SQA Cheat Sheet 2026

The 30 highest-yield SQA facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. Under GLP, how should multiple samples from the same animal or subject be differentiated in raw data? → By unique individual identification such as animal number, sample code, or collection time
2. Which professional designation is offered by SQA to recognize demonstrated competency in quality assurance? → Registered Quality Assurance Professional (RQAP-GLP)
3. What trait does a test for quality assurance look for in applicants? → Proficiency in key areas important for a Quality Assurance specialist
4. In a GLP nonclinical study, which document is used to formally transfer responsibility from the sponsor to the test facility? → Study protocol signed by both sponsor and Study Director
5. How must superseded (outdated) SOPs be handled under GLP? → Retained in archives with the date of supersession noted
6. Which regulatory pathway allows a sponsor to request FDA agreement on the acceptability of a nonclinical testing program before studies are conducted? → Pre-IND meeting with FDA to discuss the nonclinical development plan
7. Which method validation parameter measures how close test results are to the true value? → Accuracy
8. What factors in a Quality Assurance test increase a candidate's likelihood of being invited to the following stages of the recruiting process? → Performing well in the test (typically in the top 50%)
9. Under US GLP regulations, which agency has GLP oversight authority for pesticide studies submitted under FIFRA? → U.S. Environmental Protection Agency (EPA)
10. Which audit technique involves direct observation of study personnel performing their tasks? → Witnessing
11. Under GLP, which facility personnel must be sufficiently trained and qualified to perform their assigned functions? → All personnel involved in the conduct of the study
12. How does a Quality Assurance test assist in evaluating a candidate's qualifications? → The candidate's technical abilities
13. Which of the following scenarios constitutes a data integrity violation in a GLP study? → Pre-dating a laboratory notebook entry to match when the experiment was originally planned
14. Which FDA guidance document provides the agency's current thinking on GLP regulations for nonclinical laboratory studies? → FDA's Bioresearch Monitoring compliance program guidance manuals for GLP inspections
15. What does a sample report look like that comes out of a quality assurance test? → Results for the Quality Assurance Test along with other assessments in a candidate report
16. Which concept requires that pharmaceutical manufacturing processes consistently reproduce output meeting predetermined specifications? → Process Validation
17. What are the three stages of FDA's current process validation lifecycle framework (2011 Guidance)? → Process Design, Process Qualification, and Continued Process Verification
18. What is required when computerized systems are used to collect GLP raw data? → Validation of the system, access controls, audit trails, and backup procedures
19. When a QA inspector discovers that a study was conducted without a signed, approved protocol, what classification of GLP issue does this represent? → A critical GLP nonconformance because the protocol is required before study initiation
20. Which skill is most critical for a QA inspector when reviewing laboratory raw data for GLP compliance? → Attention to detail and the ability to identify missing, altered, or inconsistent entries
21. Which activity must occur before an auditor can close a previously identified nonconformance? → Verification that the corrective action has been effectively implemented
22. What is the primary purpose of a GLP facility inspection conducted by the QAU? → To verify that facilities, equipment, personnel, and methods comply with GLP regulations
23. Non-functional testing can take the following forms, with the exception of: → None of these
24. What kinds of questions are on a test for quality assurance? → Multiple-choice questions
25. Which document defines step-by-step instructions for performing a laboratory test method? → Standard Operating Procedure (SOP)
26. Which regulation governs Good Laboratory Practice (GLP) compliance in non-clinical safety studies in the US? → 21 CFR Part 58
27. The second stage of developing a test scenario is where it is. → Evaluating users with a hacker's mindset.
28. the method of testing used to ensure sure the system can manage unforeseen circumstances. → Negative Testing
29. Under GLP, the QAU must maintain a record of all inspections performed. What must this record include? → Date of inspection, study inspected, phase of study inspected, and name of inspector
30. What is a Quality Assurance test's main goal? → To ensure candidates have the necessary skills for a Quality Assurance role