Pharma QMS software is the smart way forward for pharmaceutical companies aiming to stay compliant, agile, and quality-driven in a highly regulated industry. With AURA’s intelligent platform, you’re not just managing quality—you’re transforming it. From automated workflows to real-time insights, our solution helps you stay audit-ready, reduce risk, and scale with confidence.
Ready to modernize your quality management approach?
Let’s connect. Book a free demo and explore how AURA’s Pharma QMS software can elevate your compliance game and streamline your operations—end to end.
The essential components and procedures of a pharmaceutical quality management system (QMS):
A well-structured pharmaceutical QMS is essential for ensuring regulatory compliance, maintaining product quality, and driving continuous improvement in pharmaceutical operations. Below are the core processes and elements that form the backbone of a compliant and efficient quality management system in the pharmaceutical industry:
- Pharmaceutical Document Control: Manages the lifecycle of controlled documents—including creation, approval, distribution, revision, and archival—ensuring version control and compliance with GMP requirements.
- Change Management: Oversees the controlled implementation of changes across processes, systems, equipment, and documentation, ensuring all modifications are risk-assessed and properly approved before rollout.
- Training Management in Pharmaceuticals: Identifies training needs, delivers relevant programs, and evaluates effectiveness to ensure personnel are competent and compliant with industry standards.
- Deviation Management: Handles the systematic recording, investigation, and closure of unplanned events or non-conformances, ensuring root cause analysis and timely resolutions are in place.
- Pharmaceutical Complaint Management: Captures, logs, and investigates customer complaints to identify quality issues and initiate appropriate corrective measures.
- CAPA Management: Facilitates root cause analysis and implements corrective and preventive actions for issues arising from deviations, non-conformances, complaints, or audit findings.
- Audit Management in Pharmaceuticals: Manages internal, external, and supplier audits with complete tracking of findings, corrective actions, and timely closures—ensuring audit readiness at all times.
- Supplier Quality Management: Ensures supplier qualification, risk assessment, and ongoing monitoring to maintain quality standards.
- Equipment and Calibration Management: Covers preventive maintenance, calibration, validation (IQ/OQ/PQ), and qualification of equipment to ensure reliable and compliant operations.
- Product Lifecycle Management: Manages pharmaceutical products from development through distribution—including batch review, quality control testing, storage, final release, and CoA documentation.
- Management Review of QMS: Enables senior leadership to review QMS performance through KPIs, audit outcomes, CAPAs, deviations, and risk assessments—driving continuous improvement.
Key Challenges in the Pharma Industry
Benefits of the Pharma QMS software:
Implementing AURA’s pharmaceutical quality management software delivers measurable value:
Key Highlights of AURA’s Pharma QMS Software
- System Validation
- Document Migration
- Cloud Hosting
- Seamless Implementation
- User Training
- Unlimited Support
- All QMS Modules Included
- And much more…
AURA’s Pharma Quality Management and QMS software provides tailored solutions to address the specific challenges faced by the pharmaceutical industry—ensuring compliance, enhancing operational workflows, and maintaining the highest quality standards.
Ready to Modernise Your Quality Management Approach?
Let’s connect. Book a free demo and see how AURA’s Pharma QMS software can elevate your quality strategy, strengthen compliance, and accelerate operational excellence—end to end.
