Enterprise Quality Management Software

 In the highly regulated world of medical device manufacturing, even the smallest product deviation can lead to life-threatening consequences, costly recalls, or failed audits. With the FDA, ISO 13485, and MDR regulations tightening, medical device companies need more than spreadsheets or legacy systems—they need intelligent, regulatory-compliant nonconformance management software . What is Nonconformance Software? Nonconformance software is a digital solution that helps medical device manufacturers detect, document, manage, and resolve deviations from product or process specifications. From identifying issues on the shop floor to tracing corrective actions, this software forms the backbone of a robust quality management system (QMS). For medical device companies, it’s essential that the software supports compliance with: FDA 21 CFR Part 820 (QSR) ISO 13485:2016 EU MDR 2017/745 21 CFR Part 11 for electronic signatures and records Why Manual Systems Are a Liabilit...

  Qualityze Nonconformance Management Software is purpose-built to help organizations align with ISO standards such as ISO 9001, ISO 13485, and ISO/TS 16949. The software provides a structured framework to capture, investigate, and resolve nonconformances in a consistent and compliant manner. It ensures that all quality issues are properly documented, analyzed, and linked to appropriate corrective actions, supporting ISO’s core principles of quality assurance and continuous improvement. Maintaining detailed records is critical for ISO compliance. Qualityze automates the documentation process, capturing essential data such as nonconformance descriptions, root causes, risk evaluations, and resolutions. The system maintains complete traceability with secure audit trails and version control, ensuring that organizations can easily demonstrate compliance during audits and inspections. It also supports electronic signatures to meet FDA 21 CFR Part 11 requirements when applicable. ISO...

  Qualityze CAPA Management Software provides a robust and closed-loop system to manage corrective and preventive actions effectively. It enables organizations to systematically identify, investigate, and resolve quality issues to avoid recurrence and noncompliance. The platform supports both proactive and reactive CAPAs, ensuring quality improvement across all functions. One of the core strengths of Qualityze CAPA Software is its built-in risk management functionality. Before initiating a CAPA, users can conduct risk assessments to evaluate the severity, likelihood, and potential impact of an issue. This helps prioritize actions and resources toward high-risk areas, supporting a risk-based quality approach aligned with ISO and FDA expectations. The software incorporates industry-standard tools such as 5 Whys and Fishbone diagrams to assist in identifying the root causes of problems. Once causes are established, users can create detailed corrective and preventive action plans....

Enterprise Document Management Software : Qualityze Enterprise Document Management Software is designed to help large organizations manage, control, and secure critical documents across departments, sites, and teams. Built on the robust Salesforce platform, it offers centralized access to policies, procedures, SOPs, and records in a highly secure and compliant environment. The software supports collaboration across global teams, enabling consistent document practices and standardization across the enterprise.

  Qualityze Maintenance Management Software is a cloud-based solution designed to streamline and automate maintenance activities across an organization. Whether it’s preventive, corrective, or predictive maintenance, the platform ensures equipment is maintained efficiently and consistently. It helps businesses reduce downtime, extend asset life, and maintain operational reliability by managing work orders, service histories, parts inventories, and technician assignments—all from a centralized system. One of the key strengths of Qualityze EQMS Suite is its ability to automate preventive maintenance schedules based on time, usage, or performance indicators. The software also supports predictive maintenance by using real-time data and analytics to anticipate equipment issues before they become critical. These capabilities help reduce unexpected failures, optimize maintenance cycles, and control costs associated with reactive maintenance efforts. Built on the Salesforce platform,...

  Qualityze Document Management Software with OCR is a next-generation, cloud-based solution that enables organizations to efficiently capture, manage, and search documents—both digital and scanned—by converting them into fully searchable, editable content. Built on the secure Salesforce platform, the software supports advanced OCR technology to extract text from scanned images, PDFs, and other non-editable file formats, significantly improving document accessibility, compliance, and operational efficiency. With OCR functionality, Qualityze enables users to digitize paper-based documents , such as historical records, regulatory filings, batch production sheets, and signed contracts, making them easily retrievable through keyword searches or metadata filters. This eliminates the need for manual data entry and allows organizations to index vast amounts of legacy documentation with accuracy and speed. The software supports full document lifecycle management —from creation and appro...