CAPA Management Software – MasterControl

What is CAPA Management Software?

No matter how diligently one strives to prevent them, quality events are bound to occur. Within the framework of a quality management system, Corrective and Preventive Action (CAPA) identifies and deals with the underlying triggers of significant quality concerns, thereby curtailing the ensuing business repercussions, both in the immediate and long-term contexts.

• Quality improvement and compliance maintenance rely on a strong CAPA management software.
• CAPA serves a dual purpose: identifying reasons for quality issues like nonconformances, and preventing their recurrence.
• CAPA processes cover multiple quality systems and their generated data.
• An integrated digital CAPA solution links quality channels and downstream processes across the product life cycle.
• This integration leads to a streamlined and comprehensive CAPA management software.
• Benefits include enhanced product quality, safety, and overall compliance.

Why CAPA Management Software?

Does your system make use of CAPA software, which serves as the driving force behind quality?

• Stay Compliant With 21 CFR Part 11

  • FDA 21 CFR Part 11 introduced in 1997 for electronic system use in industries.
  • Growing industry shift towards digital systems for compliance tasks.
  • Regulation remains highly significant due to widespread digitization and automation.
  • MasterControl offers a unified cloud-based platform for streamlining GxP processes.
  • MasterControl automates quality and business processes for enhanced efficiency.

• Implement Closed-Loop CAPA

  • CAPA process involves multiple actions, data inputs, and documents.
  • Closed-loop CAPA methodology aids companies in making quality decisions.
  • Results in consistent outcomes while retaining a comprehensive, compliant, and traceable audit trail.

• Advance Beyond CAPA Toward Innovation

  • CAPA systems evolving and maturing in companies
  • Goal: Progress from safe CAPA to proactive quality event management
  • Challenge: Balancing traditional CAPA methods and innovative approaches
  • Achieving balance is a mix of art and science

• Discover 7 Steps to Simplify CAPA

  • A robust CAPA process comprises seven essential actions to be performed and monitored.
  • Documentation of these actions is frequently insufficient.
  • This white paper clarifies CAPA by dissecting its components.
  • It offers a straightforward, sequential approach for capturing, handling, tracking, and analyzing vital CAPA actions.

• Perform CAPA on Your CAPA System

  • Essential CAPA process ensures product quality and safety.
  • Inadequate systems hinder proper execution per regulations.
  • Discover methods to evaluate and enhance your CAPA system.
  • Stay compliant by implementing necessary improvements.

• Automated Processes

  • MasterControl CAPA software digitizes CAPA processes
  • Automates routing, notification, escalation, and approvals
  • Prevents bottlenecks in CAPA procedures
  • Speeds up issue resolution

• Integrated Quality

  • Integration of CAPA with core quality management systems
  • Initiates change control, training verification, and task tracking automatically
  • Ensures compliance with FDA 21 CFR Part 11 requirements

• Form-to-Form Launching

  • Fully digitized and automated CAPA system
  • Enables direct form launch from customer complaints
  • Allows launching from deviations, nonconformances, audits, and out of specifications
  • Extends to various sources for initiating forms

• Data Tracking and Trending

  • Gain visibility throughout the CAPA process
  • Analyze data for trend identification
  • Enhance overall quality management

• Fully Connected, Reliably Compliant

  • CAPA (Corrective Action/Preventive Action) is crucial for quality systems.
  • It must be managed effectively to meet FDA and ISO demands.
  • MasterControl CAPA software provides a user-friendly, closed-loop solution.
  • It automates CAPA and links it with other quality event processes.
  • This ensures a comprehensive, connected, and compliant approach.

CAPA Management Software Dealer/Reseller

Factonity Systems Pvt Ltd is a full service dealer & reseller of CAPA Management Software. Apart from software licensing, we also provide authentic software training, local technical support and statistical consulting.

Please contact us for:

• Latest CAPA Management Software pricing information / quotation
• Demo of CAPA Management Software and free initial consultation
• Lean Six Sigma + CAPA Management Software bundled training with licensed of demo software
• Post sales local technical support

Who uses CAPA Management Software?

The MasterControl software combines CAPA processes with the complete product life cycle, creating a comprehensive method for managing quality and CAPA in a unified manner.

Which industries use CAPA Management Software?

Leading corporations utilize this software. Below are a few industries that leverage the capabilities of this software: