Scilife provides Smart QMS, a cloud‑native electronic Quality Management System for regulated life‑science companies. The platform digitizes document control, CAPA, change control, risk assessment, audits and design‑development workflows, delivering real‑time traceability, 21 CFR Part 11‑compliant e‑signatures and built‑in analytics. Integrated with AWS security and API connectors, it reduces manual effort and keeps organizations audit‑ready.
Funding
Funding not disclosed
Founders
Product
Problem
Life sciences companies rely on manual, paper‑based quality processes that are fragmented across departments, leading to inconsistent data, high error rates, difficulty maintaining regulatory compliance (GMP, ISO 13485, 21 CFR Part 11), and time‑consuming audit preparation.
Solution
Scilife delivers a cloud‑native electronic Quality Management System (eQMS) called Smart QMS that digitizes and automates core quality functions—including document control, CAPA, change control, risk assessment, audits, training, and design‑development workflows. The platform provides real‑time traceability, electronic signatures, and built‑in analytics to monitor key performance indicators. Integrated modules share data automatically, enabling audit‑ready documentation and reducing manual effort. Security is ensured through AWS‑hosted, encrypted, multi‑tenant infrastructure with regular backups and role‑based access controls.
Target Audience
Primary users are regulated life‑science organizations—pharmaceutical and biotech firms, medical‑device manufacturers, CRO/CMO providers, ATMP producers, and medicinal‑cannabis companies—who need a unified, compliant quality management platform.
Features
- Centralized document management with version control, 21 CFR Part 11‑compliant e‑signatures, and live editing via Microsoft Office integration.
- Automated CAPA lifecycle: template‑driven creation, configurable approval routing, automated notifications, and linkage to change control and audit records.
- Change control module that tracks revisions, enforces approval hierarchies, and connects directly to related CAPAs and risk items.
- Risk assessment tool with customizable scoring, periodic review scheduling, and automatic risk‑score calculation.
- Audit management dashboard that generates audit trails, links findings to CAPAs and changes, and supports supplier, internal, and regulatory audits.
- Quality KPI suite offering out‑of‑the‑box dashboards, trend analytics, industry benchmarking, and one‑click CSV export.
- Design & Development traceability matrix that auto‑links user needs, design inputs, outputs, verifications, and validations, with version comparison and report export.
- Controlled printing and reconciliation feature with barcode tracking, 21 CFR Part 11 compliance, and automated reprint alerts.
- RESTful API and pre‑built integrations (e.g., Active Directory, Azure AD) for seamless data exchange with ERP, LIMS, or other enterprise systems.
- Enterprise‑grade security: AWS VPC isolation, end‑to‑end encryption, automated backups, and GAMP‑5 validated SaaS environment.