AuditsCompliance-in-a-Box: The Startup Guide to Audit-Ready DocsSVSid Varma · 12 min readFor testing facility management, study directors and QAU leads running nonclinical safety studies for FDA submissions. What Part 58 requires in writing, and what FDA investigators request.
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Checked against primary sources on 18 October 2026.
Testing facilities, including contract laboratories and consultants, that conduct nonclinical laboratory studies supporting FDA research or marketing applications for drugs, biologics, devices, food and color additives.
FDA Bioresearch Monitoring (BIMO) investigators under Compliance Program 7348.808
FDA aims to inspect laboratories conducting safety studies approximately every two years, plus directed inspections tied to specific studies; inspections of commercial laboratories are conducted without prior notification
21 CFR Part 58, current eCFR text (up to date as of 2026-10-15), 2002-05-21. Free to read.
| Date | What happens | Status |
|---|---|---|
| 2026-10-06 | Revised FDA Compliance Program 7348.808 for GLP inspections takes effect | Done |
Each one needs an owner, an approval, and proof it reached the people it covers.
21 CFR 58.81
Written SOPs cover study methods, at least the areas listed in 58.81(b), with significant changes authorized in writing by management and a dated historical file kept.
21 CFR 58.29(b)
The testing facility keeps a current summary of training and experience and a job description for each person conducting or supervising a nonclinical study.
21 CFR 58.35
QAU responsibilities, procedures, records and indexing method are in writing, with a master schedule of studies and signed records of each periodic inspection.
21 CFR 58.120
Each study has an approved written protocol, dated by the sponsor and signed by the study director, with every change documented, signed, dated and kept with it.
21 CFR 58.190 and 58.195
Raw data, protocols, reports and specimens go to indexed archives under a named custodian, retained for the shortest applicable period set out in 58.195.
Citations are to the standard or regulation; wording is ours.
What reviewers sample about these documents and the people they cover.
Investigators review the SOP index and representative SOPs against 58.81(b), confirm only current SOPs are at workstations, and check authorization signatures, dates, the historical file and periodic review.
Investigators check that procedures exist for familiarizing employees with SOPs, and observe staff performing selected operations to judge adherence.
For selected employees, investigators check that training summaries and position descriptions are current and that staff, including on-site contractors, are trained in GLP.
Investigators obtain the master schedule for the last two years or since the last inspection, review QAU SOPs and inspection records, and may ask management to certify QAU inspections in writing.
Write each policy, send it through approval, and send it to the people it covers. Each acknowledgment is recorded by name, with the version, the date and the time.
When a policy changes, the new version is approved, its Editor sends it out again, and everyone it applies to is asked again. Export the record as a PDF or CSV, or give a reviewer Viewer access to the documents their tags allow.
Need help with the rest of FDA GLP (21 CFR Part 58)? Find a consultant for your standard (opens in a new tab).
Your region’s laws, the standards your customers ask for, and your own house rules. Write each one as a policy, approve it, and send it to the people it covers.
Section 58.81(a) requires deviations from SOPs during a study to be authorized by the study director and documented in the raw data. Significant changes to established SOPs must be authorized in writing by management.
Section 58.195(b) sets the shortest of three periods: two years after FDA approves the application the study supported, five years after the results are submitted, or two years after study completion when results are not submitted. Other regulations may require longer.
Section 58.15(a) excludes QAU records of findings, problems and actions taken from FDA's records inspection and copying. The QAU's written procedures and the dates, studies, phases and inspector names of its inspections must still be available to FDA.
FDA proposed a GLP quality system approach on 24 August 2016, and the eCFR text has not changed since 2002. The Fall 2025 Unified Agenda lists the rulemaking at the proposed rule stage with an NPRM timetable of August 2026.
Compliance Program 7348.808 carries an implementation date of 6 October 2026. It sets a surveillance aim of roughly every two years and lists the management, personnel, QAU, SOP and archive checks investigators make.
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