Audits are a routine part of quality management in life sciences, but they don’t have to be disruptive. When your team adopts consistent audit best practices and uses your eQMS effectively, quality audits become less stressful, more predictable, and a welcome catalyst for improvement.
Whether you’re preparing for a customer audit, regulatory inspection, or internal quality review, the right systems and structure can make all the difference. This blog outlines practical audit best practices rooted in everyday use of your electronic quality management system (eQMS). The goal is to help your team prepare for audits year-round, not just during crunch time.
Before preparing for an external inspection, quality teams should start by looking inward. Internal audits, when treated as more than a formality, can reveal where things are working well and where adjustments are needed long before an auditor walks in.
These pre-audit exercises are most effective when they simulate real audit conditions. Walk through the full inspection flow: navigate your eQMS, time how long it takes to retrieve documents, review CAPAs, and practice audit Q&A. This approach helps quality teams build confidence and spot potential blind spots early.
Just as important is to understand, broadly, how your organization works. Who owns which processes? Why are they carried out that way? What evidence supports compliance? Building this internal awareness helps your team provide the right information clearly and quickly.
Quality teams should meet regularly with subject matter experts (SMEs) across departments to clarify roles, understand critical workflows, and align quality expectations. The more you understand how each team operates, the better you can support them and answer auditor questions with clarity and confidence.
Most QMS software helps you manage documents, training, and quality events, but not all systems make audits easier. Whether you’re selecting a new eQMS or looking to get more from your current one, it’s worth focusing on the features that directly support smoother, faster audits.
Here are some audit-friendly eQMS capabilities to look for:
When an auditor asks for a specific Standard Operating Procedure (SOP), the ability to search by keyword, filter by document type, and instantly pull up the latest approved version can make or break your response time. An audit-ready Documents Module should be able to:
Example: If an auditor requests a specific SOP, you should be able to locate it within seconds, complete with approval signatures, training, and revision history.
Setting goals around document management, such as reducing overdue reviews or increasing on-time approvals, can help keep your system audit-ready throughout the year. (P.S. Here are 6 goals you can set to help you improve audit management.)
Training compliance is a common target for audits. Auditors want clear proof that your team is trained on the right procedures at the right time. A training module that includes built-in dashboards and reporting capabilities makes it easy to show exactly that. Make sure the Training Module in your eQMS allows you to:
Example: Need to show everyone at a specific site was trained on a new SOP? A filtered dashboard should get you there instantly.
Auditors often follow the trail from a deviation to a CAPA to related SOP updates and retraining. Your system should link all those elements automatically so you can show a complete response path. Your Issues Management software should have features that allow you to:
Example: If asked how a recurring issue was addressed, you can show the full lifecycle – from root cause to resolution – all within one workflow.
Keeping tabs on internal and external audits is easier when your system has a dedicated audit module. Look for one that helps you track audit dates, related vendors, and outstanding actions all in one place. These features should allow you to:
By tracking recurring audits in the system, you can show patterns of improvement over time. Additionally, it reduces the need to recreate audit plans for each vendor.
Audit trails are essential for proving compliance, but manually tracking who did what, when, and why is risky and time-consuming. An audit-ready eQMS should generate those records automatically, making it possible to:
Auditors expect traceability. Your eQMS audit trail helps you meet that expectation without extra prep. That way, if asked who approved a change or when a document was updated, your audit trail will already have the answer.
Even the best QMS software can’t speak for your team. Your people need to understand how to use it and how to talk through their processes with confidence.
Assigning someone to guide the auditor through the system, retrieve records, and keep the conversation on track is an important part of audit best practices. Review roles ahead of time: Who’s answering the questions? Who’s providing backup? Who owns follow-up?
It can even be helpful to train your team to think like an auditor. Whether through internal workshops or formal certifications, understanding what auditors typically look for can help staff respond under pressure.
Clear, confident answers are a hallmark of strong quality audit preparation.
Audit success isn’t about scrambling to get everything right at the last minute. It’s about building quality habits that hold up year-round. A well-run eQMS helps make audit prep a natural extension of your daily operations.
And while passing the audit matters, the best quality teams use inspections as fuel for continuous improvement. Log findings, close quality gaps, and revisit audit goals regularly – not just for compliance, but to strengthen your overall quality program.
At the end of the day, even the most audit-ready organizations aren’t perfect – but they’re consistent, transparent, and continuously improving.
Watch our 3-minute demo or download our eQMS 201 eBook to learn how we help quality teams improve document control, track training, and manage CAPAs all in one place.