Audit Survival Kit: Vocabulary, Phrases, and Strategies for Stress-Free Compliance
Hanna Hredil- Apr 27
- 8 min read
Updated: Apr 28
Audits can be intense.
Whether you're preparing for a GMP, GCP, GLP, or ISO audit, one thing is clear: your communication must be precise, professional, and calm.
Choosing the right words can make a huge difference.
Today, let's walk through key vocabulary and expressions that pharma and life science professionals use during audits.
If English is not your first language, mastering these terms will help you handle audits with more confidence and credibility.
Essential Vocabulary for Audits
1. Compliance
Definition: Meeting regulatory and internal standards.
Example: “We are in full compliance with all applicable guidelines.”
2. Nonconformity
Definition: A deviation from a requirement.
Example: “We identified a nonconformity during the internal audit and implemented corrective actions.”
3. Corrective Action
Definition: Steps taken to eliminate the cause of a detected nonconformity.
Example: “Corrective actions have been completed, and we have updated our SOPs accordingly.”
4. Preventive Action
Definition: Steps to eliminate the cause of a potential nonconformity.
Example: “We introduced preventive measures to minimize future risks.”
5. Observation
Definition: A potential issue noted by the auditor that is not yet a violation.
Example: “The auditor made an observation about our document storage practices.”
6. Deviation
Definition: Departure from an approved procedure or standard.
Example: “We documented the deviation and initiated an investigation.”
7. Finding
Definition: A conclusion based on audit evidence.
Example: “The audit finding highlighted the need for additional training.”
8. Root Cause
Definition: The underlying reason for a problem.
Example: “We conducted a root cause analysis to understand the issue fully.”
9. Documentation
Definition: Records and evidence supporting compliance.
Example: “All documentation is available for auditor review.”
10. SOP (Standard Operating Procedure)
Definition: Detailed, written instructions to achieve uniformity in performance.
Example: “We followed the SOP for sample handling.”
11. Protocol Deviation
Definition: A departure from the study protocol in clinical trials.
Example: “We recorded the protocol deviation and reported it as per requirements.”
12. CAPA (Corrective and Preventive Action)
Definition: A systematic approach to identifying and eliminating causes of problems.
Example: “Our CAPA system ensures continuous improvement.”
13. Risk Assessment
Definition: The process of identifying and evaluating risks.
Example: “We completed a risk assessment before the project launch.”
14. Audit Trail
Definition: A record showing who accessed a system and what operations were performed.
Example: “The audit trail confirms data integrity.”
15. Data Integrity
Definition: Maintaining the accuracy and consistency of data over its lifecycle.
Example: “We ensure data integrity through regular system checks and audits.”
16. Inspection Readiness
Definition: Being fully prepared for an audit or regulatory inspection at any time.
Example: “Inspection readiness is part of our continuous improvement strategy.”
17. Deficiency
Definition: A failure to meet a requirement.
Example: “The deficiency was corrected within the specified timeframe.”
18. Regulatory Requirement
Definition: Standards and rules set by authorities such as the FDA, EMA, or MHRA.
Example: “We operate according to all current regulatory requirements.”
19. Traceability
Definition: The ability to track the history, location, or use of an item.
Example: “We maintain full traceability of all raw materials and finished products.”
20. Good Documentation Practices (GDP)
Definition: Standards for recording and maintaining data properly.
Example: “GDP compliance is essential for maintaining data credibility and reliability.”
Useful Phrases for Communicating During Audits
When welcoming the auditor:
"Welcome. We are ready to begin. Please let us know if there is anything specific you would like to review first."
"We appreciate your visit and have prepared a comfortable space for document review. Our team is fully available to assist you throughout the audit."
"Thank you for coming today. Our team is available to support the audit process and answer any questions you may have."
"We have prepared all documentation for your review and can retrieve additional records as needed if you require them."
"Please let us know if you require any assistance at any time during your visit. We aim to make the process as smooth as possible."
When describing processes:
"This procedure is outlined in our SOP 003, which details each step for sample preparation, from collection to storage."
"The process is documented here in the equipment maintenance log for your verification. All preventive maintenance was completed on schedule."
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