PlatformRegulatory profiles
A multi-regulation QMS, built from the regulations up
Choose the regulatory profiles for the regulations you work under, and QMSdesk™ runs on their rules. Twelve regulatory profiles combine in one multi-regulation QMS, and where two rules differ, the stricter one applies.
Profiles held
A profile can be added at any time, and never removed.
What a multi-regulation QMS changes for you
01
Start aligned
Your event types, roles, deadlines and retention come from the regulations you hold.
02
Grow without starting over
Add a device line or a GLP lab, and its obligations arrive with it.
03
Never weaker than your strictest rule
The strictest obligation you hold always applies.
GMP and GLP in one QMS: how profiles combine
With several profiles, fixed rules apply:
Event types, roles, master data and required fields
The union.
Retention floor
The longest, whether 7, 10, 15 or 30 years.
Step deadlines
The shortest.
Electronic signature
Required if any profile requires it.
Terminology
A profile's renamed objects apply only when no other held profile renames them differently.
A CDMO that also runs nonclinical GLP studies holds BASE, GMP, Contract operations and GLP. Batch deviations and study deviations run side by side, and the retention floor is 10 years.
Added, never removed
- Add a profile at any point, including after go-live, under e-signature and change control.
- No one can remove one, including the platform operator.
- Existing records keep the rules they were created under, and retention clocks can only lengthen.
- Before you commit, onboarding shows every profile you'll hold and every regulation it carries.
The twelve regulatory profiles
| Profile | Regulations | What it turns on |
|---|---|---|
| BASE (every tenant) | ISO 9001, ISO 31000, 21 CFR Part 11, ALCOA+ | The core event and CAPA workflows. 7-year floor. E-signature at approval and closing steps. |
| GMP | 21 CFR 210/211, EU GMP incl. Annex 11, ICH Q10, ICH Q7, WHO GMP | Batch deviation (1-day containment), environmental excursion and product recall. OOS Phase 1 within 1 business day. 10-year floor. QP, QC Head and Batch Release Specialist roles. |
| MDR | ISO 13485, FDA QMSR (21 CFR 820), EU MDR, ISO 14971 | MDR vigilance on complaints and post-market surveillance events. UDI and serial number on nonconformances. US MDR 30-day and EU serious-incident 15-day deadlines. Retention for the device lifetime plus 15 years, with 15 years as the enforced minimum. PRRC role. |
| IVDR | EU IVDR, ISO 13485 | States your IVD position, with no event types or roles of its own. Retention as MDR. |
| GCP | ICH E6, 21 CFR 312, ICH Q10 | Protocol deviation. 15-year floor. Principal Investigator, CRA and Medical Monitor roles. |
| GLP | 21 CFR Part 58, OECD GLP, EU GLP | A 6-step study-deviation workflow with Study Director sign-off within 1 day. A 5-step QAU finding workflow with management notified within 7 days. 10-year floor. |
| ISO 17025 | ISO/IEC 17025 | Laboratory Director, Technical Manager and Metrology Specialist roles. 7-year floor. |
| Contract operations | ICH Q10 §2.7 | Held alongside your governing profile. QA-agreement deviation and tech-transfer issue events. Sponsor QM and Quality Agreement Owner roles. |
| Healthcare | HIPAA, The Joint Commission, EN 15224 | Patient safety event workflow: containment in 5 days, investigation in 45, and a CAPA always raised. HIPAA breach, adverse drug event and near-miss events. 10-year floor. |
| Pharmacy 503A | State boards of pharmacy, USP <795>, <797>, <800> | Medication-dispensing nonconformance. Chief Pharmacist role. 7-year floor. |
| Pharmacy 503B | 21 CFR 210/211, USP <797>, <800> | Held with GMP, for outsourcing facilities. 10-year floor. |
| ATMP | EudraLex Vol. 4 Part IV | ATMP process nonconformance covering cell line, batch and critical quality attribute. 30-year floor, the longest. Held alongside GMP. |
Thin profiles are deliberate: they let you state your regulatory position accurately. The Healthcare profile sets up the workflows these regimes call for; it configures your system rather than certifying it.
Looking for a standard GxP setup? That's BASE. Every tenant holds it: the core event and CAPA workflows, Part 11 electronic signatures, ALCOA+ and a 7-year floor.
Build your regulatory profile
Select what you do and see your profiles, retention floor, deadlines, roles and workflows, straight from the product's registry.
Feature index
Everything in regulatory profiles
- 12 regulatory profiles, built from a registry of 27 regulations, standards and guidelines
- Profiles chosen directly at onboarding, several at once
- The resolved profile set shown before you commit
- Strictest-wins resolution: union of requirements, longest retention (7, 10, 15 or 30 years), shortest deadline, e-signature if any profile needs it
- Profile workflows: GLP study deviation, GLP QAU finding, patient safety event
- Profile event types, from batch deviation and MDR vigilance to HIPAA breach and ATMP process nonconformance
- Profile roles, including QP, PRRC, Study Director, Laboratory Director, Sponsor QM and Chief Pharmacist
- Add-only for the life of your tenant, under e-signature and change control
One connected system
Connected across QMSdesk
Which profiles does your sector hold? See pharmaceutical, medical devices, CDMO, GLP laboratories, cell and gene therapy and compounding pharmacy.
Implementation: choose your profiles when you set up your tenant, and add more after go-live.
Risk management: every organization scores on the same 5×5 matrix.
Regulations
Regulations it's designed to support
Each profile shows exactly the regulations in its bundle. Start with 21 CFR Part 11, FDA QMSR, EU GMP Annex 11 and ICH Q10. The MDR and IVDR profiles are built to support organizations working to ISO 13485:2016.
Questions buyers ask
Can we run GMP and GLP in one QMS?
Yes. Hold both profiles and QMSdesk combines them: batch and study deviations in one system, with the strictest rules applied.
Can we remove a profile if we stop an activity?
No. Records created under a profile keep its rules for as long as they're retained, so a profile, once added, stays.