Controlled execution
Standardize production with guided workflows, enforced checks, and real-time controls.
Next-Gen Quality Management. Built for Compliance. Powered by AI.
Right-first-time manufacturing starts here. Built for regulated environments, Qualityze helps teams prevent execution errors, reduce deviations, shorten batch release cycles, and improve productivity. Leaders get the real-time visibility across operations, quality, and compliance required to make data-driven decisions and achieve excellence.
End-to-End Batch Record Management
Qualityze enables controlled digital batch execution through guided workflows, electronic signatures, audit trails, and built-in process controls that support alignment with global GxP practices.
Closed Loop · AI Insights Feed the Next EBR Workflow · Qualityze Intelligence
Qualityze makes it easy to collect and manage all the important information about batch records, like production data, equipment used, operator details, material lists, key dates, and analysis. All of this is stored in one secure centralized platform. This makes it simple to find what you need, reduces paperwork, makes work more efficient, and ensures no important details are missed.
Operational Benefits
See how Qualityze helps quality teams to improve the KPIs that matter most, including batch release speed, right-first-time yield, deviation reduction, QA efficiency, productivity, compliance readiness, and manufacturing throughput, to consistently meet expectations for Delivered Quality.
Right-First-Time Manufacturing with End-to-End Visibility
Standardize production with guided workflows, enforced checks, and real-time controls.
Track batch progress, exceptions, and production readiness across sites.
Reduce deviations, accelerate batch release, and scale production with consistency.
Key Challenges
Qualityze transforms batch record management from a compliance obligation into a strategic driver of operational efficiency, manufacturing agility, and business growth.
Manual review of batch records often delays QA approval and product release,
Qualityze: Automated batch record workflows and review-by-exception processes with approvals.
Teams spend excessive time reviewing and investigating batch records and getting approvals.
Qualityze: Standardized workflows, automated checks, and centralized record management.
Manual documentation processes increase the likelihood of missing records, unauthorized changes, and audit observations.
Qualityze: Enforces role-based access, audit trails, electronic signatures, and compliant record controls.
Batch-related information is often scattered across ERP, MES, LIMS, and quality systems, making it difficult to gain a complete view of production performance.
Qualityze: Helps create a single source of truth for batch execution and review.
Quality events discovered during batch review frequently trigger manual investigations that delay product disposition.
Qualityze: Links deviations, nonconformances, and investigations to batch records for traceability.
Determining material lineage, affected lots, or manufacturing history can require significant manual effort during audits, complaints, or recalls.
Qualityze: Maintains complete lot-to-batch traceability by integrating manufacturing, supplier, and quality data.
Cost of Quality
Replace paper-based processes with a connected EBR platform that reduces errors, accelerates batch release, and strengthens compliance.
Typical cost-of-quality split, Manual Batch Records Managements vs. Closed-Loop EBR Management
Cost of Reactive Safety— with Manual Batch Records Management
~70% of COQ
Cost of Proactive Safety — with Qualityze Electronic Batch Record Management
~30% of COQ
Establish standardized batch execution process with validation and verification checks.
Build stronger process controls for batch review and release without any delays or errors.
Enable review by exception and real time visibility for your EBR records.
Establish repeatable processes for continuous compliance and quality excellence.
System Capabilities
Purpose-built for regulated, quality-driven organizations, Qualityze helps quality teams connect batch execution, quality checks, exception management, review, and release in one centralized system.
Track all your Electronic Batch Records in a validated and centralized system with a detailed audit trail for regulatory requirements.
Track the data of any record (including the processes involved, verification data, reconciliation data, and much more) using the unique reference number the system assigns to each record.
Track equipment health for due calibrations and maintenance schedules to avoid unnecessary delays, downtime, or incidents.
Track materials used in production, including quantities, quality, and expiration dates.
Manage line/room clearance activities with checklists and documentation storage.
Track all production steps from order creation to verification, including quality control.
Ensure data validation for faster verification and reconciliation of batch quantities and materials used, keeping batch records audit ready.
The system comes with pre-defined EBR form templates to collect batch information in a consistent manner.
Customer stories
Hear how quality and compliance leaders bring audit planning, execution, and follow-up into one connected process.
“Qualityze Calibration Management system has vastly improved and streamlined our calibration management process. Prior to Qualityze, we relied on a very manual process to track tools going in and out for calibration and maintaining what was due. Now we are able to automate this tracking and pull real-time status reports. Throughout the implementation process Qualityze has been a great partner. Qualityze helped us customize the platform to best fit our needs and they are always available for questions and readily solved any issues we encountered. They have made our transition from manual to automated tracking very seamless.”
Allison Hacker
Qualityze EQMS Implementation Experience!!!!, Allison Hacker
“When I transitioned from a large organization that had successfully utilized Qualityze for years to LifeMD Pharmacy Services, LLC, where I was tasked with building a new pharmacy from the ground up, I knew I wanted to implement Qualityze again. The platform's capabilities are robust, and the training is thorough, to make setup process easy and the results are absolutely worth it. Currently, we leverage the Document Control, Permit Management, and NC/CAPA modules, all of which have been instrumental in streamlining our operations. I highly recommend Qualityze's solutions to anyone in the pharmacy industry seeking efficiency, compliance, and reliability.”
Adam Womack
Qualityze EQMS an Awesome Experience!!!, Adam Womack
“We were tasked with moving into a new EQMS with a very short timeline for multiple modules. Then we were tasked with moving our information into a different instance of Qualityze about a year later. In both cases, the Qualityze team was fantastic at listening to our needs and developing solutions without compromising the project timelines. They were also very helpful with setting up our AS2 account for eMDR so that we were ready to submit at go-live. It has been a pleasure working with them through two set ups. As we continue to use the system and come up ways to refine our processes, the Qualityze team is always available to support us and keep us running at top speed. The software itself is very intuitive and was very easy for my team to learn. A few members of the team were apprehensive to learn a new system, but they adjusted to it quickly and were up to normal production levels within a couple of days. A life-saver has been the ability for each team member to create our own reports with data that is the most useful to us. Not only are the reports fairly easy to create, but the ability to save a favorites list and bring up reports with a single click of the button allows meetings run faster and smoother without prep time. Additionally, the reports easily keep my team members on track with their tasks throughout the day so we don’t miss any deadlines to government agencies or competent authorities. I would definitely recommend Qualityze to anyone searching for a new eQMS!”
Teresa George
Qualityze eQMS has Awesome Service and a Great End-User Experience!, Teresa George
“We have been thoroughly impressed with Qualityze’s Change Management system. Since implementing Qualityze over a year ago, our document review and approval processes have become significantly more streamlined. Qualityze ensures that all employees have access to only the most current, approved versions of documents—whether SOPs, work instructions, or forms. This has been especially beneficial during both internal and external audits, providing confidence in our document control and compliance. Additionally, the peace of mind that comes from knowing outdated documents are inaccessible for daily operations has greatly reduced the risk of errors from using incorrect information. Qualityze’s customer support is top-notch, and our project manager is always quick to provide excellent solutions to any question or issue that might arise. Utilizing Qualityze has been a game-changer for our organization.”
Heather Baughman
Quality Document Control with Qualityze, Heather Baughman
“I have been working with our Qualityze Customer Success Manager on the CAPA module implementation since early last year and highly appreciate the support and timely responses. The flexibility and configurability of the Qualityze system allowed us to configure our CAPA module quite a bit to achieve our look and feel and site-specific business workflows. The Customer Success Dept has closely worked in close liaison with the Qualityze development to ensure a smooth configuration and implementation. I 100% recommend Qualityze software and Customer Success team for your EQMS Implementation!”
Sihua (Sue) Xu
Qualityze EQMS Implementation Experience, Sihua (Sue) Xu
“We are a Biomed Mems consulting company working with customers who are developing technologies for medical implantable devices. We are a current user of Qualityze EQMS and have recommended and helped two of our customers implement their own Qualityze EQMS. With its user-friendly interface and customizable features the system has been a breeze to use. What truly impresses us is their exceptional service post implementation as they are always available to help with any issues or questions that arise. The onboarding process was very smooth and the training provided had all users functioning very quickly. Overall, Qualityze EQMS has transformed our quality processes and is an invaluable partner in our success and that of our customers.”
Del White
Qualityze EQMS - Excellent Partnership, Managing Director – Grynova Consulting Group
“Several groups within our organization needed to move out of another vendors document and training management program. Qualityze was chosen as a competitive alternative. The Qualityze team was patient with our transition delays and the timeline adjustments needed for our organization. Working closely with our internal team, the Qualityze team made the adjustments to the out of box system modules to meet our specific requirements. Implementation timelines were met with satisfied internal customers and in time for our manufacturing team’s external ISO 9001:2015 certification plans. As we continue to expand our EQMS programs with Qualityze, we look forward to the next module implementation project and rapid deployment of the production systems to improve our Quality program.”
Jake Criss
GreenLight Biosciences (GLB) - Qualityze EQMS Document and Training Management Implementation, Jake Criss
“CavinKare was in search of an EQMS company to create a centralized repository for our technical documents, allowing controlled access to our global factories. During our search, we came across the Qualityze team, who provided us with a comprehensive and satisfactory demonstration that aligned perfectly with our expectations and requirements. Our interactions with the Qualityze Professional Services team were excellent; they clearly understood our needs and configured the system to meet our expectations. Today, all our facilities utilize multiple Qualityze products, featuring a centralized data repository for Quality and Compliance. The Qualityze system is remarkably user-friendly and seamlessly accommodates users at all levels, from our Business Head to operators. We are extremely pleased to have easy access to all our controlled documents on a daily basis, and the system was quickly embraced by all our users. Qualityze EQMS has become one of our critical systems for addressing audits from external agencies and government entities, providing the necessary evidence to meet all requirements. Our entire team has been using the system for a couple of years now, and we have become reliant on it for accessing the latest technical documents available at any site. We extend our heartfelt thanks to the entire Qualityze team for their support in constructing such a unique system, serving as a single point of access to meet all our requirements”
Kalaichelvan Anbazagan
Qualityze EQMS Implementation, Kalaichelvan Anbazagan
“My team and I were looking for an audit management system to accommodate a unique audit workflow. Working very closely with the Qualityze technical team, I can honestly say that they were always patient and provided me with clear guidance on how the system could be configured to meet our requirements. I was very pleased with how quickly the system was ready for testing and production. The Qualityze team was flexible and agreeable to multiple training sessions for our staff and customers who would be using the system. More importantly, they were always there when I or one of our audit customers had questions. The Qualityze team’s Product Manager’s knowledge and responsiveness was much appreciated during the entire process. Without hesitation I recommend Qualityze to other businesses looking for an audit management system.”
Marilyn Miles
Qualityze EQMS Implementation Experience, SVP, Advisory Consulting COMPLY
Achieve right-first-time manufacturing with a cloud-based EBR solution that connects execution, quality, review, and release on one platform.
Enterprise security, scalability, and stability with SSO, MFA, and role-based access that quality leaders and teams' trust.
EBR, Audit, and Nonconformance management share one centralized platform, so you can manage quality and safety events promptly.
Validated, 21 CFR Part 11-ready electronic records with electronic signatures and a complete, tamper-evident audit trail for every action.
Configure workflows, forms and reports to your business and industry specific compliance needs without writing a single line of code.
Establish best practices and controls to achieve excellence in manufacturing operations.
EBR Management is one pillar of the unified Qualityze suite of enterprise solutions designed for manufacturing excellence.
Get a complete overview of capabilities, deployment, supported standards, and integrations in one downloadable reference.
The data sheet gives you a quick snapshot of the value you get from Qualityze AI-enabled, cloud-based Batch Record Management System.
Configure EBR workflows based on applicable regulatory requirements.
Build EBR workflows with enforced instructions, checks, and electronic signature validation.
Prevent errors at the source to reduce deviations and rework for consistent product quality.
Use review-by-exception capabilities to accelerate batch review and release cycles.
Align EBR workflows with applicable regulatory frameworks and industry compliance requirements.
Connect Batch Record Management to enterprise quality and safety management systems.
One configurable quality framework that adapts to the compliance demands of every sector — from life sciences to heavy manufacturing.
Qualityze 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.
Discover how our next-generation quality platform can help your team reduce quality costs, resolve issues faster, standardize processes, and drive continuous improvement across your operations.
