21 CFR Part 58 · Good Laboratory Practice · Evidence & Implementation Kit
Run GLP-compliant nonclinical studies, without turning 21 CFR Part 58 into a quality system yourself.
Every GLP requirement handed to you as an adopt-ready control, from the study director and the independent Quality Assurance Unit through SOPs, test article characterization and the archive, with the evidence an FDA inspector examines.
Inspection-ready in a weekend, not a quarter.
Here is the honest situation. If your nonclinical safety studies support an FDA submission, they must follow 21 CFR Part 58 Good Laboratory Practice, and the FDA inspects for it. GLP runs on specific roles and records: the study director as the single point of control, an independent Quality Assurance Unit, SOPs for everything, test article characterization, and a controlled archive with the study director's signed report and the QAU statement. Building that quality system and its evidence, and surviving an FDA inspection, is months of work, and a weak QAU or an uncharacterized test article is exactly what an inspector writes up.
This Kit removes that build. It is every GLP requirement written as an adopt-ready control you personalize in a weekend, with the evidence an FDA inspector examines.
What you get, the moment you buy
32
Requirements as adopt-ready controls. Every 21 CFR Part 58 requirement, from organization and personnel and the QAU through facilities, SOPs, test articles, study conduct and records retention, written so you personalize and apply it.
32
Evidence-they-examine checklists. For each requirement, exactly what an FDA inspector examines, plus where GLP inspections find problems, so you close it before the inspection.
1
GLP Control Matrix, pre-built. Every requirement in a working spreadsheet, ready to record status and evidence location across the testing facility.
1
Gap & Readiness Assessment. Score each requirement and the workbook returns your inspection readiness as a single percentage, and exactly what to fix next.
Grounded in 21 CFR Part 58, with the study director, the independent Quality Assurance Unit, SOPs, test article characterization and the archive called out. Editable Word and Excel files.
The QAU and the study director are the backbone
GLP holds together on two roles: the study director as the single point of study control, and an independent Quality Assurance Unit that inspects and signs off. This Kit builds both, with the master schedule, inspection records and the QAU statement, so the structure an FDA inspector checks first is in place.
What one control looks like
This is the independent Quality Assurance Unit, the role an FDA inspector examines first. All 32 are built to this depth.
58.35 Quality assurance unit independence QUALITY ASSURANCE
Meet this requirement
[Testing Facility] shall establish a quality assurance unit staffed by individuals who are entirely separate from and independent of the personnel directing and conducting each study, and this unit shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls conform to the regulations in this part.
Compliance note.
The independence requirement is foundational; a quality assurance reviewer must not inspect a study in which they participated as study personnel.
Evidence an FDA inspector examines
- Quality assurance unit charter and reporting line separate from study operations
- Roster showing quality assurance staff are not assigned to studies they inspect
- Signed independence attestations for quality assurance personnel
- Quality assurance unit standard operating procedures
Common finding they raise: Quality assurance duties are assigned to staff who also perform study tasks, compromising the required independence of the monitoring function.
Why this is not another template pack
- The evidence is the point. A study you cannot evidence fails inspection. This tells you exactly what an FDA inspector examines and where inspections find problems, for every requirement.
- The GLP roles built in. The study director as single point of control and the independent QAU are written into the controls, the roles that define GLP.
- Built on a mapped compliance corpus, not one person's opinion, from a graph of thousands of controls across standards.
- It compounds. GLP shares data-integrity and records discipline with GMP and GCP, so this work feeds your wider quality system.
Who buys this
Nonclinical testing facilities running FDA-regulated safety studies, the study directors, QA units and quality leads who own GLP, and consultants preparing a facility for inspection. Whether it is a first study or an FDA inspection, you save weeks and walk in with the controls and evidence ready.
By the end of the weekend you will have
✓ An adopt-ready control for all 32 requirements
✓ A completed GLP control matrix
✓ The evidence an FDA inspector examines
✓ Your study director and QAU roles defined
✓ An inspection-readiness percentage and a fix list
✓ The common inspection findings closed
Common questions
Is it really editable? Yes. Word and Excel files you own and adapt. No portal, no subscription.
Is this legal advice? No. It is an implementation toolkit grounded in 21 CFR Part 58. For a specific submission consult your regulatory function; this gets your quality system and records in order fast.
Does it cover the QAU? Yes. The independent Quality Assurance Unit, with its master schedule, inspections and signed statement, is its own control group.
Does it cover records retention? Yes. The archive, records retrieval and retention periods are their own controls, because a broken archive is a common finding.
What if it is not for me? A 30-day money-back guarantee.
Do not turn a federal regulation into a quality system by hand.
Every GLP requirement is fast to adopt with the Kit. It is instant, and it is guaranteed.
Add it to your cart and be inspection-ready this weekend.
Instant digital download · 30-day money-back guarantee · The Art of Service Pty Ltd, GPO Box 2673, Brisbane QLD 4001 · support@theartofservice.com
