QMS

The Quality Management Software (QMS) by Sercle Software aims to assist businesses in managing and enhancing their quality processes and compliance with industry standards such as ISO 9001, ISO 13485, ISO 17025, FDA, GMP, and BRC. This software solution is designed for small to large-sized companies across various industries and is commonly used by quality managers, compliance officers, process owners, manufacturing and production companies, healthcare and pharmaceutical industries, food and beverage industries, forensics and testing laboratories, as well as logistics and distribution companies.

Key Features

Quality Driven Dashboards: According to the vendor, the QMS provides a dashboard that displays key attributes such as the number of non-conformances raised, common fault and cause categories, overdue actions (CAPA's), upcoming internal audits, and progress on specific tasks. Pre-set dashboards enable real-time monitoring of issues across departments and facilitate effective response with corrective actions. Additionally, users can create custom dashboards tailored to different job functions, reducing information overload.

Task Automation and Follow-Through: The QMS includes a task notification system with reminders and deadlines to ensure efficient management of the ISO quality management system. The vendor claims that users can customize deadlines, reminders, and escalation processes based on their preferences. The advanced notification functionality sends notifications to relevant stakeholders based on logic, aiming to ensure the delivery of pertinent information.

Security and Traceability: The QMS offers two-factor authentication options, including username/passwords, mobile authentication, email authentication, and biometrics. The vendor states that the software complies with FDA CFR Part 11A for pharmaceutical and medical devices industries, ensuring the capability of digital signatures to the required standard. The QMS tracks actions completed by users, including the time of action and a description, providing traceability and accountability. Furthermore, it enables digital signatures for important tasks such as final sign-off or implementation, aiming to ensure compliance and security.

Out of the Box Processes with the EQMS: The QMS provides out-of-the-box processes for key quality management areas such as document control, audits, change control, calibration, CAPA, and non-conformance. According to the vendor, these processes can be easily customized to meet specific company requirements, reducing the need for extensive mapping and configuration.

Document Management & Control: The QMS offers a formal version control process, read and understood features, archive, history, and audit logs, easy assessment and distribution, and the ability to link documents to all processes.

Audit Management: The QMS supports scheduled audits and adhoc audits, provides audit checklists, tracks actions, and manages ownership.

CAPA: According to the vendor, the QMS allows for linking CAPA to multiple processes, provides reminders to complete tasks, and keeps track of corrective and preventative actions consistently raised.

Non-Conformances: The QMS enables recording of non-conformances, workflow with logic rules, uploading attachments and images, assigning tasks to users, and linking non-conformances to CAPA.

Customer Complaints: The QMS offers a formal process to make changes to product or processes, multi-team approvals, team reminders, and implementation tracking.

Supplier Vendor Management: The QMS supports supplier approvals, automated supplier yearly reviews, and supplier corrective action reports (SCARs).