Enterprise Quality Management System Software for Pharma and Biotech

Maintaining the highest quality levels and strict FDA and other 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.

It’s essential to understand and meet the challenges of controlling and documenting 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 designs software 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, and improve their quality and regulatory compliance processes—and the bottom line—across all operations.

“AssurX…allowed easy management of all CAPAs on a local level as well as knowledge exchange between management throughout the global organization.”

– Manager, Global Quality
Info Systems

bausch and lomb life sciences company selects assurx quality and compliance management

Efficient, cost-effective enterprise quality management system that meets and exceeds pharma and biotech regulatory requirements.

AssurX QMS - Pharma and Biotech Solutions


One seamlessly connected solution to improve quality, ensure compliance, manage risk, and streamline workflow.


Every solution is built for FDA, ISO, ICH, and cGXP. Solutions are built on a robust, consistent UI/UX, that supports ease of use, critical data integrity, and data quality.


Automatically orchestrate and track activities, share data, and communicate information to the appropriate internal and external parties.


Dashboards provide live, clear views of coordinated activities and information across all areas of the business to direct user actions.


Manage operations while detecting, correcting, and preventing potential issues.


Simple to deploy, configure, use and modify.


Powerful real-time trending and analytical tools.


Available as either traditional On Premise (licensed software) or in the AssurX Cloud.


Product Overview

Watch this Video Overview of the AssurX Quality Management System Platform.

Customer Testimonial

Listen to What Other Life Sciences Manufacturing Professionals Have to Say About AssurX.

Case Study

Learn How a Global Pharmaceutical Manufacturer Was Able to Eliminate Over 10,500 Personnel Hours Per Year Using AssurX.




“We are a fast-growing company and our systems need to be ahead of our growth,”

TEDOR Pharma

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.

Robust Quality Management for the Pharmaceutical Industry

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.

Built for Connected Compliance

Not only fully compliant with 21 CFR Part 11 and Part 820, but it is also flexible enough to keep you in compliance with changing cGXP requirements. AssurX’s preconfigured closed-loop solutions deliver fully FDA-compliant processes to manage audits, deviations, risk management, supplier quality, document control, corrective and preventive action (CAPA), change control, and more. In contrast, a state of control and proof of compliance is maintained continuously in one central, securely accessible system.

The AssurX software is validated and comes with IQ/OQ validation templates. Each pre-configured solution comes with a PQ based on industry best practices and the latest regulatory guidelines.


AssurX QMS For Pharma | Biotech Features

AssurX delivers central control and improved compliance and business performance.

CAPA Integration

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.

Business Intelligence

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.

Simple Integration

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

Document Management

Training Management

Audit Management

21 CFR Part 11 Compliant


Risk Management