SOLABS QM10

SOLABS QM10 is an Electronic Quality Management System (EQMS) designed for life sciences organizations. It consolidates document management, training records, audit management, task tracking, and additional quality processes into a single validated platform. The system is structured around three offering configurations — Fundamentals, Enterprise, and Managed — intended to support organizations at different stages of growth, from those establishing foundational quality processes to those managing complex, global operations.

All three configurations share a core set of features, with Enterprise and Managed tiers offering additional optional modules and expanded client success support. QM APPs covering processes such as CAPA, Change Control, Deviations, Laboratory Investigations, and Product Complaints can be added at any time across all tiers.

Offering Configurations

• Fundamentals: Includes Document Management, Audit Management, Task Management, Integrated Reporting, Training Records Management, and a Validation Package as standard. Single Sign-On, Collaborative Review with Office 365, and Dataset Exports are optional. All five QM APPs (CAPA, Change Control, Deviations, Laboratory Investigations, Product Complaints) are included. Client Success Assistance includes 2 hours and Level II Support is provided.
• Enterprise: Includes the same core features as Fundamentals, with the Validation Package listed as optional. All five QM APPs are available as optional add-ons. Client Success Assistance includes 5 hours and Level II Support is provided.
• Managed: Mirrors the Enterprise configuration in terms of features and optional modules. Also includes 5 hours of Client Success Assistance and Level II Support, with the addition of Quality System MVP managed services.

Document Management

• Provides a structured library for storing, managing, and accessing controlled documents.
• Supports the full document lifecycle: creation, review, approval, revision, and retirement within a controlled framework.
• Every action is recorded with electronic signatures, timestamps, and audit trails to support regulatory traceability.
• A dedicated Document Control process allows multiple documents to be circulated and approved together, supporting large-scale change management.

Audit Management

• Supports planning, execution, and closure of internal, external, and regulatory audits within the platform.
• Covers the full audit lifecycle: Audit Planning, Audit Preparation, Audit Activities, Preparation and Issuance of Audit Report, Audit Report Response, Completion of Commitments, and Audit Closure.
• Includes scheduling, auditor assignment, findings documentation, response management, and corrective action tracking through to verified closure.

Task Management

• Allows creation, assignment, and monitoring of tasks originating within QM10 or externally.
• Tasks can be linked to audits, documents, or other quality processes to provide visibility into broader objectives.
• Users can view pending tasks, sign off on completion, and maintain a full audit trail of all actions.

Training Records Management

• Centralizes all employee training activities within a validated environment.
• Provides visibility into training status by employee, department, or role.
• Tracks who is trained, who is overdue, and where compliance risks may be emerging.
• Training workflows can be configured to match organizational structure and regulatory requirements.
• Includes an Online Assessment Interface for creating and delivering tests directly within QM10, documenting both training completion and demonstrated competency.

Integrated Reporting and Analytics

• Provides real-time reporting across all functional areas, including document status, training compliance, and quality processes.
• Supports configurable dashboards and detailed reports that can be filtered and exported.
• Standard reports are included; custom reports can be created on demand.
• Reports can be exported to Microsoft Word, Excel, or PowerPoint, and shared by email.

Validation Package

• Includes pre-executed validation tests performed by SOLABS.
• Provides a complete validation documentation package, including Validation Plan, Protocols, and Reports.
• Supports optional User Acceptance Testing (UAT) based on client requirements.
• Validation is maintained through every system upgrade to keep the platform in a validated state throughout its lifecycle.

Single Sign-On and Authentication

• Supports SSO integration through Microsoft Azure Active Directory and OneLogin using SAML 2.0 and OAuth 2.0 protocols.
• When SSO is enabled, users authenticate with their Microsoft or OneLogin credentials, and password policies are governed by corporate IT standards.
• Multi-Factor Authentication (MFA) can be enforced, with re-authentication prompts triggered from within QM10.
• External users such as manufacturers, vendors, clients, or auditors can be granted secure access through centralized identity management.

Microsoft Office and SharePoint Integration

• Integrates with Microsoft Office Online to enable real-time collaborative editing of controlled documents without downloading local copies.
• All changes are captured within the validated system.
• An automatic version-to-version compare feature allows Document Coordinators to identify updates between document revisions, reducing the risk of human error during review and approval cycles.

Dataset Exports

• Exposes all system data through a set of structured datasets using industry-standard ETL processes.
• Datasets can be exported daily to support client data lakes or private AI infrastructures.
• Supports data sharing with external systems and advanced analysis outside the platform.

QM APPs — Additional Quality Processes

• CAPA: Links corrective and preventive actions to audits, deviations, documents, and training for full traceability and compliance.
• Change Control: Offers predefined process options (Option A and Option B) that clients select during implementation to ensure a consistent, repeatable change control process.
• Deviations: Centralizes deviation tracking and links each issue to related CAPAs, audits, documents, and training.
• Laboratory Investigations: Provides a dedicated QM APP for documenting laboratory investigations.
• Product Complaints: Manages pharmaceutical product complaints by connecting each case to related CAPAs, audits, and documents.

• Each quality process is assigned a unique ID and can be linked to documents and secondary tasks.
• All processes maintain a complete audit trail recording all actions and changes.
• Printable and exportable summaries are available for sharing with auditors, vendors, or other stakeholders.
• Additional QM APPs can be purchased and deployed at any time.

Managed Services — Quality System MVPs

• Quality System MVPs are industry-certified experts with knowledge in QM10 configuration and administration, as well as life sciences quality management and validation best practices.
• They support system performance optimization, compliance maintenance, and continuous improvement.
• Available as an alternative to a full-time employee for ongoing system management, maintenance, and strategic evolution.

Client Support

• Level II Support: Unlimited access to the SOLABS technical team for handling errors or unexpected system behavior that Super Users cannot resolve.
• Client Success Assistance (CSA): A bank of hours (2 hours for Fundamentals, 5 hours for Enterprise and Managed) available on demand for training, technical guidance, software operation assistance, and data migration support.

SOLABS QM10 is a cloud-hosted, validated platform with headquarters in Brossard, Quebec,