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Electronic Quality management

Electronic Quality management

This blog speaks about quality management info like non-conformance, audit management, CAPA,

What is an audit and how the components of an audit management software helps you in auditing

What is an Audit?

Examining of any process or system for its compliance with the given set of rules and regulations

Examining of any process or system for its Efficiency is called auditing

Its not an overnight process it has a set of systematic and holistic processes done simultaneously or sequentially to attain to a conclusion weather a system or process complies with the set of rules and regulations.

This depends on the volume of the the industry and people involved in the process

Audit management software system and its advantages

The 5 Steps of an audit includes 

  1. Finding and categorization of the audit based on function
  2. Planning and scheduling
  3. Preparation and conducting audit
  4. Documenting the audit
  5. Escalation to CAPA

An Audit management software system comes in handy if you are in a large scale industry and you are dealing with a huge systems and processes involving  set of people.

So, the question is how the components of an audit management software helps you in auditing.

An audit management system has components like

Risk Assessment

The risk profile of an audit is initially captured during the audit planning phase. The auditor further ensures that the risk is reviewed as per audit findings. The responses are then assessed and any CAPA actions taken are reviewed for risk mitigation.


This component will automatically notify the auditor and the auditees when the audits are due to be conducted, giving all parties time to prepare and make the audit exercise fruitful.

Conducting Audit

An Audit management software supports taking notes, documentation of findings, categorization of the relevant findings, etc. on-the-go.

Documentation of Audit

An Audit management software enables auditors to document any number of findings and categorize them accordingly. Findings can be flagged for follow-up, requiring a response from the auditee or even marked to require a CAPA.

CAPA Escalation

An Audit management system allows for findings to be categorized. Through this process, the findings that reach the critical threshold by policy can be required to have a CAPA. In such a state, the solution will allow the auditor to define the need for a CAPA plan and permit the auditee to submit the appropriate corrective and preventive plans. In addition, with the integration to CQ-CAPA management software  system, critical findings may also be grouped and addressed as a systemic CAPA.

With these components working in an automated work-flow achieves the desired audit output.

A forward thinking organisation always chooses a tool which can make their life easier and saves time, Audit management software is one such tool.

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