Pharma | Biotech

A QMS system designed to address the complex

requirements of regulations and standards

REGISTER NOW! | October 9 – 11, 2023 | Nashville, TN

Pharmaceutical Quality Management System Accelerates Time to Market

Life expectancy and quality of life throughout the world is increasing, thanks in large part to innovative drugs. Companies in the pharmaceutical industry and the biotechnology industry must develop new medicines in a timely manner to continue their life-enhancing missions. The stopwatch is ticking every day your product isn’t on the market.

Compliance with current good manufacturing practice (cGMP) regulations is a part of standard pharmaceutical quality operations. However, the use of legacy systems and paper-based processes make it difficult to control processes and systematic oversight.

AssurX’s pharmaceutical quality management system automates of all processes required to ensure that final products are manufactured according to customer and regulatory requirements. A platform of interconnected workflows resolve and prevent quality deviations.


An international multi-plant pharma & chemical company bogged down by labor-intensive manual processes implements the AssurX platform to streamline—saving more than 10,500 personnel hours per year.

AssurX Pharmaceutical Quality Management System Facilitates Compliance

The pharmaceutical and biotechnology industry face some of the strictest regulations today. Although the requirements vary, all encourage the utilization of automated, risk-based quality management techniques in all aspects of production and quality assurance.

AssurX is designed to address the complex requirements of regulations and standards, including:

21 CFR Part 210

cGMP for Processing, Packing and Holding of Drugs

21 CFR Part 211

cGMP for Finished Pharmaceuticals

21 CFR Part 11

Quality Management Systems

21 CFR Part 820

Pharmaceutical Quality System

Q10 Pharmaceutical Quality

Pharmaceutical Quality System


Quality Risk Management

CGMP Regulations

for Pharmaceutical Manufacturers

ISO 9001

Quality Management Systems

AssurX Pharmaceutical EQMS: Features and Benefits

Managing the drug development is a lengthy, costly, and complex process. Utilizing the right pharmaceutical EQMS gives your organization the tools needed to: manage all deviations, measure customer satisfaction, create standardized documents, facilitate training, assure consistency between QMS requirements and guidelines, and incorporate additional quality management processes into your system.

AssurX features and benefits for drug manufacturers include:

A fully automated platform increases in efficiency.

In the race to be best in market, a labor-intensive manual system only creates delays and a reactive stance for managing quality issues. Fully automating your pharmaceutical quality management system eliminates errors, moves tasks along a predictable patch, provides proactive insights, and increases efficiency and productivity. A fully-automated system speeds up turnaround time and reduces errors from manual input.

A closed-loop, centralized platform provides a single source of truth.

AssurX seamlessly connects document control, training management, deviations and CAPA, audit, and other quality processes in an integrated platform. Users and stakeholders have one system for all quality documents and task management. Likewise, auditors and regulators will be able to view all quality information in one place.

Complete transparency increases accountability.

Automated rules create transparency across the quality management system with insight into all tasks and the person(s) assigned to each task. Dashboards and analytics make it easier to pinpoint bottlenecks and gaps in your processes. Such transparency increases accountability to help improve performance.

Robust analytics help mitigate quality issues.

Analytics and reporting tools facilitate monitoring of quality issues and give you a 3600 picture of your current state of compliance. Generating timely reports and metrics enables users to drill-down into trends in order to analyze issues and prioritize mitigation and preventive strategies.

FDA 21 CFR Part 11 compliant audit trail and e-signatures ensure data integrity.

The FDA requires data integrity to ensure product quality and patient safety. AssurX’s audit trail and electronic signature capabilities exceed the expectations of 21 CFR Part 11 requirements. The secure audit trail automatically captures any changes made to records, who made them, and when. The system also controls user rights and access to reinforce security to maintain data integrity.

“We integrated several solutions into our system including deviations, CAPA, complaints, disposal management, and laboratory incidents. People adapted very quickly and very easily to the software.”

Quality Management System Validation Services

Computer system validation (CSV) traditionally meant validating all QMS software features and documenting all details. AssurX offers CSA validation services based on the FDA’s risk-based approach, dramatically reducing validation time and cost.

AssurX: Quality & Compliance Systems for Every Enterprise

AssurX is designed for every type of enterprise with strict quality requirements, including companies in the pharmaceutical and biotechnology industry. AssurX specializes in quality management systems for the life sciences, with more than two decades of experience built into the AssurX QMS software solution. Companies throughout the world rely on our solutions and services to manage and improve drug and combination product manufacturing quality.

One Platform. Every Solution.

Seamlessly integrate all quality management and regulatory compliance management processes with one software system. AssurX provides all core quality and compliance processes within the software system, eliminating the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one.

First, implement the solutions you need now, then seamlessly connect more as you are ready. No other system is easier to deploy, configure, and modify.

Audit Management

CAPA Management

Calibration Management

Change Management

Complaint Management

Customer Quality Management

Deviation Management

Document Management

EHS Incident Management

Nonconformance Management

Quality Management Review

Risk Management

Supplier Quality Management

Training Management

Validation Management Solution