Compounding pharmacy compliance, connected.
CompliRx connects daily monitoring, cleaning, personnel qualifications, controlled documents and quality follow-up for compounding pharmacy teams.
Everything, connected.
CompliRx is where the compliance work happens.
Not a binder you fill in afterwards. Readings, results and cleaning are recorded where the work is done, and the follow-up stays attached to them. The sample facility below is fictional.
A humidity drift gets an owner in minutes.
Monnit, SafetyCulture and Temp Stick readings land on the room they belong to, judged against that room's limits.
When a reading leaves its band, the room turns red, the alert names the room and the limit, and the person who acknowledges it records why.
Environmental monitoring →A failed plate opens its own CAPA.
A surface result over the action level opens a CAPA with severity and a due date already set.
Containment, the re-sample and the effectiveness check are recorded on the same record, and each step is written to the audit trail as it happens.
CAPA workflows →Every cleaning entry lands on the board as it happens.
Daily, weekly and monthly tasks for every room on one board, each entry stamped with who cleaned and when.
Sporicidal entries carry the reagent lot and expiry, and an expired bottle cannot be chosen.
Digital cleaning logs →Configure, complete, prove.
One operating loop connects the facility, the people doing the work, and the evidence an inspector expects.
Define the facility once
Map rooms, classifications, equipment, personnel roles, cleaning protocols, and required records. CompliRx turns that facility profile into the work your standards require.
Run daily compliance work
Teams complete monitoring, cleaning, equipment checks, training, and document acknowledgments in one workflow, with timestamps, signatures, and exceptions captured as the work happens.
Prove it to an inspector
Every reading, task, qualification, document version, signature, and CAPA threads into inspection-ready reports. No binder assembly the night before.
The work you do by hand, handled.
Four things sterile compounding teams tell us eat their week, and what CompliRx does with each.
“We log temps on a clipboard, so an excursion sits unnoticed until the next walk-through.”
Sensors stream in continuously. An out-of-range reading pages the designated person and opens an investigation the same minute it happens.
“Garbing, gloved-fingertip, and media-fill records live across three binders and a spreadsheet.”
Competency assessments schedule themselves by USP Category, capture dual e-signatures, and land in each employee's record with expiry tracking.
“Cleaning gets done, but the log gets backfilled on Friday afternoon.”
Each room's cleaning task is timestamped at completion and verified by a manager. There is no Friday reconstruction to explain to an inspector.
“When an inspector walks in, we lose two days assembling a binder.”
The evidence packet stays current as you work. Hand an inspector a scoped token link and they read the live record without you printing a page.
Every compliance record, connected.
Configure your facility once. CompliRx coordinates monitoring, cleaning, equipment, personnel, training, controlled documents, and inspection reporting from there.
Environmental monitoring
Connect automated readings, sensor health, manual backup observations and viable sampling to the room and follow-up record.
Personnel training & competency
Track role-based learning, garbing, media-fill and gloved-fingertip results, due dates and the evidence supporting a qualification decision.
Version-controlled SOPs
Manage document versions, author/reviewer/approver steps and employee acknowledgments. Adapt templates to your approved procedures and retain the revision history.
FDA inspection readiness
Compliance scoring across 8 categories, inspector view, mock inspections, and Form 483 response tracking.
Cleaning & disinfection
Agent registry with active ingredients, EPA registrations, and sporicidal rotation tracking. Digital cleaning logs with timestamped entries and manager verification.
CAPA workflows
Open, investigate, resolve, close. Full lifecycle tracking with deadlines, escalation, linked documentation, and automatic triggers from environmental excursions.
One platform, configured to your classification.
Config-driven onboarding provides facility-specific compliance for 503A pharmacies, 503B outsourcing facilities, home infusion pharmacies, ambulatory infusion centers, veterinary compounders, hospital pharmacies, and health-system pharmacy departments.
503A compounding pharmacies
Configure your rooms, PECs, and cleaning protocols during onboarding. CompliRx schedules your environmental monitoring, cleaning, and competency assessments around your exact setup, then keeps every employee's training and documentation in the same record.
503B outsourcing facilities
FDA-registered facilities with multi-room layouts and multiple PEC types. CompliRx handles the conditional logic: HD overlays, state-specific requirements, and PEC-specific cleaning and monitoring across one connected system.
Home & ambulatory infusion facilities
Purpose-built setup for home infusion pharmacy operations and outpatient infusion centers. Coordinate medication-storage monitoring, cleaning, equipment, staff competency, controlled documents, CAPA, and survey evidence across pharmacy, clinical, and operations teams.
Hospital pharmacies
The same environmental-monitoring, training, and inspection-readiness loop supports hospital compounding and pharmacy operations. Hospital pharmacies and health-system pharmacy departments can connect daily work and supporting records in CompliRx.
Hospital pharmacies and health systems
CompliRx serves hospital pharmacies and health systems, extending its compounding pharmacy focus to health-system pharmacy departments and hospital sterile compounding operations. Explore how environmental monitoring, personnel qualifications and controlled procedures relate to your team’s work.
Explore hospital pharmacy and health-system compliance workflows →
Document the basis for peptide compounding decisions.
Review the exact substance under the applicable 503A or 503B pathway, and retain the source, review date, supplier evidence and approved procedure. A category label alone does not authorize compounding.
Bring one record request to the demo.
Choose a sensor outage, an overdue qualification or a revised SOP. Ask us to show the original observation, responsible person, review history and follow-up in the same facility. Use your own acceptance criteria before changing a controlled process.
Check supported integrations, review security and access controls, and see the published product changes.
Does software establish compliance?
No. CompliRx organizes execution and evidence. Your pharmacy determines applicable requirements, approves procedures, qualifies personnel and validates its intended use of electronic records. Start with the workflow and standards map.
For substance eligibility, use FDA’s bulk-substance framework and our 503A/503B pathway guide.
See CompliRx on a facility like yours.
A walkthrough of your complete compliance program—from facility controls and daily work to personnel, documents, and inspector-ready reporting.