QMS

Labii's Risk Assessment module is a comprehensive, structured platform within the Labii Quality Management System (QMS), purpose-built for research, manufacturing, and compliance teams in life sciences, pharmaceuticals, and other regulated industries. It empowers organizations to identify, evaluate, and mitigate risks through a structured, auditable, and repeatable process—eliminating the need for error-prone spreadsheets and replacing them with a fully traceable digital environment.

Designed to support frameworks such as ISO 14971, HACCP, and ICH Q9, Labii's Risk Assessment adapts to diverse regulatory requirements while maintaining complete traceability across all risk activities. Its AI-integrated, modular architecture allows teams to manage everything from hazard analyses to risk control evidence within a single unified workspace.

Centralized Risk Documentation and Control

• Provides a unified workspace to manage risk registers, hazard analyses, and mitigation strategies.
• Supports multiple regulatory frameworks including ISO 14971, HACCP, and ICH Q9.
• Maintains full traceability across all risk documentation and decisions.

Customizable Risk Templates and Workflows

• Offers pre-built templates as well as the ability to create custom risk models.
• Configurable matrices, thresholds, categories, and evaluation rules to match organizational SOPs.
• Modular system design aligns with quality system requirements across different industries.

Quantitative and Qualitative Risk Analysis

• Score risks by severity, likelihood, and detectability.
• Automatically calculates Risk Priority Numbers (RPNs) for each identified risk.
• Presents results through intuitive dashboards and heatmaps to simplify prioritization and follow-up.

Built-In Data Table Structure for Full Traceability

• Risk Assessment – The master record tying together a complete risk review or evaluation, representing a device, process, system, or product under assessment.
• Risk – Individual risk items identified within a given assessment, including severity, probability, and detectability scores.
• Risk Control – Captures preventive or corrective actions taken to reduce risk, including effectiveness, type (e.g., design or procedural), and residual risk outcomes.
• Risk Standard – A reference table of regulatory or internal standards used as guidance (e.g., ISO 14971, ICH Q9), ensuring alignment with best practices.
• Risk Component – Breaks down assessments by sub-systems, components, or process steps, supporting modularity and reuse across multiple assessments.
• Risk Test – Records verification or validation activities used to confirm the effectiveness of risk controls, providing documented evidence for audits.

Collaboration and Access Control

• Enables cross-functional teams to collaborate securely on risk assessments.
• Role-based access control ensures appropriate permissions across team members.
• Threaded comments and full version history support traceable decision-making.

Integration with ELN, LIMS, and QMS

• Associates risks directly with experiments, production runs, deviations, CAPAs, and SOPs.
• Interconnected platform embeds risk awareness across scientific and operational workflows.
• Seamlessly links with Labii's Electronic Lab Notebook (ELN), Laboratory Information Management System (LIMS), and broader QMS modules.

Regulatory Compliance Capabilities

• Built-in audit trails and digital signatures support compliance in regulated environments.
• Compliance-ready reporting maps each risk to controls, standards, and verification tests.
• Designed to satisfy ISO, FDA, and GxP requirements out of the box.

Labii's Risk Assessment is available as part of the broader Labii platform, which is deployed as a SaaS solution with top-tier security and data center infrastructure. It is suitable for biotech and pharmaceutical companies, contract research organizations (CROs), and other regulated industries seeking a scalable, audit-ready risk management solution that integrates natively with their existing laboratory and quality workflows.