Qualityze Inc attends ISO 9001 and Audits World Conference, gains valuable insights on quality management and auditing!

Tampa, FL USA, 23rd March 2023: Qualityze is pleased to announce our recent participation in the ISO 9001 and Audits World Conference. The event took place on March 13-14, 2023 and brought together professionals around the globe to discuss quality management and auditing. The ISO 9001 and Audits World Conference is a premier event in […]

CAPA Management: A Holistic Approach to Resolve Quality Issues

Highly regulated industries require a standardized, repeatable CAPA (Corrective and Preventive Actions) management process to eliminate systemic quality issues, such as deviations, defects, and nonconformances. This is achieved by identifying and addressing the root cause(s) of issues (not the symptoms) through efficient investigation to prevent recurrence. Industry leaders are upgrading their traditional CAPA processes with the next-generation CAPA Management software solutions to overcome challenges like visibility, inefficiency, and disparate systems.

Qualityze CAPA Management enables organizations to develop a risk-based, compliance-driven process for addressing systemic issues to prevent recurrence. It guides the user through a comprehensive approach for mitigating quality issues while meeting compliance and fostering a culture of continuous improvement. 

With Qualityze CAPA Management Software, you can standardize your CAPA process to:

Documenting the Root Cause(s)
Planning the Resolution Activity
Investigate, Identify Root cause and Risk Assessment

Define and Implement Action Plan
Verification and Effectiveness Review

CAPA Management Overview

Managing systemic issues in a timely, effective, and compliant manner requires organizations to establish a standardized CAPA management process. Qualityze CAPA Management helps you build closed-loop CAPA processes to eliminate inconsistencies from the system and drive continuous improvements. With our integrated solution, you can drastically enhance your planning and decision making with more control on data. It gives you quick insights of CAPA trends, performance, and effectiveness of the resolution. You can utilize different investigation tools too. With Qualityze CAPA Management, you can effectively and efficiently perform:

CAPA Initiation
Investigation
Root cause analysis
Risk assessment
Planning & Implement Action Plans

Effectiveness Review
Resolution Activities
Verification
Digital Signature Validation

Corrective Action Preventive Action System

Documenting the Root Cause(s)

Quality issues potentially arise from several subsystems that are put in place to support the Quality Management Software within the organization. Every issue including improper design; inadequate product specification; failure of purchased materials; inadequate manufacturing instructions, processes, tools or equipment; inadequate training or lack of training; inadequate resources, needs to be reported and tracked in a systematic manner. And Qualityze CAPA management system offers you the same functionality in a series of steps starting from the Initiation Step where you can capture all the requisite information like:

Title
Problem Statement
CAPA Source & Source Number
Numbers

Reported Date
Reported By
Criticality
CAPA Owner & others

Like Qualityze Nonconformance Management Software, CAPA software is also configurable. You can easily create new fields as per your business information needs. On saving each record, you will get a unique number to keep the track of the CAPA process for the issues reported.

Planning the Resolution Activity

Once the documentation step is done and you have got your unique reference number to track the process. The next step for you, as a CAPA owner, is to proceed with the planning of the resolution activity. The Qualityze CAPA Management Software helps you with the planning through its resolution step, wherein you get an initial risk assessment for planning the course and level of investigation. We completely understand that not every CAPA issues needs to undergo same level of investigation. The extent of the investigation depends on the several factors such as criticality, the risk to a patient, risk to the company, extent of the defect etc. The Qualityze CAPA Management System offers you two options either to go ahead with the CAPA workflow or to opt-out the CAPA depending upon the criticality of the issue. if you choose to proceed with the CAPA workflow, you can further select/deselect the task, define the task owner, and the task due date, which is necessary for each CAPA record.

Investigate, Identify Root cause and Risk Assessment

Investigating the root cause is the most significant part of a CAPA practice in quality management system. Through Qualityze, you can easily document the investigation result or outcome in the Investigation task. Investigation task is the step where you document the root cause(s) and perform the risk assessment accordingly. You can list multiple root causes for an issue along with the resolution required and the result. Qualityze Corrective Action Preventive Action Management Software also allow you to record the entire investigation and analysis report for future reference.

Define and Implement Action Plan

We understand that not every issue reported in CAPA requires action. However, based on the root cause of the problem and the investigation data analysis, it may be necessary to develop an action plan.

Qualityze CAPA software is designed with an Implementation task to help creating action plans that can eliminate or minimize the cause of the quality issue. You can further categorize the action plans as Correction, Corrective, Preventive or Risk Based. Easy-to-use, this interactive solution allows you to document multiple actions plans in order to address the root cause, which was identified during the investigation task. Additionally, you have an option to document the verification plan in this task through which you can monitor the effectiveness of the implemented action plan.

Verification and Effectiveness Review

Corrective Action Preventive Action Management Software

Verification or validating the effectiveness of the action plans implemented is yet another vital step. In this step, you need to collect and analyze the entire data – be it the issue, its root cause, action plan, or resolution to ensure the overall efficiency and effectiveness of the implementation process. The Effectiveness Review task of the Qualityze CAPA Software allows to document the verification plan and objective evidence to validate the success of the action plans implemented. Additionally, in the Closure Review, you as a CAPA owner can make the determination whether the CAPA was effective in eliminating or minimizing the cause of the quality issue based on the analysis of the objective evidence collected in the Effectiveness Review task.

Why CAPA Management Is Important

CAPA refers to a process for identifying the root cause of problems encountered in a quality process, product, or workflow to make informed decisions about action plans to be implemented for effective resolution. It encourages any organization to:

Verify and validate the quality issues identified
Track the root-cause of these quality issues

Take proper corrective and preventive action(s)n
Document the problems, potential risks, and relevant solutions.

How does Qualityze CAPA Management Help Businesses?

We help organizations dig deeper into their quality issues using Qualityze intuitive and configurable workflows, fields, dashboards, and reports. These tools guide users through CAPA steps in a manner that helps them identify the source of quality issues to prevent their recurrence versus constantly reacting to occurrences.

With Qualityze CAPA Management, you can

Record CAPA-Related Information to Assess Risks
Minimize the CAPA Cycle Time
Ensure CAPA Effectiveness
Integrate the Nonconformance and CAPA Processes

Integrate with Existing Business Systems
Drive Continuous Improvement
Controlled CAPA Records and Data

Record CAPA-Related Information to Assess Risks

corrective and preventive action software

Qualityze enables you to capture all CAPA-related information in a single place using its user-friendly forms. Form fields typically include the Title, Description, Problem Statement, CAPA Source, an Auto-generated Number, Reported Date, Reported By, Criticality, and CAPA Owner. Organizations can add more fields to forms based on their needs. Using standardized forms and workflows to capture information helps maintain accuracy in reporting, analysis, and root cause investigation.

Whether the CAPA is triggered by a Supplier issue, an Audit, a Customer Complaint, or an internal Nonconformance, Qualityze CAPA Management allows you to adjust the workflow based on the criticality assigned to the issue. This provides organizations with a risk-based approach to resolving quality problems.

Minimize the CAPA Cycle Time

With built-in alerts and notification capability, automated email approvals, and configurable workflows, Qualityze CAPA Management can mitigate quality problems more effectively and efficiently than paper-based systems. It facilitates real-time collaboration with involved parties regarding investigations, approvals, reviews, action plans, and their implementation schedules to manage issues quickly.

Users can schedule the CAPA approvals and effectiveness reviews to ensure that they are implemented on time, reducing the overall CAPA cycle time. Qualityze CAPA Management also enables you to communicate with both internal and external parties, including suppliers, customers, and employees, regarding the impact of CAPA on regular operations. The rapid searchability of CAPA records and relevant information is significantly improved so you can easily track documented records, irrespective of their age or location.

Ensure CAPA Effectiveness

Qualityze CAPA Management allows you to perform effectiveness reviews that ensure corrective actions or preventive actions implemented are meeting expected performance targets. You can specify the verification plans to check the effectiveness of CAPAs. The configurable workflow allows you to add multiple verification plans to perform an effectiveness check. Additionally, you can re-initiate the process for the CAPA that failed to address the quality problem for which it was intended. Finally, users can provide justification details as closure comments.

You can further map CAPAs to their root cause(s) as a proactive approach to similar quality problems that may arise in the future, putting you in better control to manage risks in a proactive manner.

Integrate the Nonconformance and CAPA Processes

It’s easy to access all the nonconformances records related to CAPAs using our Qualityze CAPA management. For example, you can initiate a CAPA directly for a Nonconformance that requires a detailed investigation and root cause analysis. In other words, we have created a closed-loop system through a set of smarter quality solutions to help you succeed in quality management.

Because of our centralized database, Qualityze CAPA Management can collect and store all the information relevant to nonconformance, deviation, or defect in one place. In turn, this accelerates the investigation and CAPA implementation, reducing the process cycle time.

Integrate with Existing Business Systems

Qualityze CAPA Management seamlessly integrates with other business systems and third-party applications used within the organization. Whether you are using CRM, ERP, LIMS, MES, PLM or other systems, Qualityze CAPA module gives you the ability to share data with this application, improving data integrity and reducing administrative time and opportunity for errors. Additionally, personalized dashboards with these “data mashups” give your team a quick snapshot of all the tasks, reviews, approvals, and training records.

Integrating CAPA with existing enterprise systems allows you to take a more holistic and regulatory-compliant approach to quality management, enhancing effective problem resolution.

Drive Continuous Improvement

With Qualityze CAPA Management, you can leverage standardized reports to provide real-time visibility across your systems to identify compliance risks, improvement opportunities, and to make better business decisions. The system’s in-built reporting and trend analysis tools provide critical information to help drive continuous improvement efforts, enabling you to achieve operational excellence.

In short, Qualityze helps your organization to become more proactive in managing risks and to create a culture of continuous improvement.

Controlled CAPA Records and Data

Qualityze CAPA management standardizes permissions and streamlines the CAPA processes, ensuring that all your quality data and records are safe. You can leverage our role-based security controls, password authentication, and audit trail to trace the events and actions performed on quality data. Our system also supports digital documentation and electronic signatures to maintain compliance with regulatory standards, such as FDA 21 CFR Part 11.

Qualityze CAPA Management – Giving Industries More Control Over CAPAs

Qualityze CAPA Management works across all industries — Manufacturing, Life Sciences, Pharmaceuticals, Medical Devices, Nutraceuticals, Biologics, Food and Beverages, Automotive, Aerospace, and Defense Logistics — to assess risks and eliminate problems while maintaining compliance with applicable regulatory standards.

Qualityze CAPA Management Solution comes with a(n):

Centralized CAPA Database
Audit Trail
Risk Matrix
Personalized Dashboard
Task Scheduler
E-Signature Validation
Chatter Feature

Qualityze EQMS – The Enterprise Quality & Compliance Management Platform to Identify, Assess, and Prevent Systemic Issues

A robust CAPA management system is critical to improving product quality while staying compliant with industry and regulatory requirements. Our solution serves both purposes and helps you to prevent the recurrence of quality issues. The cycle time of a CAPA process depends on the quality process, ease of access to relevant information and the data produced. With Qualityze integrated CAPA Management, you can connect all the critical quality processes and data to ensure faster, better, and smarter decisions and resolution of quality problems, reducing the overall cycle time and cost of compliance. The processes are streamlined and comprehensive to help maintain consistent product quality, safety, and global compliance.

The Qualityze EQMS Suite helps enterprises align their key processes with the business strategy and quality objectives while mitigating operational challenges. Built on the most powerful and secure cloud platform, Salesforce.com, Qualityze provides unparalleled cloud benefits to manage your product quality challenges. We empower you to optimize your quality processes by giving you more control and confidence in addressing root causes to minimize rework and risk, allowing you to spend more time on growing your business and developing your people.

Qualityze prepares you to succeed with a next-generation approach to root-cause analysis and risk assessment that fosters continuous process improvement, market-share growth, and higher customer satisfaction.

Experience Qualityze Difference to Optimize Quality

Qualityze EQMS Suite enables you to maintain high quality standards while experiencing difference with:

Configurable Cloud-Based Platform

Based on the cloud-based Salesforce platform, Qualityze CAPA management software solution can be easily configured, based on the industry requirements to avoid unnecessary workload. Our solution will not overburden you with maintenance and upgrade costs. The cloud platform provides you complete flexibility, security, and scalability to manage voluminous CAPA records on a centralized platform. It further improves accessibility and traceability of records, especially for audits and other regulatory inspections.

Adherence to Compliance Standards

Qualityze corrective action preventive action management software is designed in adherence with industry standards and best practices defined by the regulatory authorities including the Food and Drug Administration (FDA) – 21 CFR Part 820, International Organization for Standardization (ISO) – ISO 9001, ISO 13485 QMS software, Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA), China Food and Drug Administration (CFDA), etc.

User-Friendly Interface

Qualityze corrective action preventive action solution is a feature-packed and user-friendly software that makes it easy and convenient for novice users. With minimal training, your workforce can start managing quality processes more efficiently than ever. The intuitive interface often guides the user through the CAPA workflow and root cause investigation. Experience a simplified and straightforward approach to CAPA management with Qualityze smarter quality solutions.

Identifying and Eliminating the Root Cause with Effective CAPA Management Software System

With Qualityze CAPA Management System, you can identify the root-cause of the problems encountered in the quality management system. This further enables you to have a precise risk-assessment, based on which you can determine the right action plan for implementation to avoid the reoccurrence of the issue in the future. Ours is a feature-packed solution that comes with a user-friendly interface to handle CAPA with complete convenience and efficiency. You can document the quality issues, their potential risks, and decide on the action plan after complete analysis. However, the issue identified must be a valid nonconformance for risk assessment and an action plan to be implemented for the same. Get Qualityze CAPA Management Software solution today to treat nonconformance in a streamlined manner to avoid its reoccurrence. To fully understand the product’s functionality and features, you can request a free demo or submit a technical support request on our contact page and our team will get back to you at the earliest.