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    Modernize GMP compliance to simplify quality, streamline documentation, and cut audit stress.

    Pharma runs on compliance, but outdated systems slow you down. Aligned with GxP, GAMP5, Annex 11, and 21 CFR Part 11, Scilife delivers a modern, inspection-ready QMS with a guided, low-risk, low-effort transition.

    Ask our experts anything Explore Scilife Smart eQMS
    Illustration of teams overcoming GMP compliance barriers and audit challenges | Scilife
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    Challenges in pharmaceutical quality management: what’s at risk when critical systems stay frozen

    Validated systems that once kept you safe are now limiting visibility, draining resources, and increasing the risk of data integrity issues.

    Innovation stalls, slow releases, change controls, and rigid processes.

    Controlled change management with clear impact assessments.

    Validation-ready setup aligned with GAMP5 and CSA.

    Dedicated onboarding manager for a smooth transition.

    Don’t let legacy validated systems limit your compliance readiness — modernize safely with controlled changes, full traceability, and GxP-aligned validation.
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    Enhance GMP control and traceability with a modern QMS and a guided, low-risk transition

    Scilife helps pharma teams modernize their QMS and simplify compliance without losing control, by guiding them on a systemized and quick implementation process:

    Scilife eQMS audit trail | Scilife

    Full traceability with audit trails and secure FDA Part 11 signatures.

    Scilife eQMS change management feature | Scilife

    Controlled change management with clear impact assessments.

    Scilife eQMS document management and compliance | Scilife

    Validation-ready setup aligned with GAMP5 and CSA.

    Onboarding manager for easy eQMS implementation | Scilife

    Dedicated onboarding manager for a smooth transition.

    Up to 35%

    faster batch release

    Up to 80%

    fewer recurring deviations

    90 days

    onboarding

    Built for pharma – validated, compliant, and audit-ready

    Scilife is purpose-built for GxP. Regulated pharma, veterinary, and cannabis manufacturers rely on Scilife to modernize safely.

    Why pharma trusts Scilife:

    Microscope illustration | Scilife

     

    —   Proven success with GxP-regulated manufacturers.
    —   Purpose-built for regulated environments, not adapted from generic SaaS.
    —   Onboarding and validation support embedded into every implementation.

    Engineered for compliance:

    Ruler illustration to symbolize precision | Scilife

     

    —   GxP, GAMP5, Annex 11, 21 CFR Part 11 aligned.
    —   Continuous validation packages.
    —   Complete traceability and version control.
    —   Supports critical GMP workflows.
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    Scilife compliance and validation

    See how Scilife approaches software validation and aligns with GAMP 5 and 21 CFR Part 11.

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    Data security and recovery: let's get protected

    Explore how Scilife secures its platform, manages access, and safeguards regulated data.

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    Scilife competitive advantages for cGMP

    Discover how Scilife’s workflows and features align with core cGMP expectations.

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    Scilife switch for turning quality into your brightest asset | Scilife

    Move your GMP compliance forward, backed by a clear, low-risk upgrade path.

    Compliance shouldn’t hold you back — it should give you the confidence to evolve.

    With Scilife, pharma teams move faster by lightening documentation, lowering audit burden, and simplifying routine quality tasks, guided by a transition tailored to regulated environments.

    Chat with an expert Explore Scilife Smart eQMS

    FAQs

    Is Scilife compliant with GxP, GAMP5, Annex 11, and 21 CFR Part 11?

    Yes. Scilife is fully aligned with GxP, GAMP5, Annex 11, and 21 CFR Part 11. The platform includes complete audit trails, version control, secure FDA Part 11 e-signatures, and controlled access — all essential for maintaining data integrity and inspection readiness in pharmaceutical environments.

    How do you ensure data integrity in Scilife’s QMS software?

    Data integrity in pharma requires adherence to ALCOA+ principles, audit trails, controlled access, and validated systems. Scilife ensures data integrity through:

    • Automated audit trails
    • Version control
    • Secure Part 11 e-signatures
    • Role-based access and permissions
    • A fully validated environment aligned with GAMP5

    This keeps all quality records complete, consistent, and inspection-ready.

    How does QMS software streamline document control?

    QMS software automates document creation, review, approval, distribution, version control, and training. With Scilife, pharma teams gain:

    • Automated workflows and review cycles
    • Secure FDA Part 11 signatures
    • Complete audit trails
    • Real-time visibility and traceability

    This reduces manual work and eliminates document-related compliance risks.

    Does Scilife support GMP-critical workflows like CAPA and Change Control?

    Yes. Scilife supports key GMP workflows, including Deviations, CAPA, Change Control, Document Management, Training, and other quality processes required for batch release and regulatory inspections. All workflows are designed to maintain compliance and full traceability.

    Is Scilife suitable for veterinary and medicinal cannabis manufacturers?

    Absolutely. Scilife supports compliance for pharmaceutical, veterinary, and medicinal cannabis manufacturers. The platform adapts to different GxP requirements, including GMP for pharmaceutical, veterinary, and medicinal cannabis manufacturers.

    What is a cloud-based QMS software? Is it secure for pharma environments?

    A cloud-based QMS software is quality management software hosted in the cloud rather than installed on local servers. It allows pharma teams to access controlled documents, workflows, and records from anywhere while maintaining full compliance with GxP, GAMP5, Annex 11, and 21 CFR Part 11.

    Scilife is a cloud-based, inspection-ready QMS hosted on AWS, designed to keep validation and data integrity fully intact.

    How does Scilife support validation for pharma companies and Computer Software Assurance principles?

    Scilife removes up to 95% of the validation burden through a fully validated SaaS platform aligned with GAMP5 and 21 CFR Part 11, validated on AWS. Customers receive a complete, risk-based validation documentation package with drafted, executed, and approved validation deliverables. Standard workflows are pre-validated, making it easy to adopt the platform without repeating full internal validation.

    Equally, Scilife’s platform aligns with FDA CSA principles by focusing on risk-based validation, critical thinking, and assurance activities proportional to system impact. This reduces unnecessary documentation while maintaining strong compliance.

    How do you implement a quality management system like Scilife in pharma?

    Implementing a QMS in pharma requires a validated platform, defined processes, change control, and training. Scilife simplifies QMS implementation with:

    • A 1-hour implementation planning meeting
    • A clear onboarding roadmap
    • Pre-validated workflows aligned with GAMP5 and CSA
    • Complete validation documentation packages

    Most pharma Scilife customers go live in 90 days, depending on the scope.

    Can Scilife reduce the cost and effort of implementing a new QMS?

    Yes. Scilife provides a structured implementation plan with a kickoff session, defined milestones, and regular follow-ups. You receive access to Validation and Production environments, templates, and user training materials to ensure a smooth and compliant rollout.

    Also, by providing a pre-validated platform and complete validation documentation package, Scilife significantly reduces the cost, time, and internal effort required to validate the new QMS.

    Pharma teams avoid duplicate validation work, shorten deployment timelines, and minimize operational disruption.

    Does Scilife support data migration from legacy systems? And how long does data migration take?

    Yes. Scilife supports migration from legacy QMS tools, shared drives, and partially digital systems. Our team guides customers through extraction, formatting, validation, and upload to maintain data integrity throughout the process. Data migration duration depends on data volume and structure, but it’s typically handled during the 90-day onboarding period.