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 […]
Audit Management: A Highly Integrated Approach to Manage Audit Findings and Drive Continuous Improvements
Audits are an inevitable part of a business’s risk management strategy, as they help identify and manage potential issues by assessing the quality of processes. However, the conventional methods of conducting audits are neither efficient nor compliance-friendly, and 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. Therefore, it is recommended that organizations upgrade to cloud-based audit management software to make their quality audits more efficient and productive.
Qualityze Audit Management enables end-to-end process management of both internal and external audits while managing compliance risks. Also, it fosters a culture of continuous improvement by ensuring timely audits. The advanced reporting tools provide auditors with better control over planning and executing audits while ensuring that 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 the 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
- Complete Closure
Audit Management Overview
It is no secret that regulatory requirements are becoming more stringent, and compliance costs are increasing. Additionally, audit management is becoming increasingly difficult as more audit types and numbers are required. Qualityze Auditing Management (QAu) software supports your regular audit management process. It enables you to improve quality, reduce costs, and recognize risk across the entire audit lifecycle, helping you to improve compliance and improve operational efficiency. With Qualityze Audit Management, you can effectively and efficiently:
- Manage Reusable Checklist Libraries
- Create Audit Plans
- Schedule Multi-Site Audits
- Manage Multiple Audit Programs
- Execute Audits and Track Findings
- Perform Follow-Ups / Closure
- Perform Digital Signature Validation
- Manage Audit Records
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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
Scheduling an Audit Plan
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.
Executing the Audit
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.
Why Audit Management Is Important?
Audit management is a quintessential process that ensures 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 Reduce Costs
- Gain Deeper Insights through Detailed Audit Results
How does Qualityze Audit Management Help Businesses?
Identify and mitigate quality issues while demonstrating to regulators that your quality policies are effective 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
With Qualityze Audit Management you can 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.
Drive Efficient Audit Processes
Qualityze Audit Management comes with pre-defined audit checklists that can be configured to suit your business-specific needs. You can also create an audit checklist using Microsoft Excel via the 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 users with the flexibility to conduct audits remotely.
The 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.
Manage Audit Findings
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 findings with high-risk for further investigation and 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 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 they are findings, best practices, or recommendations. This saves time and minimizes risk.
With Qualityze, auditors can quickly generate detailed audit reports and distribute them to all involved parties.
Integrate with Existing Business Systems
Qualityze Audit Management seamlessly integrates with all existing business systems and third-party applications such as CRM, ERP, LIMS, MES, and PLM currently used within the organization. The ability to collect data from different sources and applications reduces operational oversight 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!
Controlled Audit Records and Data
Qualityze Audit Management allows you to keep all audit observations and 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, Cannabidiol, Nutraceuticals, Biologics/Biotech, Food and Beverages, Automotive, Aerospace, Hospitality, Defense and Logistics. It allows you to manage multiple audit programs while demonstrating compliance with applicable regulatory standards.
Qualityze Audit Management Solution comes with a(n):
- Centralized Audit Database
- Pre-Defined Checklist
- Reporting and Dashboards
- Automated Email Approval
- Alerts and Notifications
- E-Signature
- Seamless Integration
- Chatter Platform
Qualityze EQMS – The Enterprise Quality & Compliance Management Platform – Plan, Manage, and Perform Quality Audits
Audit Management provides insights into potential quality issues that may result in nonconformances or noncompliance. Qualityze Audit Management makes this task easier and more 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 improvement. Our solution works as an effective audit management tool to ensure a proactive approach to managing risks, significantly improving 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 identifying and eliminating 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.
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