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Qualityze EQMS

With the regulatory requirements becoming more stringent, the cost of compliance is also growing for the companies. This, as a result, has made audit management even more challenging, given the number and types of audits that need to be conducted.

Qualityze Audit 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 by:

  • Creating an Audit Plan
  • Scheduling an Audit
  • Preparing an Audit
  • Executing Audit
  • Track findings
  • Performing Follow-Up / Closure

Qualityze audit management software system is flexible and highly configurable. It is nimble and adaptive to various types of audits including Internal, External, Third Party, Ad-Hoc, Regulatory, Supplier, IT.

Qualityze audit management and tracking software system is integrated with powerful analytics and reporting capability for compiling audit reports, easy status tracking, analyzing auditor performance, and audit results. The interactive executive dashboard provides meaningful audit statistics to c-level management to make informed decisions.

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
  • 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 of the companies develop an annual schedule usually for internal and supplier audit program.

Preparing an 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.

Industries Qualityze Offers Audit Management Implementation for.

Qualityze Audit Management System works for different industries with the same effectiveness and efficiency. From General Manufacturing to Life Sciences, Pharmaceuticals to Healthcare, Biotech to Metal Manufacturing, Heavy Machinery to Food and Dairy, Automotive to Aviation or Aerospace, Defense to Medical devices, Logistics to Nutraceuticals, our solution makes it easy for your workforce to manage and control audits while maintaining the topmost quality standards with

  1. 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.

  1. 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.

  1. 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.

 Why Audit Management is Important?

Audit management is quintessential process to ensure that all the audit directives are correctly implemented as stated in compliance. It encourages any organization to:

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

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 products, get in touch with us on our contact page and we will get back to you at earliest.

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