AEGCompliance Ops™ gives your team a defensible, audit-ready compliance record — lot tracking, chain of custody, SOP management, and DSCSA reporting — in one place. No spreadsheets. No guessing.
Free to start. No credit card required. Full functionality from day one.
Most peptide clinics are one FDA inspection away from a compliance crisis they didn't know they had.
The FDA's DSCSA requirement applies to all trading partners in the pharmaceutical supply chain — including 503B outsourcing facilities. Transaction information, statement, and verification (T3) records must be captured and retained. Paper logs don't cut it.
When a lot is recalled, can you immediately identify every patient it was administered to, on what date, by whom, and from which vial? If your answer involves a search through paper records or a spreadsheet, you have a problem.
FDA 21 CFR Part 211 requires that audit trails be tamper-resistant and cannot be altered. A shared Google Sheet edited by six staff members is not an audit trail. It's a liability.
Which lots are about to expire? Which have been in quarantine too long? Which SOPs haven't been acknowledged by your newest hire? You can't manage what you can't see — and right now, most clinics can't see it.
AEGCompliance Ops™ is built specifically for clinics and facilities handling peptides and compounded products. It tracks what matters — lot custody chains, operator actions, SOP acknowledgments — and creates an audit record that holds up to regulatory scrutiny.
Designed from the ground up for FDA inspection readiness, DSCSA compliance, and USP protocol adherence.
Receive lots from your 503B/503A vendor with full documentation: lot number, manufacturer, API source, COA reference, quantity, and receiving operator. Every receipt is an immutable audit event.
Every movement of every lot — from quarantine to release to administration — is logged with operator identity, timestamp, location, and a detailed note. No gaps. No ambiguity.
Built-in SOP library aligned to USP 797 and USP 800, plus the ability to add your facility's own SOPs. Every acknowledgment is digitally signed with operator name, role, and timestamp.
All lot movements, SOP acknowledgments, and status changes generate append-only audit events. Delete and modify operations are technically blocked — not just discouraged by policy.
When a manufacturer recall hits, you need to find every patient affected in minutes, not hours. AEGCompliance Ops maintains the patient-facing lot linkage your team needs to respond fast and accurately.
The PWA runs full-featured without internet connectivity. Floor operators stay productive during outages. All data syncs automatically when the connection returns.
Automatic capture and organization of DSCSA-required transaction information and verification records. Export EPCIS-ready data in standard formats for regulatory submission.
Operators, supervisors, and compliance officers each have their own access level. Every action is attributed to a specific individual — accountability without friction.
Designed for the floor operator first. Compliance officers and auditors benefit automatically.
Open the lot receipt form, scan or enter the lot number, attach the COA reference, and confirm the receiving operator. The lot is now in your system with a full audit trail from moment one.
Every time a lot changes location or status — quarantine to release, storage to administration — log it in under 30 seconds. The chain of custody builds itself.
When an inspector walks in, pull your complete audit log as a CSV or PDF. Every lot, every movement, every SOP acknowledgment — timestamped, attributed, and ready to present.
Start free. Scale as your practice grows. Cancel anytime.
For small peptide clinics and solo practitioners getting serious about compliance.
For growing clinics with multiple providers and a real need for DSCSA documentation.
For multi-location facilities, 503B outsourcing operations, and chains requiring centralized compliance.
All plans include a 14-day free trial. No credit card required to start.
Spreadsheets and paper logs feel like enough — until an inspection or recall changes everything.
| Capability | AEGCompliance Ops™ | Spreadsheets / Paper |
|---|---|---|
| Tamper-resistant audit trail | ✓ Yes | ✗ No |
| DSCSA transaction record capture | ✓ Yes | ✗ No |
| Lot-to-patient traceability | ✓ Yes | ✗ No |
| Offline operation on the floor | ✓ Yes | ⚠ Partial |
| SOP acknowledgment with sign-off | ✓ Yes | ✗ No |
| Recall response in minutes | ✓ Yes | ✗ No |
| Expiration tracking & alerts | ✓ Yes | ⚠ Manual |
| Works during internet outage | ✓ Yes | ✗ No |
| Multi-operator with accountability | ✓ Yes | ⚠ Shared access |
| One-click audit export | ✓ Yes | ✗ No |
If you have a question not answered here, reach out — we'll add it.
Start with a free account today. Full Professional features for 14 days. No credit card required.