by nuna.digital

Scilife

Offers a comprehensive quality management system for life sciences, automating processes, ensuring compliance, and enhancing team collaboration.

Overview

Scilife provides a comprehensive quality management system designed to automate processes and ensure compliance in the life sciences sector. The platform facilitates seamless end-to-end traceability and data integrity within workflows.

Teams are empowered with a quality-first mindset, fostering collaboration and shared ownership of quality initiatives. Scilife's system supports digitalization of document and record management and automates compliance training.

Key features include:

Audit readiness and management of CAPAs, deviations, and nonconformities.
Integration of change control and risk assessments for comprehensive quality oversight.
Quality metrics to enhance performance and achieve KPIs.
Version control and automatic linking of risk assessments.
Compliance with ISO 13485 and FDA 21 CFR 11 standards.

The platform accelerates time-to-market by up to 35% by eliminating confusion in design and development workflows. It also ensures flawless audits and easy tracking by integrating essential apps.

Scilife prioritizes data security, employing stringent measures across product and infrastructure to maintain data safety and compliance. Unique barcodes and traceability features speed up reconciliation processes and allow quick action on missing documents.

With offices in Brussels and New York, Scilife is committed to transforming life sciences teams into quality boosters.

Tools

Audit Management

Centralizes documents, automates processes, and ensures compliance for seamless audit readiness in life sciences.

Software for managing supplier qualifications, audits, and findings in life sciences, integrating with other modules for seamless information access.

CAPA Management

Software to manage Corrective and Preventive Actions (CAPAs) efficiently, ensuring compliance and streamlined workflows.

Change Control module

Software for managing change requests, approvals, and implementations, fostering company-wide participation in modifications.

Design and Development tool

Medical device development software that streamlines traceability, accelerates audit readiness, and ensures compliance with ISO 13485:2016 and FDA 21 CFR 820.

Centralizes design control documentation for medical devices, ensuring compliance with ISO 13485 and 21 CFR part 820 through structured workflows and automated traceability.

Document Control

Centralized document management system for efficient operations, integrating with MS Office and automating essential tasks.

Equipment Management

Software for managing equipment qualification, maintenance, and calibration tasks with simple workflows and inspection readiness.

Software for managing deviations and nonconformities in life sciences, enabling quick event registration and streamlined follow-up actions.

Print and Reconciliation

Software ensuring FDA 21 CFR 11 compliance by controlling printing and reconciliation, tagging each page for easy identification and retrieval.

Software for managing medical device quality, ensuring compliance with ISO 13485 and FDA 21 CFR 820, and streamlining design controls and documentation.

Quality KPI software

Track and visualize quality KPIs to improve decision-making and compliance in life sciences.

Risk Assessments

A user-friendly platform for managing risk assessments, integrating with other processes, and ensuring timely reviews.

Digital solution for managing quality processes, ensuring compliance, and driving continuous improvement in life sciences organizations.

Training Management

Software for managing employee training in life sciences, ensuring compliance and efficiency with automated notifications and customizable training plans.

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