, and signature behavior
Level of customer support
Dedicated customer success managers, 1:1 technical support, and internal chat
Users report knowledgeable and responsive customer support
Quality community and learning
Rich ecosystem with training videos, knowledge base, monthly webinars, and Scilife Academy with courses and certifications, all for free
Documentation, training resources, knowledge base. But not a broad community-driven learning culture
Clear pricing model
Transparent tiered plans (Essential, Core, Core+) that adapt as you grow - robust enough for SMEs, scale-ups, and larger organizations
Pricing plans are not publicly transparent. You need to contact their sales team for a personalized quote
Return on investment
Faster ROI with lower upfront costs, free plan, and quick onboarding
Promotes faster ROI with pre-validated, out-of-the-box modules — though setup may still require Salesforce-level configuration for tailored workflows
Free trial
Yes! Includes:
No free plan available
Scilife is a pre-validated GAMP 5 solution that removes most of the validation effort from your team. Automatic updates and built-in validation tools make it easy to stay compliant, release after release, without heavy documentation or downtime.
We go beyond software to strengthen your team’s quality mindset. Through Scilife Academy, monthly webinars, and expert-led resources, you have continuous access to learning that supports your compliance, maturity, and quality culture.
“We had demos for several systems, but I thought of Scilife as by far the clearest and intuitive system of them all. It's intuitive and flexible, web-based, and modularly assignable per individual user.”
Company Size
Industry
“Life science companies have a big, big focus on validation of their systems. Scilife has a strong validation package, so I’d recommend it. The simplicity of the user interface is also excellent.”
Company Size
Industry
“It's very search-friendly within documents. With all our changes that are occurring in such a fast-paced environment, we have a lot going on. So being able to search for something in the search bar makes it really, really easy and more efficient for us.”
Company Size
Industry
EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
