The Best Quality Audit Management Software for Life Sciences

April 11, 2024

Quality audits are a good thing. They keep us on track for business and regulatory compliance purposes, and ensure the integrity and safety of our products. But quality audits can be complex and even overwhelming, especially if your life sciences business is using several different methods to collect and share information.

Quality audit management software takes the stress out of audits by centralizing quality management processes and documentation. Quality audit management software gives you clarity and control by making data collection, routing, storage and reporting automatic. Audit managers are able to easily schedule audits, access and share the most up-to-date information, and follow up and report on any findings. We’ll give you an overview of quality audit management software and offer up five of the best quality audit management software options available in 2024.

What is audit management software?

Audit management software facilitates every stage of the audit process, from planning and scheduling to generating final reports, thereby improving the efficiency and accuracy of the audit process. It automates the process of preparing and executing audits by helping life sciences companies analyze data, assess risks, track issues, report results and centralize documentation. Regulatory compliance is streamlined and simplified by centralizing workflows with full traceability

Why do life sciences companies need audit management software?

Life science companies are required to follow strict rules established by the U. S. Food and Drug Administration (FDA) as well as the International Organization for Standardization (ISO). Because life science companies directly affect human health and safety, it is important they maintain FDA and ISO compliance. Audits are required by the standards, whether it is ISO 13485 or the FDA QSR. So why manage compliance standards manually? The standards help ensure that products are safe and effective for consumers. Audit management software makes it faster and easier to track these requirements.

The FDA requires software solutions to be validated. When an FDA-regulated company demonstrates and verifies that their software can accurately and consistently provide results that meet established compliance and quality management criteria, this is known as FDA software validation.

Planning and Scheduling

With audit management software, life sciences organizations can create automatic processes and checklists based on business goals or compliance requirements. Some audit management software offers pre-built checklists based on common regulations, such as ISO 9001 or FDA 21 CFR requirements. Audit management software can automatically schedule audits and generate reminders and alerts for upcoming audits, so you can be prepared.

Audit Execution

When audit time rolls around, documentation is easy to find because it is centralized within the audit management software. Documentation can then be easily shared with auditors via the software or by email/download. Any audit findings can be easily linked with corrective actions and linked to other related functions, such as employee training and document management.

Reporting and Follow Up

Audit management software offers robust reporting capabilities using real-time data culled from the system with the ability to attach outside files. Audit findings can automatically trigger a response and record corrective actions, as well as record and generate reports once the findings are addressed.

Supplier Audit Management

Good audit management software integrates all automated audit processes with supplier data, including documentation and supplier corrective actions.

Quality Audit Management Software Integration

Quality audit management software is when audit management is included as part of Quality Management System (QMS) software. Using QMS software with audit management built in offers a multitude of benefits beyond simply automating the audit process.

Some of the key benefits:

Seamless Data Flow: Siloed information hinders effective auditing. Integrating audit management with your QMS removes these silos. Audit findings, corrective actions, historical data and nonconformance reports are readily accessible within a central platform, enabling auditors to gain a holistic view of an organization's quality performance.
Enhanced Risk Management: A well-integrated system allows for proactive risk assessment. Audit management applications can analyze trends and patterns in data culled from your QMS, pinpointing areas susceptible to nonconformities. This empowers management to prioritize audits and address potential issues before they escalate.
Streamlined Corrective Actions: When a nonconformity is identified during an audit, the integrated system allows for immediate creation of corrective action plans. These plans can then be assigned to relevant personnel, ensuring timely and effective resolution.
Improved Communication and Collaboration: Communication breakdowns often plague traditional audits. QMS audit management integration fosters complete exchange of information. Auditors can share observations and findings directly within the system, while management can provide feedback and updates on corrective actions in real time.
Dedicated Audit Trail: A complete audit trail is critical for maintaining transparency and accountability. Integration ensures that a comprehensive record of all audit activities is maintained within the QMS, including audit reports, corrective action plans and communication threads.
Data-Driven Decision Making: The integrated platform becomes a goldmine of valuable data. By analyzing combined QMS data, management can identify trends, measure the effectiveness of corrective actions, and make informed decisions about process improvements and resource allocation.

Business Benefits of Audit Management Software

Audit management software can go beyond simply managing audit processes to offer insights into work practices and ways life science companies can improve business operations. When integrated with QMS software, audit management applications can quickly identify nonconformances, highlight areas of good practice and provide evidence of conformance in real time.

Major business benefits include:

Enhanced Audit Quality: With increased efficiency, standardized procedures and real-time data access, audit management software empowers auditors to conduct higher-quality audits that yield more insightful and actionable results.
Reduced Costs: Automation of repetitive tasks and improved communication through integration can lead to significant cost savings. Not to mention that less time is wasted on administrative tasks and resources can be better directed towards value-added activities.
Faster Issue Resolution: Early identification of nonconformities and efficient communication channels facilitate quicker resolution of issues and minimize potential disruptions to your production process.
Continuous Improvement: Data-driven insights from integrated audits provide a clear roadmap for continuous improvement. Organizations can identify areas for improvement and implement changes based on real, impactful data.
Increased Productivity: By automating many of the mundane tasks associated with audits, audit management software frees up valuable time for staff and auditors to focus on higher-level analyses and problem-solving.

Compliance and Audit Management Software

The chief benefit derived from audit management software is simplified, improved regulatory compliance. Effective audits with clear documentation and an action plan that is easy to follow and track, demonstrate a commitment to compliance with regulatory and industry standards.

Integrated systems make it easier to maintain audit records and provide data to back up compliance efforts. Historical audit reports are easy to access and share. Audit processes built into everyday quality tasks show a commitment to continuous improvement as well as optimize resources for efficiency and better use of resources.

See below for audit management software that can help you be your best - for your auditor and your life science organization.