NOVA-QMS

NOVA-QMS is a comprehensive, integrated quality management system (QMS) developed by Novatek International for regulated industries including pharmaceutical, biotechnology, and life sciences. Designed to replace paper-based forms, disconnected databases, and manual processes, NOVA-QMS centralises and integrates all quality processes into a single, web-based platform that supports compliance with 21 CFR Parts 11, 210, and 211, ISO standards, and FDA's Quality Systems Approach to Pharmaceutical CGMP Regulations. Hundreds of pharmaceutical and biotechnology companies rely on Novatek software to ensure compliance, improve product quality, and reduce operational costs.

NOVA-QMS addresses the full spectrum of quality management challenges faced by manufacturers, contract research organisations, and lab services organisations. Its fully configurable and scalable architecture allows organisations to deploy the entire integrated solution or individual modules, adapting fields, forms, workflows, and business rules to specific business needs without custom software development. The system integrates seamlessly with ERP platforms such as SAP, JDE, and Oracle, as well as Document Management, LIMS, and MES systems.

Key Features and Benefits

• Ensures compliance with 21 CFR Part 11, 21 CFR Parts 210 and 211, and ISO standards
• Implements a closed-loop quality system consistent with FDA guidance and industry best practices
• Maintains high quality levels across outsourced sites and supply chain partners
• Reduces costs associated with reworks, scrap, and process downtime
• Increases product quality and supports brand equity enhancement
• Reduces cycle time and accelerates time to market
• Automates workflow and enforces configurable business rules to ensure process adherence
• Eliminates risks associated with manual and paper-based processes
• Provides robust reporting and trending tools to support data-driven decision-making
• Delivers proven return on investment

Deviation, OOS, and Investigation Management

NOVA-QMS enables organisations to record, assess, and investigate deviations, out-of-specification (OOS) results, errors, and other quality events in a centralised system. Automated workflow ensures zero missing deviations, improves impact assessment, and reduces deviation cycle time. Integration with ERP and MES systems streamlines batch release without requiring software customisation, while consistent root cause analysis processes reduce the likelihood of repeat problems.

Customer Complaint Management

• Centralises complaint intake from call centres, distributors, sales, and quality management functions
• Integrates with ERP systems for direct look-up and linking to master product information
• Manages adverse event reporting and supports consolidated reporting to health authorities
• Automates workflow for investigations, root cause analysis, and escalation of significant or overdue complaints
• Supports response letters and barcode label printing and reading

Audit Management

NOVA-QMS supports the full lifecycle management of all audit types, including GMP/GLP/GCP, internal quality audits, supplier and contractor audits, regulatory inspections, risk assessments, computer system validation audits, EH&S audits, and more. The system's Audit Manager standardises audits through online questionnaires and templates, performs scoring, and allows audit team members to download assigned audits for offline documentation. Automated workflow covers scheduling, preparation, auditing, report approval, report issuance, response, and corrective action tracking, with audit reports generated directly from the system.

Change Control

• Manages all types of change in a single centralised system, including equipment, process, batch/material/part, documents (SOPs, protocols), computer systems, supplier changes, emergency changes, labelling and packaging, EH&S changes, utilities, and validation
• Enforces standardised change control procedures while allowing workflow flexibility based on change type
• Routes records through impact assessment, review, approval, and implementation stages automatically
• Notifies appropriate parties, assigns tasks, and schedules approvals based on change type, impact, and priority
• Integrates with ERP, equipment inventory, MES, and document management systems
• Manages all related tasks including regulatory notifications, post-implementation actions such as stability studies, and effectiveness checks

Corrective and Preventive Action (CAPA)

NOVA-QMS serves as the central hub of the quality management system for CAPA management, supporting FDA, ISO, EMEA, and other regulatory requirements. The system manages CAPAs originating from any source, assigns investigation tasks to team members via personalised dashboards, and facilitates collaborative root cause analysis using drill-down selection tools. Electronic workflow controls CAPA plan development, approval, implementation, verification, and effectiveness checks. The system monitors key milestone dates, escalates latent issues based on configurable conditional logic, and provides integrated reporting and trending tools to support GMP decision-making.

Training Management

NOVA-QMS includes training management capabilities as an integral component of the overall quality management system, helping organisations ensure employees are appropriately trained and reducing the labour-intensive and error-prone nature of manual training administration.

NOVA-QMS is delivered as a fully configurable, scalable platform suitable for single-site and multi-site deployments. Its open integration architecture supports connections to leading ERP, LIMS, MES, and document management systems, enabling organisations to build a harmonised, enterprise-wide quality management infrastructure that meets the expectations of global regulatory bodies and health authorities.