QMS software by industry, configured from your regulations
A GLP lab, a device maker and a CDMO answer to different rules. QMSdesk™ is built from those rules. You hold the regulatory profiles for the regulations you work under, and they set the event types, roles, deadlines and retention floor those regulations require.
What changes when your QMS knows your regulations
01
You start aligned
Your first workflows already carry the event types, roles and deadlines your regulations call for.
02
You grow without starting over
Add a device line, a GLP lab or a manufacturing site, and its obligations arrive in the system you already run.
03
Your strictest rule always wins
Hold several profiles, and the tightest deadline and the longest retention floor apply.
From your industry to your regulations
Regulatory profiles are the rules. QMSdesk has twelve, built from a registry of 27 regulations, standards and guidelines. Each one turns on the event types, roles, deadlines and minimum retention period its regulations call for. Every organization holds BASE, the universal baseline.
Your industry tells you which regulations usually apply. Each page below lists them, and the profiles that carry them. When you set up QMSdesk, you choose your profiles directly, several at once, and see every regulation they carry before you commit.
Profiles can be added at any time, including after go-live, and never removed. Records created under a profile keep its rules for as long as they're retained.
Life sciences QMS software by industry
Pharmaceutical
BASE + GMP
Batch deviations contained within a day, two-phase OOS investigations, the QP role and a 10-year minimum retention period.
Medical devices
BASE + MDR, plus IVDR for diagnostics
Vigilance on the complaint workflow, UDI and serial numbers on nonconformances, the PRRC role, and retention for the device lifetime plus 15 years.
Biotechnology
BASE + GCP + GMP + ATMP
Protocol and batch deviations in one system. Start clinical-stage with GCP, and add manufacturing when you're ready.
CRO
BASE + GCP + Contract operations
Protocol and quality-agreement deviations, sponsor-facing roles and a 15-year retention floor.
CDMO
BASE + GMP + Contract operations
Batch deviations, quality-agreement deviations and tech-transfer issues, side by side under GMP.
Testing laboratories
BASE + ISO 17025, plus Contract operations for client work
Laboratory Director, Technical Manager and Metrology Specialist roles. OOS/OOT and CAPA come from the base platform.
GLP laboratories
BASE + GLP
A study-deviation workflow with Study Director sign-off within 1 day, and QAU findings with management notified within 7 days.
Cell and gene therapy
BASE + GMP + ATMP
Process nonconformances covering cell line, batch and critical quality attribute, and the longest retention floor: 30 years.
Compounding pharmacy
503A or 503B
A 503A pharmacy gets medication-dispensing nonconformances and the Chief Pharmacist role. A 503B outsourcing facility holds GMP, with a 10-year floor.
Healthcare providers
BASE + Healthcare
Patient safety events contained in 5 days and investigated in 45, always with a CAPA. HIPAA breach, adverse drug event and near-miss events.
What every industry gets
Every tier includes every module: document control, quality events, CAPA, change control, training, risk, audits, supplier quality and management review. Every audit-trail entry is SHA-256 hash-chained to the one before it, and signatures record what they mean.
You configure and test in your real tenant through a guided runway, and go-live takes two separately signed attestations. The target for a first working workflow is 8–12 weeks, depending on scope, data readiness and your team's availability. See how implementation works.
Build your regulatory profile
Select what your organization does. See the profiles you'd hold, your retention floor, your key deadlines, your roles and your workflows, straight from the product's registry.
Questions buyers ask
Which regulatory profiles does my organization need?
Start with the regulations you answer to. Your industry page lists the usual ones, the profile builder shows the profiles that carry them, and we'll confirm the set with you before you commit.
We work across more than one sector. Is that a problem?
No. Hold several profiles, and QMSdesk combines them. A CDMO that runs nonclinical GLP studies holds GMP, Contract operations and GLP, with the strictest rule applied wherever two differ.
Can we add a profile later?
Yes, at any time, including after go-live, under e-signature and change control. A profile, once added, stays, so the rules your records were created under always stand.
What if our sector isn't listed?
Choose profiles directly, or start from BASE: the core event and CAPA workflows, Part 11 electronic signatures, ALCOA+ and a 7-year retention floor.
Tell us what you do. We'll show you QMSdesk working under your regulations.
Bring one real workflow from your sector, and we'll walk it through QMSdesk with you. Early-stage and growth teams can also join the 2026 Early Adopter Program.