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Manufacturers worldwide, especially in regulated industries, must ensure products are handled properly throughout production. Qualityze Batch Record Management helps businesses maintain compliance with regulations like CGMP by managing essential production records, such as materials, equipment, and inspections. This cloud-based solution helps manufacturers improve accuracy, detect errors early, and reduce costs. By integrating with existing systems, Qualityze automates data capture, minimizes paper usage, and boosts operational efficiency, enabling companies to scale globally while consistently producing high-quality products.
Manufacturers worldwide, especially in regulated industries, must ensure products are handled properly throughout production. Qualityze Batch Record Management helps businesses maintain compliance with regulations like CGMP by managing essential production records, such as materials, equipment, and inspections. This cloud-based solution helps manufacturers improve accuracy, detect errors early, and reduce costs. By integrating with existing systems, Qualityze automates data capture, minimizes paper usage, and boosts operational efficiency, enabling companies to scale globally while consistently producing high-quality products.
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Contact UsQualityze Batch Record Management System has features like configurable EBR forms, a centralized batch record database, and inventory management tools. With configurable forms, you can create custom electronic batch records, like Blend Production Records and Process Checklists, to collect consistent data during production. The centralized batch record database keeps all records in one place, making it easy to track and meet regulatory standards.
The Decision QAI Assistant analyzes production batch records to identify patterns, trends, and insights. This helps you find ways to improve, prevent recurring issues, and make better decisions.
Qualityze Batch Record Management System makes sure records follow industry standards by keeping a detailed audit trail for each record. It logs every activity, such as form names, bulk orders, and inspections, with timestamps and user details. This makes sure that records are traceable and easy to access during audits. The system also uses electronic signature validation to keep records safe and authentic, meeting standards like FDA 21 CFR Part 11 and GMP.
Qualityze Batch Record Management System has tools for tracking equipment and inventory. It monitors equipment health, such as calibrations and maintenance schedules, to make sure they are ready when needed. It also keeps track of materials used in production, including expiration dates and quality, to prevent problems. By managing line/room clearance activities, it also helps reduce the risk of contamination. These features work together to reduce downtime and keep production running smoothly.
Qualityze has several tools to help teams work better. Pre-defined EBR form templates make sure that data is collected consistently. The task scheduler helps users assign and keep track of tasks in advance, reducing mistakes. The Chatter feature allows real-time messaging, so team members can solve issues quickly. Automated approval workflows keep everyone informed about pending tasks, and electronic signatures help secure the approval process.
Qualityze uses multiple security features to protect electronic batch records. Access controls make sure that only authorized people can access the records, based on their roles. Data is encrypted both when stored and during transmission, keeping it safe from unauthorized access. Qualityze also has integrated reporting to track changes, making sure data stays secure and intact.
Qualityze allows users to create different reports, providing insights into production trends, equipment health, inventory, and more. These reports help you identify problems, improve quality control, and meet compliance requirements. For example, reports can show where equipment needs maintenance or where there are inventory discrepancies. These insights make it easier to pass audits and fix issues quickly.
Yes, Qualityze Batch Record Management System can connect with other systems like ERP (Enterprise Resource Planning), CRM (Customer Relationship Management), and EQMS (Enterprise Quality Management System). This integration makes it easier to manage production, quality, and compliance by having everything in one workflow. It reduces manual data entry, prevents errors, and makes sure all data is up to date, leading to better decision-making and efficiency.
Qualityze gives each user personalized dashboards, showing real-time updates on tasks, reviews, and approvals. This helps users focus on critical tasks and meet production goals on time. Features like electronic signature validation and alerts make sure everyone stays informed and engaged in the process, keeps everything compliant with less effort.
