Qualityze Inc attends ISO 9001 and Audits World Conference, gains valuable insights on quality management and auditing!
Tampa, FL USA, 23rd March 2023: Qualityze is pleased to announce our recent participation in the ISO 9001 and Audits World Conference. The event took place on March 13-14, 2023 and brought together professionals around the globe to discuss quality management and auditing. The ISO 9001 and Audits World Conference is a premier event in […]
Qualityze Electronic Batch Record Management Solution: Enabling Enterprises to Achieve Production Excellence
Across the world, Manufacturing companies, especially those in regulated industries, must have evidence that they handled products properly during all stages of production. For example, the FDA (Food and Drug Administration) (Food and Drug Administration) ensures that a manufacturer meets the minimum requirements of Good Manufacturing Practices to ensure its products are consistently high quality, irrespective of batch size or intended use. Preparation and retention of batch records are among these requirements.
The electronic batch record contains the data and information necessary to produce a regulated product. Every business records information continuously to ensure the quality and safety of its products. In these records, data is recorded about materials, dates, equipment, people, analysis, formulating and compounding, packaging, labeling, holding and quarantine, inspections, labels, and events involved in the production process. This data provides evidence of batch traceability.
Unfortunately, businesses do not have a sound batch record management system that can efficiently identify production issues, track deviations, eliminate data inconsistencies, and much more. An effective EBR system does all this while helping you achieve production excellence and compliance.
One such system is Qualityze Electronic Batch Record Management. It helps you maintain accuracy for batch records so you can quickly identify critical production errors, data inconsistencies, equipment failure, product recalls, and much more. This cloud-based software provides you with greater visibility and traceability. It further helps you improve operational efficiency, cut production costs, and scale your operations globally for a larger market share.
Qualityze EBR Management helps you enforce standard best practices to:
- Create and manage EBR forms to collect batch production data.
- Track progress of the production processes.
- Ensure equipment effectiveness.
- Ensure compliance with training requirements.
- Verify validation and reconciliation records.
- Integrate with Enterprise Quality Systems.
EBR Management Overview
The traditional batch record management systems are meant to be stable and long-lasting, but they cannot adapt to today’s fast-paced, evolving market conditions. As a result, businesses need a more robust and integrated solution like Qualityze Electronic Batch Record Management to manage batch production records. The software is highly intuitive and configurable. Integrating the Qualityze EBR Management with the existing quality system reduces paper use and saves time and possible errors by automating data capture from production processes.
With Qualityze Electronic Batch Record Management, you can efficiently and effectively:
- Create, manage and track batch production records.
- Configure EBR forms for consistent data collection.
- Manage defects, deviations and production errors.
- Manage validation, verification, and reconciliation process.
- Streamline batch data reporting.
- Ensure regulatory compliance.
- Analyze batch data trends for intelligent decision-making.
Create and Manage EBR Forms to Collect Batch Production Data
Consistently collecting accurate batch process information requires you to standardize the data capturing sources. It would be best to have complete control of the fields you want to add in an EBR form, so you collect only the necessary information for all the batch processes. Qualityze Electronic Batch Record Management is an intuitive solution that enables enterprises to create and manage EBR forms and sub-forms without hassles. The forms and data fields are configurable to tailor the EBR form to your business and compliance requirements. Using Qualityze Electronic Batch Record Management Software, you can capture all the necessary details, such as;
- EBR Form Name
- Purchase Order
- Build Order Id
- Container Staging Location
- Packaging Type
- OQC Personnel Name
- Date and Time of Inspection
- Process Quality Technician, and much more.
Having all the critical information in a central repository gives enterprises better control of data to perform trend analysis and make informed decisions. As a result, it further improves operational efficiency and profitability. Experience the Qualityze difference to create and manage Blend Production Record, Build Order Form, In Process Quality Control Checklist, Kitting Checklist, Machine/Non-Machine Production Checklist, Order Verification Form, Outgoing Quality Control Checklist, Packaging Checklist, Product Label, and Barcode Label Confirmation, Shipping Process Checklist, and Allocation Records.
Track Progress of the Production Processes
With the Qualityze EBR Management, you can track every production process from creating an order form to a verification form, in-process quality control to outgoing quality control, process quality technicians, shifts, labeling, packaging, kitting, and more. This traceability of processes helps you avoid production failures that could lead to shipping delays, deviations, nonconformances, noncompliance, and incidents. In addition, you can use the Follow feature to monitor the progress at every level, especially if it involves addressing deviations, equipment failure, maintenance actions, design change, variable ingredient quality, and ambient conditions such as humidity or temperature.
Additionally, our software’s intuitive interface helps your employees complete their documentation, and your supervisors find data that helps them make informed decisions to improve their manufacturing processes.
Ensure Equipment Effectiveness
Manufacturers must maintain, calibrate, and repair their equipment per the requirements of regulatory bodies, such as the FDA. A smart manufacturing company will follow its internal processes and standards along with these external regulations to maximize production and minimize downtime. The benefits of preventive maintenance can be significant in terms of time and money, but tracking them can be challenging, especially when manufacturing operations are spread across multiple locations, countries, or continents. That’s what Qualityze EBR Management covers for you. You can integrate Electronic Batch Record Management with Calibration and Maintenance Management System to keep the records updated following the standard best practices. You can quickly track the calibration and maintenance actions for the equipment used. The system automatically captures and validates the activities performed to avoid downtime. By doing so, you can prevent administrative workload and productivity losses associated with updating and tracking such critical data.
With Qualityze EBR Management, you can continue to monitor equipment effectiveness to ensure smooth production processes and prevent downtime and shipping delays.
Ensure Compliance with Training Requirements
You can take a proactive approach to meet compliance training requirements by using Qualityze EBR Management. Our solution makes it possible to verify training requirements. By doing so, you can verify that an individual operator has the required training before completing the activity or signs off on the batch record – streamlining the verification process while staying in compliance with regulatory requirements. With the integration of Training Management, you can schedule training sessions ahead of time. Keeping your line employees’ training current assures them they remain eligible to perform critical manufacturing tasks.
In today’s increasingly competitive and interconnected market, manufacturing firms cannot compete unless all of their resources are utilized. Qualityze EBR Management facilitates a collaborative work environment that removes communication barriers to managing batch records and provides productive insights for all operational units.
Verify Validation and Reconciliation Records
Using digital batch records, your team can set the maximum number of valid entries. Any completed document will have validated data for your QA team to work with immediately. Data is accessible quickly. Now, you don’t need to wait hours or even days for batch record updates across your team and data to be entered into a database or repository. You can access and verify the Validation and Reconciliation data in seconds after the batch record document has been completed. It will be a massive advantage during regulatory inspections and audits when you have to produce verified and validated records.
Qualityze EBR Management also comes with effective quality reporting and corrective action capabilities, making it easier for your QA engineers to report quality events and initiate corrective actions. By doing so, you ensure that you are effectively addressing the problem from the start.
Integrate with Enterprise Quality Systems
Qualityze EBR Management comprises advanced integration capabilities to let your operational units and quality engineers better control batch records and processes. It helps establish a closed loop system with enterprise-level quality systems such as Training Management, Inspection Management, Document Management, and much more to drive excellence. You can prevent human error, data misfiling, and loss when everything is managed digitally. Furthermore, you can smoothly scale your processes across different locations without being concerned about data accessibility.
Being delivered on the Salesforce.com platform, Qualityze EBR Management ensures greater flexibility, security, and reliability to connect your business processes and achieve maximum potential.
Why EBR Management is Important?
In most cases, enterprises produce their products using batch manufacturing processes. These processes can be tailored to the manufacturer’s needs and promote quality control. In batch processes, everything is organized and documented. As a result, the electronic batch record is even more effective at reducing errors, increasing compliance, and improving efficiency. They also enhance visibility and quality throughout production processes, promote conformity with standardized process controls, and encourage conformity with standardized process controls. Digitizing your batch records can benefit you in many ways. Some of them include:
- Improved inventory and resource management, resulting in fewer material losses.
- Greater control of batch data and processes.
- Reduced production cycle time and compliance costs.
- Fewer deviations and production errors.
- Faster resolutions and response management.
- Improved productivity and scalability
- Improved bottom line.
How does Qualityze EBR Management Help Businesses?
Qualityze EBR Management helps enterprises record, manage and track batch process information. It helps them identify the production bottlenecks that can result in nonconformances, product recall compliance issues, or increased costs. By doing so, you can control the quality events and reduce the production cycle time. In addition, you can configure the EBR forms to collect validated inputs at every step. Then, you can further analyze those inputs to track trends and make intelligent decisions.
With Qualityze EBR Management, you can:
- Drive Greater Efficiency for Production Processes
- Reduce Deviations and Review Cycle Times
- Maintain Equipment History & Material Inventory
- Provides Real-Time Visibility
- Ensure Regulatory Compliance
- Securely Maintain EBR Records
Drive Greater Efficiency for Production Processes
Qualityze EBR Management System is a fully configurable solution for next-generation enterprises to manage batch record processes efficiently. Digitally filling out batch records, reviewing them, and auditing them eliminates all the hassles that could lead to production delays. For example, suppose – you have an audit going on. And your auditor picks up a batch record and demands to see all the documents and historical data associated with it. If all the records are collected manually, it will take hours, perhaps even days, to manage them in one place.
On the other hand, Qualityze EBR Management makes it a matter of a few minutes to track all the historical data relevant to the batch record. This is just one of the instances. Think of the difference a cloud-based EBR Management solution can make in managing all the production-related processes, including – quality checks, validation, documentation, reporting, and more. Are you ready to drive greater efficiency for your production processes with Qualityze EBR Management yet?
Reduce Deviations and Review Cycle Times
As we discussed above, a next-generation technology solution can drastically reduce the time your teams invest in reviewing and validating batch records. This means you will have faster review cycles, and you will be able to deliver quality goods to the market on time. But this is true for most ideal situations. What if there are variances in the purity of ingredients? If there are any power outages? If equipment is out of tolerance? Or if there is any environmental situation leading to deviations? Such factors are likely to disrupt manufacturing workflows.
Here, Qualityze EBR Management can help. In addition to accelerating the review cycle, the software provides you with better control of deviations. As a result, you can identify deviations and mitigate them in time to prevent shipment delays, product recalls, and incidents.
Maintain Equipment History & Material Inventory
Business profitability depends on gathering and processing meaningful data on equipment and materials. However, collecting data and maintaining records is not something that everyone enjoys. EBR forms should be as simple as possible, and data collection methods should be carefully thought out to ensure that they are expeditious and accurate. The record-keeping process should be made as simple and painless as possible with configurable forms and by explaining the need to everyone involved. That’s where Qualityze EBR Management Solution comes handy. Maintaining the equipment history and material inventory can help improve the decision-making process.
With the advanced integration capabilities, Qualityze EBR Management makes it easier for companies to keep track of their equipment calibration and maintenance activities. It helps you comply with the latest standards and establish best practices. On the plus side, it makes tracking calibration and maintenance actions faster than ever before, thereby maintaining equipment performance.
Provides Real-Time Visibility
Whether it is batch records, deviation data, equipment details, validation information, or reconciliation, Qualityze EBR Management provides real-time visibility into key data trends. As a result, you can quickly analyze historical records and make intelligent business decisions. The user-friendly interface and real-time visibility support your transformation journey to paperless, errorless, and frictionless EBR management. In addition, it comes with advanced reporting capabilities, so you quickly fetch the batch records in the desired format, especially during regulatory inspections and audits.
This cloud based EBR Management solution is all you need to gain real-time visibility into your production processes and manage all the inconsistencies effectively.
Ensure Regulatory Compliance
Qualityze EBR Management automatically stores all the batch records in a centralized database in a well-organized manner. Then, using a digital signature, you can validate the records at every step. This helps companies avoid human error, missing files, delays, and scalability issues. Furthermore, they can comply with FDA Part 11 regulations for managing electronic records and signatures.
Using the configurable platform, you can design the process workflows per GxP, GAMP5, ISO, and many other regulatory standards for establishing best practices in the organization. This fosters a continuous improvement culture, demonstrating your commitment to quality and operational excellence. Request a demo to experience the Qualityze difference right away.
Securely Store EBR Records
Qualityze EBR Management automatically collects all the form inputs and stores them in a central repository, ensuring better accessibility and traceability of the records. It can help change the audit and compliance game forever. You can fetch any historical data or record it in fewer minutes. The configurable forms enable you to update EBR forms per compliance requirements, such as FDA, CGMP, GAMP5, and more, with digital signature validation at every step. It reflects best practices and commitment to the culture of quality. The audit trail functionality helps you track complete details of electronic batch records. This ensures that you ask the right questions to the right person from the start to address the production issues effectively. Moreover, you can control the access of EBR forms data using advanced security tools embedded in the system. Thus, Qualityze provides a secure environment for all your data concerns.
Qualityze EBR Management – Achieving Next Level of Production Excellence Made Easier!
Qualityze EBR Management works for every industry, including – Medical Devices, Lifesciences, Pharmaceuticals, Cannabis/Hemp/CBD, Nutraceuticals, Biologics, Biotech, Manufacturing, Hospitality, Consumer Goods, Food and Beverages, Automotive, Aerospace, Defense, and Logistics. It helps them create specialized EBR forms to capture, analyze, and track batch process records. Maintaining accurate batch records translates into better decisions and production excellence. This also reflects best practices and a culture of quality your organization is committed to.
Qualityze EBR Management Solution comes with
- Centralized EBR Database
- Configurable Forms
- Pre-Defined EBR Templates
- Intuitive Dashboards
- Automated Email Approval
- Alerts and Notifications
- Seamless Integration and more.
Qualityze Electronic Batch Record Management – Drive Excellence to Manage Batch Production Records and Compliance!
A digital transformation in batch process record management requires an integrated solution connecting systems and processes to achieve production excellence. Establishing a closed-loop system provides your team with better track of every piece of information in the product lifecycle, such as raw materials from a supplier, the processes involved, customer service, equipment used, reviews, approvals, training, and much more. In addition, the end-to-end visibility helps identify data or process inconsistencies that may lead to noncompliance, deviations, or nonconforming results. Qualityze Electronic Batch Record Management enables you to handle all this and more. Using it, companies can gather, connect, and contextualize the data and information they need for optimal manufacturing and quality assurance throughout the product’s lifecycle by integrating production record processes with ERP, MES, QMS (Quality Management System), and other core information systems.
Integrated into Qualityze EQMS (Enterprise Quality Management System) Suite, Qualityze EBR Management delivers industry-leading capabilities and functionality. The platform is built on Salesforce.com, providing flexibility, security, and performance. Furthermore, the system improves operational efficiency and allows your team to manage production issues with greater control and confidence.
Experience an easy and secure way to manage batch production data and processes with Qualityze EBR Management software.
Experience Qualityze Difference to Optimize Quality
Qualityze EQMS Suite enables you to maintain high quality standards while experiencing difference with:
Configurable Cloud-Based Platform
The Qualityze Electronic Batch Record Management solution is a next-generation solution that helps enterprises achieve manufacturing excellence by automating batch processes and data management. This software offers a combination of a configurable and cloud-proven structure that allows organizations to capture and analyze all the production-related details for improved decision-making. Moreover, you can configure the EBR forms as per your business needs.
Adherence to Compliance Standards
Qualityze Electronic Batch Record Management helps you align process workflows and configure EBR forms for various business and regulatory requirements to stay compliant. You can create either using the predefined form templates or configure them to your business needs. You can align batch data collection forms and templates with digital signature validation, following the guidelines of FDA 21CFR Part11 CGMP to manage electronic documentation and digital signature validation. You can also comply with GAMP5.
The Qualityze Electronic Batch Record Management Software provides organizations with an intuitive interface for capturing, managing, and tracking batch records in a standardized and streamlined manner without requiring technical expertise. Our cloud-based solution allows you greater flexibility to manage batch records, equipment records, reconciliation data, and validation records from anywhere. Experience the Qualityze difference for simplified batch record management processes.
Gain Real-Time Production Visibility to Ensure Quality from Day One
The Qualityze EBR software streamlines the management and reporting of production batch records. The user-friendly and responsive interface makes it easy to set up master batch record documents. Furthermore, you can use digital signatures to validate the data at every data entry stage. Integrating it with enterprise quality systems helps you perform material inspections, training, prerequisite verification, production audits, and reconciliations. This way, you will comply with regulatory requirements, analyze & improve the manufacturing process, meet audit requirements, and drive efficiency, on-time delivery, and profitability.
Combining best practices and cloud technology, Qualityze EBR Management makes batch records easier to manage. A central repository for all EBR records allows your team to keep track of production trends and make better decisions to reduce deviations. Therefore, your bottom line will improve.
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