by Alexis Ferrier | Dec 8, 2021 | Audits, Compliance, Consulting Group, FDA, QMS, Quality, Quality Systems, Regulatory, Requirements, Standardization, Standards
An internal audit program is vital for proper monitoring and assurance of products. It is also essential to verify that individual processes reflect the current documented policies and procedures.
Here are five reasons why internal auditing is essential and its purpose in keeping companies and products compliant with regulations.
1.Provide objective evidence:
Auditing one’s work has a definite conflict of interest. An internal auditor or team of auditors without responsibility for the objective will provide objective evidence. It is adequate to cross-train employees in different departments to audit another department or consider hiring an auditor. The internal audit functions as a check for your product and helps add value to the process by providing an unbiased view.
2.Improve efficiency:
Internal audits improve efficiency by continuously monitoring and reviewing processes. It helps quickly identify control recommendations and improve the efficiency of operations.
3.Evaluate risks:
An internal audit program supports management in identifying and prioritizing risks through a risk assessment. A risk evaluation can help identify any environmental gaps and allow for a remediation plan. An internal audit program will help track and document any changes that have been made and ensure the mitigation of any found risks.
4.Assess controls:
Efficiency and Operating effectiveness are critical for any company. Internal auditing supports this by continuously improving the control environment.
5.Ensure compliance:
Performing an internal audit helps ensure compliance with any and all relevant laws and regulations. It can also help provide better preparation for the next external audit.
Any results of your internal audit should be analyzed and reported to management, typically during management review. All life science businesses should be conducting internal audits because it satisfies a regulatory requirement and acts as important continuous improvement tool. If you need help developing or implementing an internal audit program for your life sciences business, EMMA International’s team of experts can help. Give us a call at 248-987-4497 or email info@emmainternational.com
From EMMA international