Closed-Loop CAPA Management Software

Using AssurX, you can automate all the steps required to evaluate and investigate deviations. You can also implement the appropriate actions and controls to prevent further quality incidents. Corrective and preventive action software can help you streamline your quality management process. AssurX CAPA management software also helps you track improvements and perform thorough root-cause analyses. This is one of the key features of our corrective action tracking software. In addition, the tightly integrated corrective and preventive action (CAPA) solution integrates with additional processes, data, and documents to drive quality improvements even further. AssurX CAPA management software enables your enterprise quality management system to be self-correcting. It guides your organization from incident capture to closure while creating continual improvements in your quality chain. In addition, effectiveness checks and compliance verification with corrective action management software gives you confidence in your ISO and GxP alignment. If you use CAPA for FDA, then CAPA software will make it easier to manage FDA CAPA system standards and regulations. Regardless of your industry, our CAPA management software can help you maintain certification standards.

AssurX corrective action software system is designed to address regulatory requirements in regulations such as:

21 CFR Part 820

• Quality System Regulation CGMP Regulations
• Pharma/Biological Products 21 CFR Part 11
• Electronic Records; Electronic Signatures EU MDR
• EU Medical Device Regulation ISO 9001
• Quality Management Systems ISO 13485 Medical Devices
• Quality Management Systems CGMP Regulations
• for Combination Products EU IVDR
• EU In-Vitro Diagnostics Regulation

How AssurX Modernizes Your CAPA Management Process

AssurX CAPA management software eliminates paper-based and unconnected electronic systems and the related costs associated with day-to-day manual operations. By automating the CAPA process and integrating with additional quality processes with the following features and benefits:

Compliance Excellence

An end-to-end approach to CAPA actions provides significant compliance advantages. If process gaps are found at any time during the CAPA process, a change record can be launched. If documentation needs to be updated, AssurX Document Management gets the revision completed and approved. It can also can trigger a training task.

On-Demand Data

Provides efficient data and document retrieval and management. Reporting includes the ability to display specific records, including any attached images. Always know exactly where you are in the CAPA process. Trending and data analytics provide intelligence to pinpoint related issues and take proactive measures to address them.

Integration

CAPA software can be launched anywhere in your electronic quality chain. As a result, audits, non-conformances, deviations, supplier quality issues, and customer complaints all connect in a closed loop. With AssurX, you’ll be able to clearly determine that you have a quality issue. Our CAPA management software can then seamlessly trigger a CAPA.

Data Maximization

AssurX integrates with other business applications to provide greater insight and collaboration (for example, in CAPA investigations). Connect with MES, LIMS, ERP, CRM, and others to integrate your applications under a single CAPA software. This allows you to engage with other business areas seamlessly.

Centralization

Automate all CAPA-related tasks (routing, follow-up, escalation), under a centralized CAPA system to eliminate process vacuums.

Efficiency

AssurX CAPA management software speeds your time to CAPA completion. Tracking, automated reminders, escalations, and configurable dashboards keep assigned users on-path to task closure.

Auditability

AssurX CAPA software captures all related CAPA details including signatures and documentation. It creates a controlled way to organize report findings and attach related evidence records in one place.

Control Risk

A risk-based approach facilitates identification, analysis, and prioritization of risks in our CAPA software. As a result, the appropriate actions can be taken to proactively control and minimize the chances of future negative outcomes.