Auditing approaches for routine studies vs. unique or custom studies

SQA 2025 -- The goal of assuring the integrity of data never changes, when conducting audits. Multiple approaches may be utilized based on the type of study conducted. Compendial methods that a lab conducts routinely have different risks than a complex, one-time study. Understanding the similarities and differences in approaches can assure compliance during protocol review, in-process audits, data audits and final report audits.