Audit Software

Buyers guide

Audit software helps organizations plan for, address and mitigate risks that could compromise the safety and/or quality of the goods or services they provide.

For businesses that adhere to government regulations and industry standards, audit management is a critical component of their compliance and risk management strategies.

If you’re considering investing in an audit management system, we’ve created this guide to help you make a more informed purchase decision. Here’s what we’ll cover:

What Is Audit Management Software?
What Are Common Features of Audit Software?
What Type of Buyer Are You?
What Are The Benefits of Audit Management Software?
Key Considerations for Audit Management Software

What Is Audit Management Software?

This type of software standardizes audit management processes across an organization. It helps automate the various steps in the audit lifecycle, allowing businesses to conduct audits in a single, comprehensive framework.

Although the types of audits can vary—internal audits, supplier audits, quality audits etc.—audit software commonly encompasses these steps:

Plan and schedule: Prioritize risk areas, create targeted risk-based plan, plan when the audit will happen. Schedule resources, create and assign tasks and checklists, assign owner.

Conduct audit: Owner and teams perform audit tasks, apply document controls, track observations and records findings. This stage is often described as “field work.”

Manage findings: Track progress, monitor trends and analysis. Develop audit reports, review recommendations with management and design risk management implementation plans.

Implement and review: Implement action plans, observe and record findings. Monitor and track success of action items and note any inconsistencies that might require future audits.

What Are Common Features of Audit Software?

Auditing systems typically include the following capabilities:

What Type of Buyer Are You?

As mentioned above, businesses that regularly require audits typically fall into two categories:

Regulated by the FDA. Examples include pharmaceutical companies following directive 21 CFR 211 and medical device firms that adhere to 21 CFR 820. These businesses have to follow these regulations exactly. To do so consistently and without error requires an automated system.

Complying with industry standards. Examples include general manufacturers and businesses in the service industry that follow quality standards, such as ISO 9000. To become ISO 9000 certified, businesses are assessed on their quality assurance practices and must submit documentation of their processes. Audit software can streamline this process.

What Are the Benefits of Audit Management Software?

Audit software can provide organizations with several benefits, including:

• Reduced risk. Standardizing audit management processes eliminates inconsistencies. It also provides visibility into workflows, data collection and report metrics.
 
• Enhanced security. Securely store and manage audit documentation, recommendations and implementation plans in a centralized system.
 
• Improved compliance. Comply with industry standards and government regulations while maintaining an accurate, searchable audit trail.

Key Considerations for Audit Management Software

When you’re evaluating potential audit management solutions for your business, start with detailing all your requirements and categorizing them based on their importance. Below are some parameters that will help you identify the right solution for you:

Automatic audit scheduling. Auditing a single process is relatively easy, but when there are thousands of processes across numerous locations and working areas, manual scheduling can be extremely difficult. Automatic audit management systems offer customized scheduling throughout the year based on factors such as the availability of auditors and the operational area. Automatic scheduling can help users map out their overall audit schedule for the complete year.

Convergence of safety and quality. The ability to integrate these two audit processes is an important consideration. Both share several common functions, such as document control and corrective action. On many occasions, for example, audit teams will review the corrective action process of environmental health and safety (EHS) systems but will do this at a later stage for quality management systems (QMS). Usually, both EHS and QMS have the same corrective action process, so, with audit management software, these can be managed in a single audit.

Mobility in the audit process. The audit process is usually conducted across an organization’s premises, including the warehouse and shop floor. It requires auditors to go to the physical location of each process and record the data. As such, there must be a mobile device, such as a tablet, to record data, especially in the case of cloud-based audit management systems. This feature allows the user to enter audit information into the system in real time.

Automated templates for checklists and audits. This feature speeds up the audit process without auditors having to compile checklists and type questions repeatedly. Most of the automated audit management solutions on the market provide a list of keywords that recognize several types of checklists and audits. With this feature, the user just has to choose the audit type to schedule the process, and the solution automatically pulls in the correct data.

Integration of audits with rest of QMS and EHS systems. Even if the overall audit process goes off smoothly, it will produce findings that require further action. Automated auditing solutions are usually included with QMS and EHS systems, and modern auditing systems automatically integrate with other quality and safety procedures, such as corrective action, to ensure complete transparency of information. You can also integrate audit findings to update all the records in document control and in training programs to make sure the staff is trained properly. Such integrations help management align the audit findings with the affected processes.