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* Products
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* ATMP
Standardize and track all your manufacturing processes
* Use Cases
* Implement a GMP-compliant QMS
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* Document Management
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* Become audit-ready
Stay audit-ready stress-free anytime
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Boost continuous learning
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Spreading the
light of quality in the Life Sciences
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Smart QMS for Medical Devices
Discover our smart QMS pricing plans for Medical Devices
Print & Reconciliation
Discover our Print & Reconciliation pricing plan
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BRING CLARITY TO YOUR QMS
Eliminate 80% of complex quality assurance tasks and turn quality into your
brightest asset. Infuse integrity, clarity, and compliance into your workflows
with Scilife.
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1
Automate all your processes. Gain a comprehensive quality management system.
2
Bring all your teams together and empower them with a quality-first mindset.
3
Achieve end-to-end traceability and data integrity compliance seamlessly within
your workflow.
TRUSTED BY LEADING QUALITY-FOCUSED ORGANIZATIONS IN THE LIFE SCIENCES
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SMART QMS SOLUTION
SIMPLIFY ALL YOUR QUALITY MANAGEMENT PROCESSES
STREAMLINE PROCESSES
Digitalize your Document and Record Management and automate your Compliance
Training with ease.
CUT THROUGH COMPLEXITY
Ensure audit readiness, manage CAPAs, Deviations, and Nonconformities
seamlessly. Integrate Change Control, and Risk Assessments for in-depth quality
oversight.
COLLABORATE ON QUALITY
Hit your KPIs and enhance performance with quality metrics. Foster collaboration
and shared ownership of quality initiatives.
Learn more about the QMS
SMART QMS SOLUTION FOR MEDICAL DEVICE
ACCELERATE YOUR CONCEPT-TO-PATIENT JOURNEY
SPEED UP APPROVALS
Eliminate confusion over tracking of elements in the design and development
workflow, accelerating time-to-market by up to 50%.
ELIMINATE SILOED ISSUES
Easily connect thousands of items, maintain version control, and automatically
link risk assessments with just one click.
ALIGN WITH REGULATIONS
Compliant with ISO 13485, our traceability matrix shows how design inputs
connect to user needs, and assess the impact of design changes on your
validation and verification processes.
Discover the QMS for Medical Device
CONTROLLED PRINTING SOLUTION
ENSURE 21 CFR 11-COMPLIANT CONTROLLED PRINTING
KEEP PAPER UNDER CONTROL
Integrate your essential apps for easy tracking and flawless audits, ensuring
FDA 21 CFR 11 compliance.
GET A SPOTLESS AUDIT TRAIL
Stay in the loop of who printed what, when and why. Recognize reprints
automatically, so you can trace back every print action.
RECONCILE WITH EASE
Use unique barcodes for full traceability to speed up and digitize the
reconciliation and take action quickly to find missing documents.
Learn more about the P&R Solution
BEAUTIFUL TEMPLATES FOR EVERY USE CASE.
We strongly believe in transparently doing our work so that our clients are in
the loop regarding every step of the assigned project.
Get Started
BEAUTIFUL TEMPLATES FOR EVERY USE CASE.
We strongly believe in transparently doing our work so that our clients are in
the loop regarding every step of the assigned project.
Get Started
* AUTOMATED TRAINING CYCLES
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* STREAMLINED DOCUMENT PROCESSES
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* AUDIT READINESS
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* ELIMINATED SPREADSHEET CHAOS
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* REAL-TIME QUALITY METRICS
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* CONSISTENT AND RELIABLE RECORDS
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* EFFICIENT VALIDATION WORKFLOWS
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* UNIFIED DATA REPOSITORY
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* DATA INTEGRITY
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* SIMPLIFIED REGULATORY SUBMISSIONS
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* RAPID APPROVALS
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* REDUCED COMPLIANCE RISK
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* AUTOMATED TRAINING CYCLES
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* STREAMLINED DOCUMENT PROCESSES
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* AUDIT READINESS
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* ELIMINATED SPREADSHEET CHAOS
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* REAL-TIME QUALITY METRICS
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* CONSISTENT AND RELIABLE RECORDS
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* EFFICIENT VALIDATION WORKFLOWS
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* UNIFIED DATA REPOSITORY
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* DATA INTEGRITY
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* SIMPLIFIED REGULATORY SUBMISSIONS
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* RAPID APPROVALS
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* REDUCED COMPLIANCE RISK
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* AUTOMATED TRAINING CYCLES
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* STREAMLINED DOCUMENT PROCESSES
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* AUDIT READINESS
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* ELIMINATED SPREADSHEET CHAOS
*
* REAL-TIME QUALITY METRICS
*
* CONSISTENT AND RELIABLE RECORDS
*
* EFFICIENT VALIDATION WORKFLOWS
*
* UNIFIED DATA REPOSITORY
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* DATA INTEGRITY
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* SIMPLIFIED REGULATORY SUBMISSIONS
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* RAPID APPROVALS
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* REDUCED COMPLIANCE RISK
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* AUTOMATED TRAINING CYCLES
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* STREAMLINED DOCUMENT PROCESSES
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* AUDIT READINESS
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* ELIMINATED SPREADSHEET CHAOS
*
* REAL-TIME QUALITY METRICS
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* CONSISTENT AND RELIABLE RECORDS
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* EFFICIENT VALIDATION WORKFLOWS
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* UNIFIED DATA REPOSITORY
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* DATA INTEGRITY
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* SIMPLIFIED REGULATORY SUBMISSIONS
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* RAPID APPROVALS
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* REDUCED COMPLIANCE RISK
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Industries
DESIGNED FOR LIFE SCIENCES
PHARMA & BIOTECH
Nurture a company-wide quality culture and continuous improvement.
Learn more →
CRO / CMO
Accelerate efficiency and meet trial deadlines.
Learn more →
MEDICINAL CANNABIS
Comply with stringent, fast-changing regulations.
Learn more →
MEDICAL DEVICES & IVD
Bring high-quality Medical Devices to market faster.
Learn more →
ATMPS
Standardize and track materials and manufacturing processes.
Learn more →
Trust and security
CONNECT YOUR ENTIRE COMPANY ON A SINGLE, SECURE PLATFORM
At Scilife, your data security is our top priority. Understanding the critical
importance of data security and compliance in the Life Sciences industry, we
employ stringent measures across product and infrastructure security,
monitoring, reliability, compliance, and privacy to keep your data safe.
Know more about Scilife security
SMART QUALITY
WHAT SETS US APART?
Empower everyone to take ownership of quality with Scilife
BREAK THE QA UNIT BARRIERS
Tune into knowledge at scale with our Academy, use data insights as your
roadmap, and engage everyone on quality through gamified workflows. Discover how
to instill a Smart Quality mindset in your organization.
01
INSTILL A QUALITY-FIRST MINDSET
Inspire to undertake quality-focused actions and foster a culture where
continuous learning leads to continuous improvement with the Scilife Academy.
02
ENGAGE EVERYBODY ON QUALITY
Ready to level up? Move through our gamified workflows, designed to keep teams
not just involved but truly invested in assurance quality.
03
TURN YOUR DATA INTO ACTION
Get a competitive edge with benchmarked data. Scilife KPIs Advanced Analytics
provide timely insights for prompt, data-informed decisions.
MEET OUR HAPPY CUSTOMERS
REAL VOICES, REAL RESULTS
Life sciences companies transform their teams into quality boosters with
Scilife.
But don't just take our word for it!
* “Before Scilife, we couldn’t really be sure who completed a task. Scilife
tracks everything so we can see who does things, who signs off tasks and who
reviews them. That’s a really big improvement.”
JOLANDA OORTHUIZEN
Quality Assurance and Regulatory Affairs Manager, LivAssured
* “Scilife has made our life easier in so many ways. One of the things I like
the most is how it integrates different processes. It gives a bigger picture
of everything and allows us to keep track of deviations and see opportunities
for improvement.”
DANIELE SCALCO VASCONCELOS
Quality Assurance and regulatory affairs manager, Idevax
* “Doing an audit with Scilife at your fingertips was amazing. The auditors
were blown away at how easy it was for us to navigate everything. They were
just so impressed.”
KERYN DAVIES
Quality Manager, Helius
* “Before Scilife I had a QA officer who lived by the photocopier. Now we get a
lot more work done and the time saved is enormous.”
TINNE BOCKX
QA Manager, Inovet
* “I think Scilife is the best product in the market. We built our ISO 13485
QMS on the Scilife platform and have been very happy with it.”
ANTTI ROINE
CEO, Olfactomics
* “Scilife has definitely helped improve our communication and collaboration
within our quality team and between other departments as well.”
CIANNA SERA
QA Specialist, Pendulum
* “Before Scilife, we couldn’t really be sure who completed a task. Scilife
tracks everything so we can see who does things, who signs off tasks and who
reviews them. That’s a really big improvement.”
JOLANDA OORTHUIZEN
Quality Assurance and Regulatory Affairs Manager, LivAssured
* “Scilife has made our life easier in so many ways. One of the things I like
the most is how it integrates different processes. It gives a bigger picture
of everything and allows us to keep track of deviations and see opportunities
for improvement.”
DANIELE SCALCO VASCONCELOS
Quality Assurance and regulatory affairs manager, Idevax
* “Doing an audit with Scilife at your fingertips was amazing. The auditors
were blown away at how easy it was for us to navigate everything. They were
just so impressed.”
KERYN DAVIES
Quality Manager, Helius
* “Before Scilife I had a QA officer who lived by the photocopier. Now we get a
lot more work done and the time saved is enormous.”
TINNE BOCKX
QA Manager, Inovet
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TURN QUALITY INTO YOUR BRIGHTEST ASSET WITH SCILIFE
When we embrace quality, brilliant things happen!
Book a demo
Marketing Lifecycle Stage
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EMEA Office
Groenenborgerlaan 16
2610 Antwerpen
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
PRODUCT
* QMS Software
* QMS for Medical Devices
* Print & Reconciliation
* What is Smart Quality
* Gamification
* Advanced Analytics
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* Integrations
* FAQ
PRICING
* Pricing Smart QMS
* Pricing Smart QMS for Medical Device
* Pricing Print & Reconciliation
INDUSTRIES
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* CRO/CMO
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COMPANY
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RESOURCES
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SOLUTIONS
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* Smart Quality Management Software
* Document Management Software
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* Quality Events Software
* Change Control Software
* Risk Management Software
* Audits Software
* Quality KPIs
* Corrective & Preventive Actions Software
* Equipment Management Software
* QMS for Medical Devices
* Print & Reconciliation Software
* Advanced Therapy Medicinal Product
* QMS for Pharma & Biotech
CONTACT US
EMEA Office
Groenenborgerlaan 16
2610 Antwerpen
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
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