Regulatory Audits: How to Do Them Right and Turn Compliance into a Competitive Advantage

A regulatory audit rarely fails because of a lack of effort. In reality, it usually falls apart due to missing or weak evidence: outdated documents, incomplete records, broken traceability, approvals without an audit trail, multiple versions in circulation, undocumented training, or ignored retention requirements.

The good news is simple: succeeding in a regulatory audit does not depend on memorizing answers. Instead, it depends on building a reliable and repeatable document management system where anyone, including an auditor, can quickly locate, understand, and verify how the organization operates and how risks are managed and controlled.

That’s why this McFile guide lays out a practical, step-by-step approach to help you:

Understand what regulatory auditors look for — and why;
Organize documents and records using an evidence-based structure;
Implement essential controls, including version control, access control, audit trails, and retention policies;
Train teams to respond consistently;
Conduct audit readiness reviews (mock audits) and address findings through CAPA (Corrective and Preventive Actions);
Come out of the audit with continuous improvement — not just a sense of relief.

Why documentation determines the outcome of an audit

First and foremost, it’s important to remember that auditors assess compliance and an organization’s ability to maintain control. To do so, they require evidence that demonstrates what was planned, executed, reviewed, and improved.

In management systems, this principle is clearly reflected in ISO 9001’s requirement for the control of documented information, which defines how documents and records must be created, updated, protected, and made available.

Beyond that, there is an often overlooked factor that weighs heavily on audit day: the time spent searching for information. Widely cited studies show that employees spend a significant portion of their workday looking for data, which, during audits, translates into stress, delays, and inconsistent responses when evidence is fragmented across systems and locations.

In practical terms, the takeaway is straightforward:

When an organization has to hunt for evidence, the audit quickly becomes a stress test.
By contrast, when information is organized and properly governed, the audit becomes a largely administrative exercise: locate, present, and explain.

What regulatory auditors typically assess (and how they think)

In general, the audit approach follows a fairly clear sequence:

What is the requirement? (law, standard, regulation, or internal policy/procedure)
How was the process designed to meet that requirement?
What evidence demonstrates that the process actually occurred as described?
How does the organization ensure data integrity, traceability, and control over time?
How are issues corrected and prevented from recurring in the future?

Audit ≠ inspection (but in practice, they often look similar)

While audits focus on systems and processes, and regulatory inspections tend to emphasize risk and point-in-time compliance, both require robust evidence and end-to-end traceability.

As a result, in regulated sectors in Brazil such as healthcare, sanitary surveillance, laboratories, and medical devices, official regulations and guidance from Anvisa (Brazil’s health regulatory agency) make it clear that the focus is on Good Practices and objective evidence of compliance with requirements.

The seven most common pitfalls that derail audits (and how to fix them)

1) Documento “certo”, versão errada

Symptom: The procedure has been updated, but operations are still using an outdated copy.
Fix: Version control, automatic deprecation of outdated versions, and a single source of truth.

2) Incomplete or inconsistent records

Symptom: Missing fields, dates, or signatures.
Fix: Standardization, validation rules, and a clear audit trail.

3) Scattered evidence

Symptom: Evidence spread across email inboxes, personal folders, shared drives, or messaging apps.
Fix: A central repository, a clear information taxonomy, and intelligent search.

4) Informal approvals

Symptom: “Management reviewed it,” but there is no documented evidence.
Fix: A formal review and approval workflow with logged evidence.

5) Broken traceability

Symptom: The organization fails to link requirement → process → evidence.
Fix: A compliance matrix and clear links between documents and records.

6) Training without documented proof

Symptom: Training was delivered, but there is no attendance record, assessment, or formal acknowledgment.
Fix: Structured training records with documented evidence and defined validity periods.

7) Weak CAPA

Symptom: Issues are corrected, but recurrence is not prevented.
Fix: Root cause analysis, a structured action plan, documented evidence, and effectiveness verification.

Regulatory audit readiness: a step-by-step playbook

After understanding what auditors assess and the most common pitfalls, the next step is to structure your audit preparation in a systematic way. The more predictable this process is, the lower the risk on audit day.

Below is a practical audit readiness model focused on evidence, control, and organization.

Step 1: Define the scope, requirements, and expected evidence

Before organizing any documents, it’s essential to answer a few fundamental questions:

Which audit will be conducted? (regulatory authority, standard, customer, or certification)
Which areas, processes, and business units are in scope?
Which requirements apply? (laws, standards, regulations, and internal policies or procedures)
What type of evidence demonstrates compliance with each requirement?

This initial alignment helps avoid two common problems: overworking on areas that won’t be audited, while leaving critical gaps without supporting evidence.

In practice, more mature organizations explicitly map requirements to evidence, making both audit preparation and auditor responses much easier.

Step 2: Organize documents and records

Auditors don’t want to see “well-organized folders.” They want to see document control and consistency between what is documented and what was actually executed.

That’s why it’s important to reinforce a classic distinction:

Documents define how a process is supposed to work (policies, procedures, and instructions).
Records demonstrate that the process actually took place (checklists, reports, completed forms, approvals).

When documents and records are centralized in a DMS like McFile, it becomes much easier to:

Ensure that only the current, approved version is in use;
Maintain a complete version history and editorial traceability;
Reduce the risk of evidence being scattered across emails or personal folders;
Enable fast access to the right information during the audit.

Step 3: Ensure information control, traceability, and integrity

In regulatory audits, simply presenting a document or record is not enough. Auditors typically want to understand:

Who created or modified the information;
When those actions took place;
Whether the information was reviewed or approved;
Whether the version presented was valid at that point in time.

Controls such as version control, audit trails, formal approval workflows, and role-based access control help support these answers with objective evidence rather than verbal explanations alone.

In practice, this level of control reduces follow-up questions, rework, and the need to “justify” processes during the audit.

Step 4: Centralize documents and avoid content outside the system

Many audit issues begin when evidence lives outside formal control, such as emails, loose attachments, or informally shared files. In practice, this happens because documents arrive through multiple channels in day-to-day operations and end up scattered, without a single place that holds the correct version.

When this happens, the organization wastes time trying to locate files, confirm whether they are up to date, and reconstruct the context around the information. As a result, during the audit, this effort shows up as delayed responses, inconsistencies, and lack of confidence when presenting evidence.

For this reason, rather than trying to control every point of entry, it’s essential to centralize documents once they arrive. Document management solutions like McFile address this challenge by bringing files from different sources into a single environment, with version control, change history, and access permissions.

As a result, instead of chasing scattered documents, the audit becomes far more predictable. Evidence is already organized, contextualized, and ready to be located and presented when requested.

Step 5: Ensure version control and a reliable document history

One of the most sensitive issues in regulatory audits is the use of incorrect document versions. Even when a procedure has been updated, it’s not uncommon for outdated copies to remain in circulation, creating uncertainty about which version was valid at the time the process was executed.

For this reason, auditors don’t assess document content alone. They also evaluate the organization’s ability to demonstrate which version was in effect at a given point in time and what changed over time. Without this level of control, the evidence loses credibility.

In this context, version control stops being just an organizational practice and becomes a regulatory requirement. DMS solutions like McFile help address this challenge by clearly identifying the current approved version while preserving a complete change history. This makes it possible to see who modified a document, when the change occurred, and which versions existed previously.

In practice, a reliable document history reduces questions during the audit and avoids unnecessary discussions about document validity. Instead of explaining “which version counts,” the organization can simply demonstrate control, signaling maturity and confidence to the auditor.

Step 6: Formalize reviews and approvals

Another critical point in regulatory audits is how reviews and approvals are handled. In many organizations, important decisions are still made informally, through verbal confirmations or email exchanges that leave no clear record. From an auditor’s perspective, however, an approval without evidence simply does not exist.

For that reason, beyond version control, it’s essential to demonstrate that documents went through proper review before being used. Auditors typically want to see who reviewed the document, who approved it, and when that happened—especially for documents that directly impact regulated processes.

In this scenario, formal review and approval workflows make a real difference. In a DMS like McFile, these workflows turn approvals into objective evidence by recording responsible parties, timestamps, and process steps. In practice, this level of control reduces audit questions and avoids debates about “who approved” or “whether it was validated.” Instead, the evidence is documented, linked to the correct file, and readily available whenever needed—bringing greater predictability and confidence to the audit process.

Step 7: Control access and preserve traceability

In regulatory audits, it’s not enough to prove that information exists and is accurate. You also need to demonstrate that access to that information is controlled and that actions taken on documents can be traced over time. This typically comes up when auditors ask who is allowed to access, modify, or approve specific content.

When access control is unclear, questions arise around data integrity and segregation of duties. In addition, without traceability, it becomes difficult to explain how a document evolved or who interacted with it during a specific period.

For this reason, permission management and the preservation of action history are essential parts of audit readiness. DMS solutions like McFile allow organizations to define access profiles, restrict actions based on user roles, and maintain records of key interactions with documents. In more structured environments, integrations such as SSO also help strengthen access governance and security.

In practice, this set of controls builds confidence with auditors. Instead of relying on verbal explanations, the organization can demonstrate that access to information is intentional, monitored, and aligned with defined responsibilities—strengthening its regulatory evidence.

Step 8: Prepare people to respond with evidence

During the audit, how people respond to questions is just as important as the documentation itself. Long answers based solely on memory, or with different interpretations across teams, tend to create doubts and trigger additional requests for evidence.

For this reason, teams should be guided to respond objectively, always pointing to the document or record that demonstrates compliance with the requirement. When evidence is organized and easily accessible, this approach becomes much simpler and more consistent.

Step 9: Treat audits as an ongoing practice, not a one-time event

Regulatory audits tend to be more challenging when they are treated as isolated events. In that scenario, preparation turns into a race against time, decisions are made under pressure, and the organization operates in a reactive mode.

On the other hand, when audits are treated as part of day-to-day management, the process becomes far more predictable. Documents are already organized, versions are under control, and evidence remains available over time—without the need for last-minute fixes.

In this context, document management stops being a one-off support function and becomes the foundation for sustained regulatory control. With history preserved and consistent access to information, future audits require less effort and create far less friction.

In practice, this approach allows audits to fulfill their primary purpose: identifying opportunities for improvement and strengthening processes, rather than simply pointing out issues under pressure.

What an audit really reveals about your organization

A regulatory audit doesn’t just test documents—it reveals how the organization actually operates day to day. In other words, it shows whether processes are supported by clear evidence or still rely on lengthy explanations, manual effort, and last-minute fixes.

When document management works as it should, the tone of the audit changes completely. The team can quickly locate information, present the correct versions, and support decisions without hesitation. As a result, auditors see control, consistency, and process ownership—instead of improvisation.

Beyond that, this level of organization isn’t just about “passing” an audit. In reality, it reduces risk, eliminates rework, and improves operational efficiency. As a result, compliance stops being a purely defensive obligation and becomes a driver of better decisions and more predictable processes.

That’s exactly where electronic document management plays a strategic role. Instead of simply storing files, it ensures the right information is organized, at the right time, and available to the people who actually need it.

McFile. Drive your efficiency.