Qualityze Achieves ISO 9001:2015

Tampa, FL – January 30, 2020 – Qualityze, Inc. has been certified as ISO 9001:2015 – compliant after an in-depth audit of the company’s internal operations.

Audit Management : A Highly Integrated Approach to Manage Audit Findings and Drive Continuous Improvements 

Audits make an inevitable part of business’ risk-management strategy. It helps identify and manage potential issues by assessing quality processes. The conventional methods of conducting audits are neither efficient nor compliance friendly. One of the significant challenges for organizations is managing decentralized audit systems. It becomes difficult for them to perform detailed analysis and make informed business decisions. That’s why organizations should upgrade to cloud-based audit management software to make their quality audits truly efficient and productive.

Qualityze Audit Management enables end-to-end process management of internal and external audits while managing compliance risks. It fosters a culture of continuous improvements by ensuring timely audits. The advanced reporting tools provide auditors better control on planning and executing audits while ensuring every process is aligned with current guidelines.

With Qualityze Audit Management Software you can streamline processes to:

  • Define Audit Criteria via Checklists
  • Plan the Audit (Based on Audit-Type and Frequency)
  • Schedule the Audit
  • Prepare for Audit
  • Execute the Audit & Report Observations
  • Track Audit Findings
  • Ensure Effective Action Plan for Findings
  • Conduct Follow-Up Activity
  • Perform Effectiveness Check of Actions Taken
  • Closure

Audit Management Overview

As we all know, regulatory requirements are becoming more stringent, and the cost of compliance is growing. At the same time, audit management is becoming increasingly challenging, given the number and types of audits that need to be conducted. Qualityze Auditing Management software (QAM) complements your established audit management process and empowers you to improve quality, reduce costs and identify operational and compliance risks by effectively managing the full audit lifecycle.

  • Reusable Checklist Libraries
  • Creating an Audit Plan
  • Audit Program
  • Executing Audit
  • Track findings
  • Responses
  • Performing Follow-Up / Closure
  • Digital Signature
  • Audit Trail
  • Notification & Alerts
  • Scheduling an Audit Preparing an Audit

audit and risk management software
audit management system process

Creating an Audit Plan

Creating an audit plan is the first and foremost step in the auditing process. It serves the auditors to define the objective, scope, criteria, location, and the establishment of an overall audit strategy.

The audit management and tracking software from Qualityze help to streamline the audit plan. You can use the Audit Type template to define the relevant information such as:

  • Title
  • The Scope of the audit
  • The Objective of the audit
  • Audit Criteria
  • Checklist
  • Lead Auditor
  • Checklist
  • Lead Auditor
  • Audit Team
  • Location
  • Type of Audit and others
  • Audit Schedule
quality audit management system

Scheduling an Audit Plan

iso audit management software

The audit schedule is a specification of the planned activities that will occur over a certain period e.g., yearly, half-yearly, quarterly, etc. Most companies develop an annual schedule, usually for internal and supplier audit program. However, there could be any number of audits scheduled in an organization.

Qualityze Audit Management allows organizations to schedule their online as well as offline audits quite conveniently and efficiently.

Preparing For Audit

In Qualityze, Audit Program (AP) will help you to set up a yearly plan for internal and supplier audit program in conjunction with an Audit Type. In the Audit Program you can define:

  • Auditors and the Auditees
  • Audit Start/End date
  • Predefined Audit Questionnaire
  • Audit Standards
  • Audit Criteria and Others
  • Prepare and Execute Audit

After defining all the elements of the Audit Program, the next step calls for the lead auditor to confirm and update the audit. The auditee and auditor should agree on the objective, scope, criteria and start date of the audit process.

internal audit management software

Executing the Audit

internal audit management software systems

Once you are done with the creation of the Audit Type and Audit Program, the advanced system of Qualityze will automatically notify you in advance to prepare for the audit. You also have an option to update the individual audit for information such as:

  • The Scope of the audit
  • The Objective of the audit
  • Audit Criteria
  • Checklist
  • Lead Auditor
  • Audit Team
  • Location
  • Type of Audit and others

If there are multiple auditors performing the audit, you as a lead auditor can assign individual checklist to each auditor in the team.

Track Findings

During the audit, any observations – whether it is non-conformance or need better practices – needs to be recorded and tracked till completion.

In Qualityze’s Audit Management System, observations are categorized into three terms: Findings, Positive Practices, and Recommendations. The system allows you to define these observations at an individual level as well. When you categorize observation as Findings, you have an option to follow the workflow to address it. Every Finding is assigned a unique number for you to keep track off until it is closed.

Audit Management Software Systems

Why Audit Management Is Important?

Audit management is a quintessential process to ensure that all audit directives are correctly implemented and executed. It encourages any organization to:

  • Improve Audit Plans
  • Track and Manage Audit Findings
  • Boost Audit Efficiency and Cut Costs
  • Gain Deeper Insights through Detailed Audit Results

How does Qualityze Audit Management Help Businesses?

Identify and mitigate quality issues while demonstrating regulators that your quality policies are efficacious by creating effectiveness checks with Qualityze.

With Qualityze Audit Management, you can:

  • Implement Industry Best Practices for Audits
  • Drive Efficient Audit Processes 
  • Manage Audit Findings
  • Get Greater Visibility into Audit Results
  • Integrate with Existing Business Systems
  • Drive Continuous Improvements
  • Controlled Audit Records and Data

Implement Industry Best Practices for Audits

Internal Audit Tracking Software

Qualityze Audit Management allows you to manage the end-to-end audit process by creating standardized workflows. You can track audit activities through intuitive dashboards to monitor their progress. You can plan, manage, and conduct all types of audits, including Internal, External, Third Party, Ad-Hoc, Regulatory, Supplier, IT, and Offline Audits quarterly, bi-annually, and annually.

With Qualityze, you get the pre-defined audit checklists to stay compliant with applicable regulatory standards. You can also configure and add new fields in the checklists to suit your business requirements. Having standardized processes and documents ensure that your organization has implemented best practices for audits globally.

Drive Efficient Audit Processes 

Qualityze Audit Management comes with pre-defined audit checklists that can be configured to suite your business-specific needs. You can also create an audit checklist using Microsoft Excel via Qualityze import function. Our solution allows you to schedule audits, reviews, approvals, alerts, email notifications, and follow-up activities to ensure efficient audit processes; thereby, reducing cycle times. The cloud platform provides the user flexibility to conduct audits remotely.

Qualityze Audit Management configurable workflow streamlines the audit lifecycle. It allows auditors to create an audit plan or audit program by capturing details such as Title, Scope, Objective, Audit Criteria, Lead Auditor, Audit Team, Location, Type of Audit, and Owner.

Audit Management and Tracking Software

Manage Audit Findings

Audit Management and Tracking Software Systems

Qualityze Audit Management has a user-friendly interface that allows you to capture and manage audit findings, communicate corrective actions effectively, and ensure compliance while mitigating risks. You can escalate the findings with high-risk to further investigation. You can manage multiple audit findings and their responses simultaneously.

With Qualityze, you can create a closed-loop workflow to address audit findings. Each finding is assigned with a unique reference number to track the progress of the record until its closure.

 Get Greater Visibility into Audit Results

Qualityze Audit Management has powerful reporting capabilities to provide greater visibility into critical audit results – whether it is Findings, Best Practices, and Recommendations that saves time and minimizes risk.

With Qualityze, auditors can quickly generate detailed audit reports and distribute them to all the involved parties. You can produce different types of reports for different types of audits, each providing you valuable insights. Increased visibility of audit reports and results helps you make informed business decisions on the required improvements and changes.

Audit Management Systems

Integrate with Existing Business Systems

Audit Management System Software

Qualityze Audit Management seamlessly integrates with all the existing business systems and third-party applications such as CRM, ERP, LIMS, MES, and PLM that are being currently used within the organization.

The ability to collect data from different sources and applications reduces operational oversights and ensures a smarter decision-making system.

Integrating Audit Management with existing systems enables your auditors to perform a thorough analysis, manage risks, and ensure excellence.

Drive Continuous Improvements

Qualityze Audit Management helps manage audit programs, findings, and action plans, allowing auditors to track KPIs that drive continuous improvement. The Follow-Up feature enables you to keep track of the action plan being implemented to reduce recurring findings. You can also track the history of audit records to plan for future audits.

Drive a culture of quality and continuous improvements with Qualityze!

Audit Management Solutions

Controlled Audit Records and Data

Audit Management and Tracking Software

Qualityze Audit Management allows you to keep all audit observations and the relevant action plans documented and securely stored on a centralized cloud platform. Keeping your audit processes documented helps maintain strict compliance with regulatory standards, including FDA 21 CFR Part 11, EU Annex 11 and ISO (e.g., digital records, electronic signatures, record retention periods, etc.).

Qualityze Audit Management – Managing End-to-End Audit Processes

Qualityze Audit Management works for every industry, including –Manufacturing, Life Sciences, Pharmaceuticals, Medical Devices, Cannabis/Hemp/CBD (I.e. Cannabidiol), Nutraceuticals, Biologics/Biotech, Food and Beverages, Automotive, Aerospace, Hospitality, Defense and Logistics, to manage multiple audit programs while showing compliance with applicable regulatory standards.

Qualityze Audit Management Solution comes with:

  • Centralized Audit Database
  • Pre-Defined Checklist
  • Reporting and Dashboards
  • Automated Email Approval
  • Alerts and Notifications
  • E-Signature 
  • Seamless Integration
  • Chatter, and more.

Qualityze EQMS – The Enterprise Quality & Compliance Management Platform – Plan, Manage, and Perform Quality Audits

Audit Management provides insights to potential quality issues that may result in nonconformances or noncompliance. Qualityze Audit Management makes this task easier and efficient by standardizing all audit-related processes while complying with the regulatory standards. The pre-defined checklists, audit scheduler, alerts and notifications, reporting, and dashboards accelerate audit cycle time, driving a culture of continuous improvements. Our solutions work as an effective audit management tool to ensure a proactive approach for managing risks that significantly improves product quality, safety, and global compliance.

Qualityze EQMS Suite helps enterprises align their critical processes with business quality objectives while mitigating operational challenges. Built on the most powerful and secure cloud platform, Salesforce.com, Qualityze provides unparalleled cloud benefits to manage online and offline audits. We empower you to optimize your quality processes by giving you more control and confidence in addressing compliance, quality, and operational risks efficiently through regular audits, allowing you to focus on your business growth opportunities.

Qualityze prepares you to succeed with a next-generation approach to identify and eliminate inconsistencies throughout the quality system, products, and processes.

Experience Qualityze Difference to Optimize Quality

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

Configurable Cloud-Based Platform

Qualityze Audit Management System is a next-generation solution that comes with an easy-to-use and intuitive interface. This cloud-proven software allows organizations to have better control and management of their internal and external audits as and when required with its configurable structure.

Adherence to Compliance Standards

Qualityze Audit management system is aligned with all the latest standards including the Food and Drug Administration (FDA) – 21 CFR Part 820, International Organization for Standardization (ISO) – ISO 9001, ISO 13485, Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA), China Food and Drug Administration (CFDA), etc. to enable organizations with superior quality maintenance systems.

User-Friendly Interface

Qualityze Audit Management Software and Tracking System comprises a user-friendly interface that eases for auditors to conduct timely and effective audits even if they are don’t have technical expertise. Our end-to-end audit management solution helps you ensure quality aligned with compliance.

Transforming the Way Organizations Conduct Their Internal and External Audits

Audit Management System Software from Qualityze helps you to manage end-to-end auditing processes while ensuring that compliance directives are met. Our solution empowers your existing audit processes with detailed insights through its powerful analytics and reporting feature so to prevent any impact on the product quality to be delivered to the customers.

Ours is a cost-effective, next-generation ISO audit management system that keeps the processes of internal and external audits in a loop to get in-depth audit results. These results will further help you make an informed decision – whether there is a need to initiate CAPA for products or processes to ensure quality of the deliverables.

Lacking the insightful audit findings due to an unorganized management process? Get Qualityze Audit Management and Tracking Software to keep your audit management processes in order and aligned with the compliance standards. You can check out the product’s functionality and features yourself. Just request a product demonstration today. To know more about our qms software, get in touch with us on our contact page and we will get back to you at earliest.