Enterprise Quality Management System Software for Pharma and Biotech
Maintaining the highest quality levels and strict regulatory compliance affects the bottom line. It can be a matter of life and death for the life sciences industry, including biotechnology and pharmaceutical manufacturers.
To protect both companies and consumers in meeting increasingly strict FDA and other regulatory body demands. It’s essential to understand and meet the challenges of global deviations, corrective and preventive action (CAPA), adverse event management, change control, audit management, supplier quality, and overall product quality management.
In addition to the FDA’s stringent 21 CFR Part 11, 210/211, 820, ICH requirements, and ISO standards, companies face severe regulatory scrutiny from the Department of HHS and its HIPAA patient privacy regulations. It is incumbent upon pharma and biotech manufacturers to use the software, hardware, and system processes that ensure only those required to see a given piece of data can access it.
AssurX software is designed with enterprise quality management, cGXP, and life science-specific regulatory requirements in mind. Successful pharmaceutical and biotech companies are using the AssurX QMS software platform to monitor, manage centrally, and improve their quality and regulatory compliance processes—and the bottom line—across all operations.
“We are a fast-growing company and our systems need to be ahead of our growth,”
Enterprise Quality Management Built for FDA Compliance
AssurX quality management software system is designed to support requirements and standards for FDA regulated industries. The solutions seamlessly integrate, creating an ironclad closed-loop system to identify, track, resolve, document, and report all quality and compliance issues across every part of operations—even into the supply chain.
Using AssurX’s closed-loop quality management software, you not only know immediately when an issue arises (from any source: customer, supplier, internal), all relevant areas of your organization share the information needed to contain, evaluate and quickly resolve the problem. By utilizing powerful, real-time analytical tools, the software helps companies identify, assess, and remediate risk exposure, perform the detailed trend analysis needed to prevent quality and compliance problems, and continually improve operations. AssurX boasts mature compliance management capabilities with extensive audit trails, security controls, and electronic signature and records functionality that meets or exceeds rigorous standards of regulatory requirements.
The AssurX software is validated and comes with IQ/OQ validation templates. Each preconfigured solution comes with a PQ based on industry best practices and the latest regulatory guidelines.
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AssurX QMS For Pharma | Biotech Features
AssurX delivers central control and improved compliance and business performance.
Automatically track, trend, resolve, and document all product issues—initiated from any source, across all functional areas—before they become costly or dangerous problems. Reduce and prevent quality incidents. Control costs and make a better product the first time around.
Designed to meet changing cGXP, HHS, and other FDA regulations, the software guides users step-by-step through the process to meet requirements. Preconfigured forms contain all pertinent information blocks required for compliance and smooth operations, dramatically reducing the risk of non-compliance.
Enterprise Intelligence With Dashboards, KPIs & Metrics: Get real-time trending and global oversight with graphical dashboards and analytics that deliver instant business intelligence, accessed anywhere with an Internet connection.
21 CFR Part 11 Compliant
Electronic Records; Electronic signatures, 21 CFR Part 11: AssurX’s solution is designed to meet or exceed strict regulations audit trail and e-data integrity requirements.
Enables HIPAA Compliance
Make certain e-data is open only to those who are allowed to see it. AssurX makes it easy to “lockout” those who aren’t authorized to view any e-data field that requires shielding.
Risk-based Quality Management
Built-in risk assessment features for critical QMS processes such as CAPA and a robust Risk Management solution helps you prioritize activities and meet ISO standards for “risk-based thinking” in quality management systems.
Integrate to ERP, LIMS, HR, SCM, internally developed applications, databases, etc., using a robust, flexible open interface.
One QMS Platform Delivers Every Pharma | Biotech Solution