Webinar Alert: How Quality Compliance Drives Business Results

Discover your potential savings with our ROI Calculator

  Compliance Audit

Compliance Audit

compliance audit

What is it? What are some Best Practices to make it Effective? How to Run Compliance Audits that Drive Continuous Improvement (CI)?

A robust compliance audit process is needed to keep pace with regulatory changes, modify processes as needed, and ensure your QMS is up to date.

Request Demo
compliance audit

What is a Compliance Audit?

A compliance audit is a formal review of an organization’s procedures and operations, mainly focusing on whether an entity is complying with internal rules, regulations, policies, decisions, and procedures. An audit report will cover the resilience of compliance preparations, security policies, risk management processes, and user access controls observed during the audit.

What is the purpose of a Compliance Audit?

A compliance audit assesses how well an organization adheres to its internal bylaws, rules and regulations, standards, and even codes of conduct. An audit also reviews the effectiveness of an organization’s internal controls using multiple types of audits. External agencies, such as regulatory bodies, conduct compliance audits to assess a business’s adherence to regulations governing that industry.

  • Internal Audits: Internal audits enable an organization to follow processes, procedures, and guidelines. On the other hand, a compliance audit ensures that the organization is fulfilling outside obligations such as agreements, rules and regulations, or standards. Internal audits may be financial, operational, IT, or regulatory, but are conducted using formal audit approaches prior to an outside compliance audit to ensure that the organization is following the standards.
  • Compliance Audits: Compliance audits are different from internal audits. Compliance audits are outward-facing, ensuring that the company complies with regulations or codes of conduct. Both internal and compliance audit functions share the same language and even software to make sure that reviews are holistic.
  • Operational Audits: Operational audits identify how effective and efficient various departments and activities are and whether these areas operate in line with the mission and purpose of the organization.

Audit monitoring helps organizations to validate processes, including:

  • The security of critical data
  • The records of the financial departments
  • Health and safety
  • Payroll and HR policies
  • Management standards
history of compliance auditing

The history of Compliance Auditing

The regulations and compliance section grew mainly with the industrial age as governments, professional groups, and social welfare organizations desired enhanced monitoring and control over business practices. Beginning in the 1970s, internal auditing was created as companies wanted to ensure the integrity of their own practices. This was followed by a rise in government monitoring authorities as well as voluntary certification standards such as the ISO 9000.

Digitalization to Ensure Compliance

Digitalization to Ensure Compliance with Safety Training Standards

How are Compliance Audits conducted?

Conducting audits is about gathering and evaluating evidence, forming conclusions, documenting the audit process, and communicating with the auditable entities, and starts after finalizing an audit strategy and plan. In the planning phase, auditors review the internal controls and institutional arrangements to prevent, detect, and rectify instances of non-compliance before they start gathering audit evidence.

These are a few steps in a compliance audit:

  • After connecting with the auditor, the organization decides if the auditor’s expertise is a good fit.

  • At a preliminary meeting, the auditor explains the audit guidelines and what is required. The auditor may provide auditing checklists so that the client can prepare.

  • Once the organization completes audit questionnaires and supplies the auditor with the needed documents, the auditor may work on-site to view documents, walk through the workspaces, study infrastructure and security features, and interview management and employees.

  • The report should be delivered within a comparatively short time. At the final meeting, the auditor discusses the report and makes recommendations to address any areas of risk. Whether working under a regulatory deadline or not, organizations should generally rectify any deficiencies within 120 days to ensure that they have completed the corrective actions. Sometimes, auditing firms do follow-up support to help organizations rectify any risks or deficiencies. Auditors then validate and verify whether those measures have been met.



mustangbio case study

Customer Success

Biotech Company Partners with ComplianceQuest, Automates Quality Management Processes

mustangbio case study
Read Case Study
compliance auditing importance

The importance of Compliance Auditing

Compliance auditing, whether internal or external, enables a company to identify weaknesses in regulatory compliance audit processes and create ways for improvement. Sometimes, guidance determined by a compliance audit can help reduce risk while also avoiding potential risks or federal fines for noncompliance. Compliance auditing provides an outline of the internal business processes that can be improved or changed according to changes in regulations and requirements.


Contact Us

Internal vs. Compliance Audit

Internal audits are conducted by employees of a company to evaluate overall risks to compliance and security and to identify whether the company is following internal guidelines. Internal audits occur throughout the fiscal year, and reports can be used by management teams to recognize areas that require improvement. Internal audits measure company goals against output and strategic risks.

External audits, often referred to as regulatory compliance audits, are formal compliance audits that are performed by independent third parties and follow a specific format that is established based on the compliance regulation being assessed. Regulatory compliance audits gauge if an organization is complying with state, federal, or corporate regulations, rules, and standards. An auditor’s report is used by the C-suite to prove regulatory compliance or by regulators to review penalties for noncompliance. An external compliance auditor may use internal audits to assess compliance and regulatory risk management efforts.

internal vs. compliance audit
compliance audit procedures

Compliance Audit Procedures

External audits outline compliance checklists, guidelines, and the scope of the audit. The auditor investigates internal controls, conducts reviews of employee performance, evaluates documents, and checks for compliance in individual departments. Compliance auditors will primarily ask IT administrators and members of the C-suite certain questions, including who has left the company, what new users were added and when, whether employee IDs have been canceled, and which IT administrators have access to critical systems. IT administrators can develop compliance audits using robust change management software and event log managers to track and document authentication and controls in their IT systems. Auditors create a final audit report after reviewing business compliance processes as a whole. Compliance auditors provide comprehensive information to company leaders about the organization’s level of compliance adherence, any violations, and suggestions for improvement.

CQ Works Great and is a Pleasure to Use

We went live with CQ just a few weeks ago and it works great! We received excellent training and after some playing around and getting used to it we found that it is really easy to use. So far we have implemented Document and Training Management as well as CAPA and both have everything we need right out of the box. After years of cumbersome spreadsheets and databases CQ is a blessing. It makes document management quick and easy… and it’s a pleasure to use.

Helen Cary,
Document Control Specialist

LIN Engineering logo
LIN Engineering logo

What are some of the major challenges of compliance auditing?

Regulatory Affairs (RA) teams often struggle to keep up with new regulatory changes. This becomes even more challenging when the company is scaling up in newer geographies, and RA teams have to understand location-specific requirements.

Some of the biggest challenges when it comes to compliance auditing include:

  • Lack of clarity on new regulatory requirements
  • There is also the problem of a lack of data visibility from certain operational processes
  • It is not easy to seamlessly integrate people, processes, and systems, and the compliance audit process is not collaborative enough
  • Lack of transparency (of certain processes) and data traceability-related issues are also a challenge at some companies
  • Lack of an integrated document management solution, where audit leads are finding it difficult to locate documents on demand, leads to inefficiencies

Each of these challenges can be dealt with the help of a modern EQMS solution like ComplianceQuest with an integrated compliance audit management and inspection solution. With CQ, the entire workforce is digitalized, and an integrated Document-Training-Change (DTC) management solution comes in very handy for the auditors, quality teams, and regulatory leaders as well.

With AI and ML-enabled features, quality teams are able to automate the process of spotting similar audit findings and take corrective action as needed. CQ.AI’s Similarity Identification and Next-Best Action capabilities can be a game changer from a compliance audit standpoint.

Are you looking for an automated audit process to be in compliance with regulatory changes and modified processes? CQ’s compliance audit identifies weaknesses in regulatory compliance audit processes and creates ways for improvement.

Request a Personalized Demo



Quality-centric Companies Rely on CQ QMS

  • Flex
  • continental
  • 3m logo
  • YKK
  • Qorvo
  • Canon
  • Stryker
  • Lam Research
  • Just Evotech
  • Tilray

Frequently Asked Questions

  • The world’s largest dealer of construction equipment and heavy machinery streamlined health and safety processes with ComplianceQuest’s audit and inspection solutions within a day. The business was able to identify and improve site safety audits by adding ComplianceQuest’s modern and efficient audit management tool to streamline the process. A transparent site audit process was initiated with versatile and multi-language reports to increase proactiveness for safety issues. Thus, it results in reducing site safety inspection time by 93%.

  • A compliance audit should be conducted periodically and at key organizational milestones to ensure continuous alignment with applicable laws, standards, and internal policies. Generally, audits are performed:

    • On a scheduled basis — typically annually or biannually — to maintain ongoing compliance readiness.

    • Before certification or recertification audits, such as ISO, FDA, or HIPAA, to validate adherence to regulatory requirements.

    • After significant business or operational changes, including mergers, acquisitions, or system upgrades that may affect compliance.

    • Following incidents, customer complaints, or audit findings,, to assess the effectiveness of corrective actions.

    • When new regulations or standards are introduced, ensuring the organization is fully prepared to comply.


    Conducting compliance audits at these critical points helps organizations proactively manage risks, strengthen internal controls, and sustain regulatory and ethical integrity.

  • There are several types of compliance audits that organizations commonly undergo, depending on their industry and regulatory requirements. The most notable include:

    • HIPAA Audit: Ensures healthcare organizations protect patient data privacy and security.

    • PCI-DSS Audit: Verifies that businesses handling payment data maintain secure systems to prevent breaches.

    • SOC 2 Audit: Focuses on cloud service providers’ data protection practices covering security, confidentiality, and privacy.

    • SOX Audit: Required for public companies to ensure financial data accuracy, record management, and executive accountability.

    • ISO Audit: Evaluates compliance with international standards for quality, security, and risk management.

    • GDPR Audit: Confirms that organizations handling EU citizen data meet privacy and data protection regulations.


    These audits help organizations strengthen governance, protect data, and maintain regulatory compliance across various operational areas.

  • Compliance Audit Management is the process of planning, executing, and monitoring audits to ensure that an organization complies with internal policies, industry regulations, and legal standards. It involves documenting audit findings, managing corrective actions, and ensuring continuous compliance improvement through systematic oversight.

  • To perform effective compliance audit management:

    • 1. Define the audit scope and objectives.

    • 2. Develop a structured audit plan outlining timelines, responsibilities, and compliance criteria.

    • 3. Use automated tools to streamline documentation, evidence collection, and reporting.

    • 4. Identify and address nonconformities with corrective actions.

    • 5. Continuously monitor and improve compliance performance through periodic reviews.


    Platforms like ComplianceQuest help simplify this process with automation, real-time tracking, and integrated compliance workflows.

  • Preparing for a compliance audit involves a few key steps:

    • Identify applicable regulations and ensure your processes meet those requirements.

    • Schedule the audit in advance and organize all necessary compliance documents.

    • Conduct an internal review to identify and fix any gaps before the official audit.

    • Maintain detailed audit trails as proof of compliance and process accuracy.

    • Train employees to understand and follow compliance procedures.

    • Stay updated on changing regulations and industry standards.


    Following these steps ensures smoother audits and strengthens your overall compliance audit management process.

Mascot Astronut

Related Insights

Connect with a CQ Expert

Learn about all features of our Product, Quality, Safety, and Supplier suites. Please fill the form below to access our comprehensive demo video.

Mascot

Please confirm your details

spinner
Consult Now

Comments