IndustriesGLP laboratories
GLP quality management software with Study Director sign-off
A GLP facility needs the Study Director in control of every study, a QAU that stays independent, and a record of every deviation in the final report. QMSdesk™ GLP quality management software builds all three into the workflow, so your studies hold up when the QAU, management or an inspector looks back.
Usual profiles for this work
Regulations they carry
ISO 9001; ISO 31000:2018; 21 CFR Part 11; ALCOA+ data-integrity principles; 21 CFR Part 58; OECD GLP Principles; EU GLP Directive 2004/10/EC
- Retention floor
- 10 years
- Event workflows
- 12, including Test item nonconformance and Unscheduled observation
- Key deadline
- Study Director sign-off on study deviations within 1 calendar day
A typical starting set. You choose your own profiles, and can add more at any time.
What GLP quality management software changes for you
01
The Study Director sees it first
Every study deviation goes to the Study Director for a signed review within a day, before the QAU is notified or the investigation begins.
02
The final report is never missing a deviation
The final-report note is a signed step every study deviation passes through. There's no path to closure without it.
03
Your QAU stays independent
Management is notified of every QAU finding as its own step, within 7 days, whoever else has already seen it.
What the rules ask of you, and how QMSdesk supports it
GLP rules protect the integrity of nonclinical safety studies. They come down to three things: the Study Director is in charge of each study, the Quality Assurance Unit checks independently, and every deviation is recorded in the final report. QMSdesk builds all three into the workflow, so a study deviation can't close without them.
| Regulation | What it asks of you | How QMSdesk supports it |
|---|---|---|
| 21 CFR Part 58 | FDA's Good Laboratory Practice for nonclinical laboratory studies. | Every study deviation goes to the Study Director for a signed review within 1 day. Management is notified of every QAU finding within 7 days, as §58.35(b)(4) requires. |
| OECD Principles of GLP (1997) | The international GLP standard. | The final-report note is a mandatory signed step for every study deviation. |
| EU GLP Directive 2004/10/EC | The EU framework that applies the OECD Principles. | Carried by the same GLP profile, with 10-year minimum retention. |
| 21 CFR Part 11 | Electronic records and signatures you can trust as much as paper. | Electronic signatures and a hash-chained audit trail for every customer. |
The GLP profile, step by step
A GLP test facility holds BASE and GLP.
A study deviation workflow in 6 steps
Step 1 of 6
Reported
With the study number and study phase.
Step 2 of 6
Signed stepStudy Director review
Within 1 day: the decision, the impact on study integrity and whether the protocol needs amending.
Step 3 of 6
QAU notification
Within 1 day of that review.
Step 4 of 6
Investigation
With the root cause and the correction applied.
Step 5 of 6
Signed stepFinal-report note
The note's text and the report section it goes in. The step is mandatory, following OECD GLP's rule that every deviation is noted in the final study report.
Step 6 of 6
Signed stepClosed
A QAU finding workflow in 5 steps
Step 1 of 5
Signed stepRaised
Naming the study or facility and the QAU inspector.
Step 2 of 5
Signed stepManagement notification
Within 7 days, as 21 CFR 58.35(b)(4) requires. It's tracked on its own, even when the Study Director has already reviewed the finding.
Step 3 of 5
Response
Root cause, corrective action and preventive action, due in 30 days.
Step 4 of 5
Signed stepQAU verification
Due in 90 days. An insufficient response goes back for another.
Step 5 of 5
Signed stepClosed
Everything else a GLP facility records
Equipment calibration failures, test-item nonconformances and unscheduled observations each have their own event type, on the deviation, nonconformance and incident workflows.
Roles: Study Director and Quality Assurance Unit (QAU), alongside the nine standard roles every organization gets. Retention floor in QMSdesk: 10 years, applied to every record in your organization's QMSdesk.
A missed deadline escalates the record through a reminder ladder, and it never blocks the work.
The modules that matter most
Quality events
Study deviations and QAU findings run beside your other events, each on its own locked path. Records raised in error are cancelled with a signed reason and never deleted.
Audit management
Plan the inspection program on a calendar, with templates. Auditors can't audit their own department, and every open finding sits in one register.
CAPA
A CAPA can start from a finding, a trend or a management review. An effectiveness check follows closure, and a failed check raises a new linked CAPA.
Training and competency
Training is assigned when an SOP is approved, a role changes or someone joins. It's completed by signed acknowledgment, quiz, practical assessment or external certificate.
Document control
SOPs are signed at authoring, review and approval by three different people, with training assigned on approval.
Audit trail and e-signatures
Every entry is SHA-256 hash-chained, and the database keeps the log insert-only.
Every tier includes every module: document control, quality events, CAPA, change control, training, risk, audits, supplier quality, management review and reporting. See the whole platform
Questions buyers ask
Can a study deviation close without a final-report note?
No. The final-report note is a signed step on the way to closure, and there's no route that skips it.
How does QMSdesk keep the QAU independent of the Study Director?
Management notification is its own signed step on every QAU finding, due within 7 days, whatever the Study Director has already done. The QAU verifies the response and signs it off.
What happens when a deadline is missed?
The record escalates through a reminder ladder, from the owner to the coordinator to the Quality Manager. It's never blocked, and a late step records the reason for the delay.
Can we run GLP alongside GMP or ISO 17025?
Yes. Profiles combine, and the strictest rule applies: the union of event types and roles, the shortest deadline and the longest minimum retention period. A CDMO running nonclinical GLP studies holds BASE, GMP, Contract operations and GLP. See testing laboratories.
How is QMSdesk priced?
By organization tier, never per seat, and every tier includes every module. See pricing.
Build your regulatory profile
Tell us about your studies. We'll show you QMSdesk working under GLP.
Early-stage and growth teams can apply for the 2026 Early Adopter Program.