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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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Automate all your processes. Gain a comprehensive quality management system.

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Bring all your teams together and empower them with a quality-first mindset.

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Achieve end-to-end traceability and data integrity compliance seamlessly within your workflow.

Trusted by leading quality-focused organizations in the life sciences

  • Image of NatuEra's logo, user of Scilife Smart QMS
  • Image of Puro's logo, user of Scilife Smart QMS
  • Image of Polpharma's logo, user of Scilife Smart QMS
  • Image of Novartis' logo, user of Scilife Smart QMS
  • Image of Biocartis' logo, user of Scilife Smart QMS
  • Belgian red cross becomes Scilife's customer | Scilife

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.

Image that shows Document Control Solution from Scilife Smart 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.

Image that shows Design and Development Software for Medical Devices from Scilife Smart QMS

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.

Image that shows Print and Reconciliation solution from Scilife Smart QMS
  • 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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Industries

Designed for Life Sciences

Icon that represents Scilife Smart QMS for Pharma and biotech companies

Pharma & Biotech

Nurture a company-wide quality culture and continuous improvement.

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Icon that represents Scilife Smart QMS for CRO and CMO companies

CRO / CMO

Accelerate efficiency and meet trial deadlines.

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Icon that represents Scilife Smart QMS for Medicinal Cannabis companies

Medicinal Cannabis

Comply with stringent, fast-changing regulations.

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Icon that represents Scilife Smart QMS for Medical Device and IVD companies

Medical Devices & IVD

Bring high-quality Medical Devices to market faster.

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Icon that represents Scilife Smart QMS for ATMPs companies

ATMPs

Standardize and track materials and manufacturing processes.

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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.

Illustration that represents how Scilife smart QMS protects and secures your data
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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.
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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.
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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!

  • “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.”
    Photo of Keryn Davies, Quality Manager at Helius | Scilife
    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 at Inovet | Scilife
    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 at Olfactomics | Scilife
    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 at Pendulum | Scilife
    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 at LivAssured | Scilife
    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 at Idevax | Scilife
    Daniele Scalco Vasconcelos
    Quality Assurance and regulatory affairs manager, Idevax
Illustration that represents how Scilife smart QMS can help you improve your quality processes

Turn quality into your brightest asset with Scilife

When we embrace quality, brilliant things happen!
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