The best way for a company to ensure that its quality system is adequate and effective is to perform an internal audit. The internal audit procedure is an independent examination conducted by an internal audit group that provides analysis of business structure, employee behavior and information systems designed to add value and improve an organization's operations. They are important components of a company's risk management, as they help companies identify issues before they become substantial problems. An internal audit checklist is also used to determine whether or not the subject of the audit is operating in compliance with governing source documentation such as corporate directives, federal and state environmental protection laws and regulations, etc.. The internal audit process must have trained and qualified people responsible for conducting internal audits, and who work in accordance with the Code of Ethics and the International Standards.
Sparta Systems' Internal Audit Software Solution
Sparta Systems' audit management solution also supports all internal auditing programs with a unique enterprise audit management approach. Internal audit software assists auditors to plan and execute internal audits more efficiently by providing an integrated tracking system and a powerful workflow engine that automates all steps in the audit lifecycle, including scheduling, preparation, auditing, report approval, report issuance, response and corrective action (CAPA) tracking.
- Provide visibility to executive management through a standard automated internal audit report
- Facilitate compliance with global government regulations and industry standards
- Gauge continuous internal audit process improvement efforts and measure the return on investment for sustaining those efforts
Requirements to Meet Internal Auditing Standards:
- AATB B2.124 Quality Assurance Program
- FDA 21 CFR 1271.160 Establishment and Maintenance of a Quality Program (c)Audits
An Effective Tool for Managing Any Type of Audit Including:
Business Conduct Standards
Clinical Support Audits
Internal Quality Audits
Internal Facility Projects
Method Validation Audits