IndustriesCompounding pharmacy
503A and 503B quality management software for compounding pharmacies
A compounder needs sterile and hazardous-drug work under control, every dispensing error investigated, and records an inspector or a state board can follow. QMSdesk™ is 503B quality management software that holds your outsourcing facility to GMP, and a compounding pharmacy quality system for 503A that brings patient safety into the same place.
Usual profiles for this work
Regulations they carry
ISO 9001; ISO 31000:2018; 21 CFR Part 11; ALCOA+ data-integrity principles; 21 CFR Parts 210/211; EU GMP (EudraLex Vol. 4), including Annex 11; ICH Q10; ICH Q7; WHO GMP (Technical Report Series); USP <795>, <797>, <800>
- Retention floor
- 10 years
- Event workflows
- 10, including Environmental excursion and Product recall
- Key deadline
- Batch deviation containment within 1 calendar day
A typical starting set. You choose your own profiles, and can add more at any time.
What changes for your pharmacy
01
Excursions handled the same way every time
An environmental excursion or a batch deviation starts its own defined workflow. A batch deviation's containment is due within a day.
02
Errors that lead somewhere
A dispensing discrepancy gets a signed disposition. When it needs a CAPA, the signed decision raises one.
03
Staff you know are trained
Approve a compounding SOP and the training is assigned. Practical assessments are signed by a qualified assessor.
What the rules ask of you, and how QMSdesk supports it
Compounding rules come from USP and your state board of pharmacy, and from FDA's GMP rules if you're a 503B outsourcing facility. They ask for sterile and hazardous-drug work under control, trained staff and every error investigated. QMSdesk turns each of these into a signed workflow, so an inspector or a state board can follow the record from event to fix.
| Regulation | What it asks of you | How QMSdesk supports it |
|---|---|---|
| USP <795>, <797> and <800> | Nonsterile compounding, sterile compounding and hazardous drugs. | Approving a compounding SOP assigns the training, and practical assessments are signed by a qualified assessor. |
| Your state board of pharmacy | Licensing and inspection of your pharmacy. | Records a board can follow, and a Chief Pharmacist role. |
| 21 CFR Parts 210 and 211, for 503B | Manufacturing rules for outsourcing facilities. | Batch deviations contained within 1 day, environmental excursions, OOS investigations and 10-year minimum retention. |
| Patient safety, for 503A | Pharmacies that serve patients directly. | Patient safety events with containment in 5 days, investigation in 45 and a CAPA raised every time, plus medication-dispensing nonconformances. |
| 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. |
Every customer also holds BASE, the quality baseline, which carries 21 CFR Part 11, ALCOA+, ISO 9001 and ISO 31000. The profiles set up your workflows; they don't certify your pharmacy.
503B quality management software, held with GMP
A 503B outsourcing facility is regulated as a manufacturer. So in QMSdesk, the 503B profile is held with GMP, not with the Healthcare profile. An outsourcing facility holds BASE, GMP and Pharmacy 503B.
GMP brings:
- batch deviations, with containment due within 1 day;
- environmental excursions and product recalls;
- OOS investigations with a Phase 1 deadline of one business day;
- QC Head and Batch Release Specialist roles, among others.
Pharmacy 503B adds USP <797> and <800> to your regulations and a Chief Pharmacist role. It has no event types of its own, because GMP's already cover the work. Retention floor in QMSdesk: 10 years.
A compounding pharmacy quality system for 503A
The 503A profile adds the medication-dispensing nonconformance, which runs on the nonconformance workflow with a signed disposition, and a Chief Pharmacist role. Its own minimum retention period is 7 years.
A 503A pharmacy also holds the Healthcare profile, because it serves patients directly. That brings a patient safety event workflow, with containment due in 5 days, investigation in 45, and a CAPA raised every time. It also brings adverse drug event and near-miss event types. With Healthcare held, the strictest rule sets your minimum retention period at 10 years. You can also choose the 503A profile on its own.
The modules that matter most
Deviations and nonconformances
Major and critical deviations require containment, investigation and a signed CAPA decision. A nonconformance's "use as is" needs a technical rationale.
OOS/OOT investigations
A Phase 1 lab investigation and a signed review come before anything else. Lab-error invalidations are trended by method, analyst and instrument.
CAPA
The approved action plan raises the change control and training the fix needs. An effectiveness check follows closure, and a failed check raises a new linked CAPA.
Document control
SOPs are signed at authoring, review and approval by three different people. USP chapters and other external standards are held as reference documents, readable in the app with download switched off where the license requires it.
Training and competency
Four ways to complete training, recurring refreshers, and competency assessments by qualified assessors.
Supplier quality
Suppliers are qualified by risk tier, with certificate alerts at 90, 60 and 30 days, and an expired certificate opens a risk.
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
We're a 503B outsourcing facility. Why do we hold the GMP profile?
Because a 503B facility is an FDA-inspected manufacturer. You get GMP's batch deviations, environmental excursions, recalls, OOS deadlines and 10-year minimum retention, plus the 503B profile's USP chapters and Chief Pharmacist role.
Does a 503A pharmacy get patient safety workflows?
Yes. A 503A pharmacy holds the Healthcare profile too, so patient safety events, adverse drug events and near misses sit beside your dispensing nonconformances.
How long does setup take?
The target for a first working workflow is 8–12 weeks, depending on scope, data readiness and your team's availability. You configure and test in your own QMSdesk, and go-live takes two separately signed attestations.
Can we keep USP chapters in QMSdesk?
Yes, as reference documents. They carry their issuing body, version and issue date, and a banner makes clear they aren't internally approved. License-restricted standards can be read in the app with download switched off.
How is QMSdesk priced?
By organization tier, never per seat, and every tier includes every module. See pricing.
Build your regulatory profile
Tell us how you compound. We'll show you QMSdesk working under your regulations.
Early-stage and growth teams can apply for the 2026 Early Adopter Program.