Audit Management

Essentially, audit management consists of several processes, procedures, and tools to help make the audit process easier for an organization to comply with the necessary regulations. 

Audit management enables businesses to handle the entire audit cycle from planning and scheduling an audit to managing documents and tracking corrective action. 

Audits are particularly crucial in regulated industries. While every business must conduct at least a financial audit, certain businesses might have to conduct multiple audits, especially if it is in the life sciences industry. They may also need to perform audits to meet standards set by ISO, US FDA, EMA, and MHRA and possibly schedule their own internal audits. 

Additionally, if a company operates in a regulated sector or if it operates in a larger marketplace, they may require more audits. If the business fails to meet regulatory compliance, then there will not be a product for them to sell. A company's success is based on whether or not they pass a regulatory audit.  

Challenges to Effective Audit Management 

The traditional approach to audit management comes with the following challenges: 

• Manual Data Entry: Using spreadsheets and paper documents opens doors to errors, and inconsistency with inefficient data entry and management.  

• Limited Visibility: Manual audits don't give you the level of real-time visibility into the audit process. It's hard for stakeholders to understand where an audit is and how it might affect them because they have no way to see the status of the audit procedures.  

• Compliance Risks: Not complying with industry regulations can result in huge fines, legal issues, and damage to your name and company.  

• Time and labor intensive: The amount of time, manpower, and resources your company spends on manual auditing distracts from your core business operations.  

Advantages of an Audit Management System 

There are many advantages to having an Audit Management System (AMS). Consider the following benefits: 

• Save time and resources: The right audit management software frees you and your team from mundane tasks so you can focus on resolving quality events and achieving business objectives. 

• Find everything in one place: Using AMS eliminates the need of several disconnected tools like a calendar, email, document organizer, and more because everything you require for an audit is available within the audit management software system. 

• Conduct Audits Remotely: Because of the pandemic, there is a rise in the use of remote auditing, and it will require Herculean effort to manage these audits without AMS. 

• Receive reminders: Any audit results may require corrective action. Following up on these actions can be quite stressful as there can be many people to follow up with. Using AMS will allow you to send reminders to all individuals responsible for implementing action plans to help relieve some of that stress and help hold them accountable for their inaction. 

• Foster transparency: The procedures are stored in one location, and the information cannot be altered. All documents, events, and CAPAs have audit trails containing a list of revisions, along with who created/edits/approves the document. As a result, each time a document is changed, the date and time are recorded to ensure data is protected and accurate in compliance with regulations established in 21 CFR Part 11. 

Effective audit management ensures traceability, timely closure of findings, and continuous improvement, while reducing inspection risk.