softQMS

SoftQMS is a modular Quality Management System (QMS) software solution by PharmaSoft Solutions designed for regulated industries (like pharmaceuticals) to ensure compliance, process control, traceability, and continuous improvement. The system is built to cover the full lifecycle of quality events in an organization, integrating modules for change control, deviations/non-conformances, CAPA, investigations, management change (MC), vendor qualification, incidents, audit management, and risk assessment.

The goal of SoftQMS is to provide a comprehensive platform that captures all quality-related events, ensures they're properly evaluated, investigated, corrected/prevented, tracked, and reported. Also, workflows are structured so as to comply with regulatory and industry standards (GMP, ISO etc.).

Overview of the Modules

Below is a module-wise breakdown, including features and typical workflows.

Change Management or Change Control:

SoftQMS Change Management module ensures every change in process, system, equipment, or documentation is properly evaluated, approved, and implemented. With structured workflows, it captures proposed changes, performs impact assessments, routes for stakeholder approvals, and verifies effectiveness after implementation. This helps organizations maintain compliance while minimizing unintended risks from changes.

Deviation/Non-Conformance:

The Deviation module enables seamless recording and management of process or product deviations. It supports deviation classification, root-cause analysis, investigation, and closure with corrective actions. By linking with CAPA, the system ensures deviations are resolved and preventive measures are applied to avoid recurrence.

Corrective Action & Preventive Action:

The CAPA module strengthens continuous improvement by managing both corrective and preventive measures. Users can initiate CAPA directly from deviations, audits, incidents, or investigations, define action plans, assign responsibilities, and track progress. Integrated verification ensures actions are effective before closure.

Investigation:

SoftQMS Investigation module provides a structured approach to root-cause analysis. It supports evidence gathering with required lists, and documentation of findings. Linked with deviations and CAPA, this module ensures quality issues are addressed systematically with corrective actions and preventive strategies.

Vendor Management:

This module ensures suppliers and contractors meet required quality and compliance standards. It supports vendor registration, risk assessments, audits, approval workflows, ongoing performance monitoring, and re-qualification. By controlling vendor quality, organizations strengthen their supply chain and reduce compliance risks.

Audit Management:

SoftQMS Audit Management simplifies internal and external audit planning, execution, and follow-up. It allows scheduling, capturing observations, classifying findings, and linking them to CAPA. Progress tracking and effectiveness checks ensure audit observations are addressed and closed on time, improving readiness for regulatory inspections.

Incident Management:

The Incident module helps record, investigate, and resolve unexpected quality or safety events. Incidents are tracked through detailed workflows including investigation, corrective actions, preventive measures, and closure. Linked with CAPA, the module ensures incidents are not only resolved but also prevented in the future.

Risk Assessment:

The Risk Assessment module integrates risk-based thinking across the QMS. It supports identification of risks, likelihood and impact scoring, prioritization, mitigation planning, and continuous monitoring. Risks can be linked to changes, deviations, audits, and vendor qualification, enabling proactive quality decisions.

softQMS - Advantages: