Scilife
#1 eQMS Software for Life Sciences
By Scilife N.V. · HQ Brussels, Belgium · 4.0/5 Value-Position score (estimate)
Positioning guardrails
Best for
- Life sciences quality teams in pharma, biotech and medical devices that need a validated eQMS
- QA and regulatory leaders replacing manual, paper-based document control and training tracking
- Medical device teams managing design controls, risk files and change control under ISO 13485 and EU MDR
- Organisations preparing for FDA, EU or GxP inspections that need audit-ready records and traceability
Ideal size: 20-500 users people · Regulated life sciences org with a dedicated QA/quality function
Not for
- Companies outside regulated life sciences with no GxP or ISO quality obligations
- Teams wanting a free or fully self-serve tool - Scilife is quote-based with no public list pricing
- Organisations that only need a simple document repository or task tracker
- Buyers who require deep native ERP or CRM connectors out of the box
Value metrics scorecard
Time-to-Value
About 3 months
~90 days to first production value
Total Cost of Ownership
$30,000/yr
Starts at $10,000 · Quoted per active user, billed annually. All tiers include support, onboarding guidance and a GAMP5 validation documentation package.
Implementation Friction
3/5
Engineering + admin effort required
Value-Position score
out of 5 · model estimate
Full cost breakdown
Mandatory implementation fee
None
Seat tiers
Read-only and full users; administrators and managers are charged at the same rate as full users.
Add-on costs
- Additional file storage beyond the amount included in the contract
- Printing and Reconciliation is sold as a separate Scilife product
Company & support
Who is behind Scilife, and how your team gets help once it is live.
Company
- Founded
- Not recorded
- Headquarters
- Brussels, Belgium
How you get support
- PhoneNot listed
- EmailNot listed
- Live chatNot listed
- Support portal / ticketsAll plans
- Community forumNot listed
- Help centre / docsAll plans
- Dedicated account managerNot listed
- In person / on-siteNot listed
- Hours
- Not recorded
- Response time
- Not stated
Support is included in the plan price with no extra fees. The pricing page lists knowledge base access, Scilife Academy training videos, an online service desk and 1:1 technical support for every tier, plus access to customer success experts.
“Not listed” means the vendor’s public pages don’t mention that channel, not that it is unavailable. Ask about it during evaluation.
Market position
Where Scilife sits against its closest alternatives. Pick any two of cost, speed, friction and buyer score, and up to 9 companies to compare.
Quadrant view
Typical annual cost × Time-to-value
The lines cross at the median of the solutions shown, so about half sit on each side of each line. A dashed ring marks an outlier pinned to the edge; hover for its value.
Companies on the chart 6 / 10
- Scilife
- Persefoni
- Trend Micro
- Tenable
- Mimecast
- Cohesity
Add or change companies
Up to 10 companies including Scilife. Listed closest first.
Stack fit signal
Compatibility with standard B2B ecosystems.
No supported MCP path today, so it cannot be driven from an AI client.
AI & MCP readiness
What Scilife ships in AI, and what it asks of your ecosystem.
Compliance attestations
* IAPP AIGP certifies individuals, not products. It means named staff hold the credential — not that the platform does.
Bottom line
Scilife is a validated eQMS for life sciences. Pharma, biotech, medical device and healthcare logistics teams use it to run document control, training and competences, quality events, CAPA, change control, audits, supplier management, risk and equipment in one system aligned with 21 CFR Part 11, Annex 11, GxP, ISO 13485, FDA QMSR and EU MDR. Plans run from Essential to Core+, all including support, onboarding guidance and a GAMP5 validation package. Pricing is quote-based per active user.
Frequently asked questions
How is Scilife priced?
Scilife does not publish list prices. Plans are Essential, Core and Core+, quoted per active user and billed annually. Read-only users can view data and sign assigned trainings but cannot create records; administrators and managers cost the same as full users. Support, onboarding guidance and the validation documentation package are included, and a free trial is available.
Is Scilife validated, and does it come with validation documentation?
Yes. Scilife states it is fully validated according to GAMP5 and 21 CFR Part 11, and the price includes a drafted, executed and signed-off validation documentation package that customers can use as the basis for their own validation. Customers also get three environments: test, validation and production.
Which regulations and standards does Scilife support?
Scilife is built around 21 CFR Part 11, Annex 11, ICH guidelines and broader GxP requirements, and for medical devices ISO 13485, FDA QMSR and EU MDR. The eQMS covers document control, training, quality events, CAPA, change control, audits, supplier management, risk assessment and equipment qualification and calibration.
Where is our data hosted and can we meet GDPR requirements?
Scilife runs on Amazon AWS in a virtual private cloud. Data is encrypted in transit and at rest, backed up every five minutes with 30-day retention, and document storage uses Amazon S3. Customers who need GDPR compliance are hosted in a European data centre; US hosting is also available.
What support is included?
Support is included in every plan at no extra cost. The pricing page lists an online service desk, knowledge base access, Scilife Academy training videos, onboarding guidance and 1:1 technical support, plus access to customer success experts. No public SLA or 24/7 commitment is stated.
Does Scilife have AI features?
No AI product features are described on Scilife's public pages. The privacy policy mentions that logs of user inputs and AI model outputs are retained for up to 45 days, but no AI capability, model provider or AI pricing is documented, so buyers should confirm current AI roadmap directly with the vendor.