eQMS | Quality Management System for Laboratories

Manage and control the entire documentation lifecycle, including version control, remote access, and management of copies and obsolete files. Optionally integrates with collaborative editing tools like SharePoint or Google Workspace.

Define, assign, and track training and courses for personnel linked to the QMS. Integration with the DMS allows for direct training on SOPs and current documentation, ensuring compliance with GMP regulations.

Define and plan corrective, preventive, and improvement actions stemming from deviations, complaints, audits, or other processes. Each action is traced back to its root finding and remains open until its effectiveness has been verified.

Identify, investigate, and manage quality deviations in a structured manner, with clearly defined owners and approvers. Close out issues by linking them to the corresponding CAPAs, ensuring complete process traceability.

Plan, execute, and document internal and external audits by defining scope and responsibilities from a single platform. Detected findings integrate directly with the CAPA module for tracking through to closure.

Manage and document the entire change lifecycle, from request submission to implementation. Collaborative work between defined roles ensures review, approval, and traceability at every stage of the process.

Centralize the logging, investigation, and analysis of quality claims. When a claim leads to a non-conformance, it automatically integrates with the Non-Conformance module, managing both the non-conformance and its associated CAPAs in one place.

Identify, assess, and manage risks, verifying the effectiveness of actions through re-evaluation. Facilitate proactive decision-making and task tracking by owner, in alignment with ISO 31000, FMEA, and ICH Q9.

Manage strategic partners and suppliers, from onboarding and evaluation for approval to periodic performance monitoring using configurable criteria. Automatically generate action plans when results require them, with reporting and notifications for all stakeholders.

Schedule any activity related to the QMS, such as annual audit plans, calibrations, or maintenance, by detailing dates and assigned personnel. The alert system automatically notifies you of assigned or pending activities.

Manage the entire product recall process, from initial detection to execution and final closure. Classify severity, define the scope (affected batches, markets, and customers), coordinate notifications to authorities and stakeholders, and track the effectiveness of all actions taken.