Corrective and Preventive Action (CAPA) Software

TEAR DOWN QUALITY PROCESS SILOS AND SET THE FOUNDATION FOR CONTINUOUS IMPROVEMENT WITH A CAPA MANAGEMENT SYSTEM.

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:

Quality System Regulation

Pharma/Biological Products

Electronic Records; Electronic Signatures

EU Medical Device Regulation

Quality Management Systems

Quality Management Systems

for Combination Products

EU In-Vitro Diagnostics Regulation

CASE STUDY
How Highline Warren, a $1B manufacturing organization, went from a paper & pencil CAPA system software to digital with AssurX.

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CAPA Software for Continuous Quality Improvement

CAPA management software is a modern essential for regulated companies. More importantly, it’s a basic element of continuous quality improvement. AssurX connects the CAPA process with document control, change management, training, deviation, non-conformance, audit, and other quality processes.

Desktop displaying CAPA Management Dashboards and Analytics

AssurX CAPA software provides a centralized platform and robust tools that can enable your organization to:

  • Assure management that all quality issues are resolved

  • Reduce the severity and rate of customer complaints

  • Reduce product recalls

  • Promote continuous improvement

  • Reduce scrap and rework

  • Reduce returns and minimize warranty expenses

“We chose AssurX for its ease of use, the ability to configure the system to our workflow, solid architecture for quick deployment worldwide, ease of integration with ERP systems such as SAP, as well as for its advanced query functionality.”

AssurX CAPA Software Video Demo

Watch a 9 Minute Video of the AssurX CAPA Management Solution Now

See how the AssurX CAPA software solution demo provides robust functionality. Our effective CAPA management software replaces paper processes and information silos with a single point of truth.

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.

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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. This eliminates the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one with our quality management software.

AssurX is an exceptional platform that facilitates transitioning from a labor-intensive, paper-based process to a streamlined electronic system. By adopting AssurX, you can embrace the enhanced organization that comes with digitizing documents and files.

With AssurX, everything is easily searchable, allowing for quick retrieval and efficient information management. This level of organization drastically improves accessibility to records, reducing the time wasted.

First, implement the solutions you need now, then seamlessly connect more as you are ready. No other quality management system is easier to deploy, configure, and modify. Integrations with other software solutions make AssurX invaluable. Your data won’t be stuck in several silos. Instead, you’ll have one unified system for optimal efficiency.

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