Dashboard
Compliance Calendar
| Name | Role | Start Date | Certifications | Status | Actions |
|---|
| License Type | License Number | Expiration Date | Days Left | Status | Document | Actions |
|---|
Deviation → Complaint → CAPA → Effectiveness — Full QMS Cycle
21 CFR 111.14 / 117.4 — Personnel Qualification & Training
| Employee(s) | Training Topic | Type | Mode | Trainer | Date | Result | Status | Actions |
|---|
| REC ID | Date | Material | Type | Vendor | Lot # | Qty | Inspection | ID Test | COA | Status | Actions |
|---|
Test Results Trending
Allergen Control Program
FSMA 117.135(c)(2) / FALCPA Big 9 Compliance
Ingredient Allergen Declarations
New ingredients default to Free From all allergens and must be verified before use in formulations. Click any cell to toggle: Contains / May Contain / Free From
| Ingredient | 🥛 Milk | 🥚 Eggs | 🐟 Fish | 🦐 Shellfish | 🌰 Tree Nuts | 🥜 Peanuts | 🌾 Wheat | 🫘 Soybeans | 🌱 Sesame | Action |
|---|
| Ingredient | 🥛 Milk | 🥚 Eggs | 🐟 Fish | 🦐 Shellfish | 🌰 Tree Nuts | 🥜 Peanuts | 🌾 Wheat | 🫘 Soybeans | 🌱 Sesame | Status |
|---|
Formulation Allergen Matrix
Auto-calculated from ingredient declarations. Shows allergen profile for each active formulation.
| ID | Formulation | 🥛 Milk | 🥚 Eggs | 🐟 Fish | 🦐 Shellfish | 🌰 Tree Nuts | 🥜 Peanuts | 🌾 Wheat | 🫘 Soybeans | 🌱 Sesame | Allergen Statement |
|---|
Cross-Contact Risk Assessment
Assess cross-contact risk per production line/area. Link to equipment and allergen types.
| ID | Production Line / Area | Allergens Present | Risk Level | Mitigation | Last Assessed | Status | Actions |
|---|
Allergen Cleaning Verification
Track allergen-specific cleaning events. Verify changeover between products with different allergen profiles.
| ID | Date | Equipment / Line | Previous Product | Next Product | Allergens Cleared | Method | Verified By | Result |
|---|
Label Allergen Statement Verification
Verify that product label allergen statements match the calculated allergen profile from formulation data.
| ID | Formulation | Label Statement (As Printed) | Calculated Profile | Match | Verified By | Date | Actions |
|---|
Allergen Reports
Allergen Matrix Report
Full formulation × allergen grid with Contains/May Contain/Free From status
Ingredient Declaration Report
List of all ingredients with their allergen declarations and missing declarations
Cross-Contact Risk Report
Production line risk assessments with mitigation status
Cleaning Verification Report
Allergen cleaning records with pass/fail results
Active Tasks
| Description | Type | Assignee | Priority | Due Date | Status | Actions |
|---|
Completed History
| Description | Type | Completed By | Notes | Date | Actions |
|---|
INVENTORY MANAGEMENT HUB
Bulk Materials
Manage bulk raw materials, active ingredients, and base materials requiring further processing.
Intermediate / WIP
Track work-in-progress materials, intermediate compounds, and semi-finished products.
Finished Goods
Manage completed products ready for distribution, including batch tracking and release status.
Raw Ingredients
Track ingredients with lot numbers, COA verification, expiry dates, and supplier information.
Packaging Components
Manage packaging materials by section with lot tracking, material type classification, and usage history.
Inventory Management Features
- Auto-generated lot numbers for full traceability
- Real-time stock level tracking with usage history
- Supplier and COA documentation
- Expiry date monitoring with automatic alerts
- Storage location management
- Complete audit trail of all inventory movements
- QuickBooks purchase order integration
Bulk Materials Inventory
| Lot # | Status | Item Name | Qty Produced | Current Qty | Unit | Date Produced | COA | Notes | Actions |
|---|
Intermediate / WIP Inventory
| Lot # | Status | Item Name | Qty Produced | Current Qty | Unit | Source Batch | Production Date | COA | Location | Actions |
|---|
Finished Goods Inventory
| Lot # | Product Name | Quantity | Unit | Batch # | Production Date | Expiry Date | Release Status | COA | Unit Price | Actions |
|---|
Raw Ingredients Inventory
| Lot # | Status | Ingredient Name | Class | Qty Received | Qty on Hand | Unit | Supplier | Supplier Lot | Received | Expiry | COA | Location | Actions |
|---|
Access GMP-compliant log templates for production, compliance, and quality management activities. All logs are automatically timestamped and audit-tracked.
Create New Log Entry
Access all log templates and create new entries
Log History
Search and review all historical log entries
Custom Log Builder
Build custom GMP log templates with drag-and-drop fields
MMR Records
Master Manufacturing Records — 21 CFR 111.210 compliant
QC Daily Review
Quality control sign-off on all daily logs & facility status
Daily — QC RequiredSanitation Log
Daily cleaning and sanitizer verification
DailySanitizer Concentration
Verify sanitizer PPM levels
DailyTemp & Humidity
Storage & production area monitoring
DailyPre-Op Inspection
Pre-operational line and area checks
DailyBatch Production Record (Supp)
21 CFR 111 — Dietary supplement batch documentation
ProductionBatch Production Record (Food)
21 CFR 117 — Food production batch documentation
ProductionLine Clearance (Supp)
21 CFR 111.365 — Supplement changeover verification
ProductionLine Clearance (Food)
21 CFR 117.80 — Food changeover verification
ProductionYield Reconciliation (Supp)
21 CFR 111.260 — Supplement yield accountability
ProductionYield Reconciliation (Food)
21 CFR 117 — Food batch yield accountability
ProductionLabel Reconciliation
Labels issued vs. used tracking
ProductionRework Log
Rework tracking and QA disposition
As NeededEquipment Calibration
Scale and equipment verification
ScheduledIdentity Testing (Supp)
21 CFR 111.75 — Dietary ingredient identity verification
Per ReceiptRaw Material Verification (Food)
21 CFR 117.80 — Food ingredient verification
Per ReceiptEnvironmental Monitoring
Micro swab and surface testing
ScheduledWater Quality
Water potability and testing records
ScheduledAllergen Cleaning Verification
Post-changeover allergen removal verification
As NeededFacility Inspection
Routine facility condition checks
WeeklyMaintenance Log (Supp)
21 CFR 111.27 — Supplement equipment maintenance
As NeededMaintenance Log (Food)
21 CFR 117.40 — Food equipment maintenance
As NeededPest Control
Pest sightings, treatments, and PCO visits
Scheduled + As NeededGlass & Brittle Breakage (Supp)
Breakage incident — QA release required
IncidentGlass & Brittle Breakage (Food)
SQF / BRCGS / 21 CFR 117 — Food incident
IncidentEmployee Health & Hygiene
Illness reporting per FDA requirements
As NeededVisitor & Contractor Log
Track all non-employee facility access
DailyReceiving & Inspection
Incoming material receipt, inspection & COA
Full ModuleShipping & Distribution
Outbound shipment documentation
As NeededWaste Disposal (Supp)
21 CFR 111.380 — Witnessed supplement disposal
As NeededWaste Disposal (Food)
21 CFR 117.35(e) — Food waste disposal
As NeededGMP Logging Best Practices
- All logs are timestamped and user-attributed automatically
- Logs cannot be deleted, only amended with notes (audit trail)
- Complete logs immediately after the activity is performed
- Use clear, factual language without ambiguity
- Sign/initial all completed logs with your credentials
- Report any deviations or non-conformances immediately
Select a log template below to begin a new GMP-compliant record. All entries are timestamped, user-attributed, and audit-tracked.
QC Daily Review
Quality control sign-off on all daily logs & facility status
Daily — QC RequiredSanitation Log
Daily cleaning and sanitizer verification
DailySanitizer Concentration
Verify sanitizer PPM levels
DailyTemp & Humidity
Storage & production area monitoring
DailyPre-Op Inspection
Pre-operational line and area checks
DailyVisitor & Contractor Log
Track all non-employee facility access
DailyMaster Manufacturing Records
21 CFR 111.210 — Create and manage MMR documents
Per FormulationBatch Production Record (Supp)
21 CFR 111 — Dietary supplement batch documentation
ProductionBatch Production Record (Food)
21 CFR 117 — Food production batch documentation
ProductionLine Clearance (Supp)
21 CFR 111.365 — Supplement changeover verification
ProductionLine Clearance (Food)
21 CFR 117.80 — Food changeover verification
ProductionYield Reconciliation (Supp)
21 CFR 111.260 — Supplement yield accountability
ProductionYield Reconciliation (Food)
21 CFR 117 — Food batch yield accountability
ProductionLabel Reconciliation
Labels issued vs. used tracking
ProductionRework Log
Rework tracking and QA disposition
As NeededEquipment Calibration
Scale and equipment verification
ScheduledIdentity Testing (Supp)
21 CFR 111.75 — Dietary ingredient identity verification
Per ReceiptRaw Material Verification (Food)
21 CFR 117.80 — Food ingredient verification
Per ReceiptEnvironmental Monitoring
Micro swab and surface testing
ScheduledWater Quality
Water potability and testing records
ScheduledAllergen Cleaning Verification
Post-changeover allergen removal verification
As NeededFacility Inspection
Routine facility condition checks
WeeklyMaintenance Log (Supp)
21 CFR 111.27 — Supplement equipment maintenance
As NeededMaintenance Log (Food)
21 CFR 117.40 — Food equipment maintenance
As NeededPest Control
Pest sightings, treatments, and PCO visits
Scheduled + As NeededGlass & Brittle Breakage (Supp)
Breakage incident — QA release required
IncidentGlass & Brittle Breakage (Food)
SQF / BRCGS / 21 CFR 117 — Food incident
IncidentEmployee Health & Hygiene
Illness reporting per FDA requirements
As NeededReceiving & Inspection
Incoming material receipt, inspection & COA
Full ModuleShipping & Distribution
Outbound shipment documentation
As NeededWaste Disposal (Supp)
21 CFR 111.380 — Witnessed supplement disposal
As NeededWaste Disposal (Food)
21 CFR 117.35(e) — Food waste disposal
As NeededGMP Logging Best Practices
- All logs are timestamped and user-attributed automatically
- Logs cannot be deleted, only amended with notes (audit trail)
- Complete logs immediately after the activity is performed
- Use clear, factual language without ambiguity
- Sign/initial all completed logs with your credentials
- Report any deviations or non-conformances immediately
Log Drafts
Logs saved as drafts appear here. Click Resume to continue filling out a draft, or Submit from within the log to finalize it.
Record Archive
| Date | Document Type | Submitted By | Actions |
|---|
Custom Log Builder
Create New Custom Log Template
EditingBuild a custom GMP log template by adding fields and tables. Your custom logs will appear alongside built-in templates.
E-signatures include name, role, timestamp, and are captured when the log is submitted.
Log Sections
Build your log layout by adding form field and table sections. Drag sections up/down to arrange them in any order. Facility Name, License #, and Date are auto-included at the top.
No sections added yet. Click the buttons above to add form field sections or table sections.
Live Preview
Your log preview will appear here as you build it.
Saved Custom Log Templates
No custom logs created yet.
FDA-compliant Master Manufacturing Records per 21 CFR 111.205–111.210. Each MMR documents the complete manufacturing procedure for a formulation including component lists, manufacturing instructions, theoretical yields, packaging, and two-person verification points.
| Vendor ID | Company Name | Category | Contact | Status | Qual. Date | Expiry Date | COA | Rating | Docs | Actions |
|---|
Vendor Verification Document Suite
FDA & GMP-compliant document templates for vendor qualification per 21 CFR 111.75(a). Download blank templates, send to vendors for completion, then upload the signed/completed forms to each vendor’s file.
GMP Vendor Qualification
- All material suppliers must be qualified before first purchase under 21 CFR 111.75(a) (Supplements) / 117.415 (Food)
- Vendor qualification requires documented COA verification, quality agreement, and audit (if applicable)
- Re-qualification is required annually or when quality issues arise
- Vendors on hold cannot supply materials until requalified
- Maintain records of all vendor audits, quality events, and communications
Add New Vendor
Vendor Documents
Upload Completed Document
Create Formulation
| Check | Frequency | Specification |
|---|
| Ingredient | % of Batch | Amount | |
|---|---|---|---|
| -- |
| Component | Quantity | Display Unit | |
|---|---|---|---|
Create Production Order
New Sales Order
| Product (Finished Good) | Qty | List Price | Pricing Type | Adj % | Sell Price | Line Total |
|---|
Add Customer
Create Invoice
Create Shipment
Certificate of Analysis
Batch Production Record - From Order
21 CFR 111.75(a), 111.80, 111.83, 117.415 — Formal corrective action process for vendor non-conformances
| SCAR ID | Vendor | Severity | Category | Issue Description | Status | Issued | Deadline | Linked | Actions |
|---|
Supplier SCAR Program — Regulatory Basis
- 21 CFR 111.75(a): Suppliers must be qualified; non-conformances require documented corrective action
- 21 CFR 111.80 & 111.83: Components must meet identity, purity, strength, and composition specifications
- 21 CFR 117.415: Records of corrective actions must be maintained and available for FDA review
- 21 CFR 117.150: Corrective actions addressing the root cause and preventing recurrence
- FDA 483 Citation #3: “Procedures not followed” — vendor non-conformance must have traceable corrective action workflow
- SCAR workflow: Issue → Vendor Response → Investigation → Corrective Action → Verification → Closure
- Critical SCARs require response within 5 business days; Major within 10; Minor within 20
- All SCARs impact vendor scorecard rating and requalification decisions
| Lot # | Item Name | Category | Supplier | Qty On Hand | Expiry Date | Days Until | FEFO Status | Release Status | Actions |
|---|
| Date | Operator | FEFO Lot (Suggested) | Selected Lot | Item | Justification | Deviation ID | BPR / PO Ref |
|---|
FEFO Enforcement — Regulatory Basis
- 21 CFR 111.365: Components must be used in accordance with first-expiry-first-out principles to prevent use of expired or degraded materials
- 21 CFR 111.370(a): Components used in manufacturing must meet their established specifications — expired components fail this requirement
- 21 CFR 111.455–475: Holding and distribution controls require proper stock rotation and expiry management
- 21 CFR 117.93: Supplier verification activities must ensure raw materials are handled under appropriate stock rotation and FEFO principles
- 21 CFR 117.80(c)(2): Raw materials and other ingredients must be handled and stored in a manner that prevents adulteration — proper rotation prevents use of expired materials
- Override protocol: Any deviation from FEFO pick order requires documented justification and auto-creates a Deviation record per §111.113 / §117.150
- Expired lot auto-block: Materials past their expiry date are automatically blocked from use in production — no override permitted
| Program ID | Foreign Supplier | Country | Materials Supplied | Hazard Analysis | Verifications | Next Re-Eval | Status | Actions |
|---|
FSVP Requirements — Regulatory Basis
- Part 1.502: FSVP applies to importers of food (including dietary supplements) into the United States
- Part 1.504: Hazard analysis required for each food imported — biological, chemical (including radiological), physical hazards + economic adulteration
- Part 1.505: Foreign supplier evaluation based on hazard analysis, compliance history, and food safety practices — re-evaluate at least every 3 years
- Part 1.506: Verification activities: on-site audit, lot-by-lot testing, sampling/testing, review of supplier food safety records
- Part 1.508: Corrective actions required when verification activities indicate food safety problems
- Part 1.509: FSVP Qualified Individual must have training or experience in food safety systems
- Part 1.510: Records must be maintained for at least 2 years
| Date | Group | Original Ingredient | Substituted With | Formulation | Reason | Change Control | Operator |
|---|
Ingredient Substitution — Regulatory Basis
- 21 CFR 111.70: Specifications must be established for each component used — substitutions require re-validation against these specifications
- 21 CFR 111.210: Master Manufacturing Records must identify each component — ingredient changes must be reflected in the MMR
- 21 CFR 111.30(d): Changes to production and process controls must follow documented change control procedures
- FALCPA / FASTER Act: Any ingredient substitution that introduces a new allergen (Big 9: Milk, Eggs, Fish, Shellfish, Tree Nuts, Peanuts, Wheat, Soybeans, Sesame) is automatically blocked
- Supplement Facts panel: Active ingredient substitutions auto-flag the label for review to ensure label accuracy per 21 CFR 101.36
Full landed cost calculation per 111.210 MMR — ingredient + overage + packaging + labor + overhead → margin analysis. Supports what-if scenario modeling and cost history tracking.
Landed Cost Calculator
Margin Analysis — All Active Formulations
Compares landed cost vs. selling price for every active formulation. Set selling prices below or in Ingredient Pricing tab.
What-If Scenario Modeling
Model the cost impact of ingredient price changes or substitutions before committing.
Cost History & Snapshots
Historical cost snapshots per formulation. Click "Snapshot All Costs" to record current costs, or save individual snapshots from the Landed Cost tab.
Ingredient & Packaging Pricing
Unit prices drive all cost calculations. Prices can be auto-pulled from most recent PO or set manually. Packaging pricing follows below.
Packaging Pricing
Calculates net material requirements from production orders against available inventory (FEFO-adjusted). Generates PO suggestions when stock falls below reorder points. Per 21 CFR 111.153–160 receiving planning and 111.365 component management.
Material Coverage Status
Demand Breakdown by Production Order
Shows material demand generated by each active production order (Pending + In Progress).
Suggested Purchase Orders
Auto-generated PO recommendations for materials below reorder point or in shortage. Click "Create PO" to generate a purchase order.
Planning Horizon
Projects material needs by week based on production orders with due dates within the planning horizon.
MRP Run History
Log of all MRP planning runs with key metrics at time of execution.
| Order ID | Product | Formulation | Type | Customer | Qty | Priority | Created | Due Date | Status | Assigned To | Actions |
|---|
21 CFR 111.123–127 — Quality control must review and approve/reject each batch before release for distribution.
21 CFR 101.36 — Auto-generate compliant Supplement Facts panels from formulation data with FDA Daily Value calculations.
| Label ID | Product Name | Formulation | Serving Size | Ingredients | Version | Status | Last Modified | Actions |
|---|
Label Preview
Create Supplement Facts Label
Active dietary ingredients listed in the Supplement Facts panel. %DV auto-calculates from the FDA Daily Value reference database (21 CFR 101.36).
| Dietary Ingredient | Potency % | Amount / Serving | Unit | FDA DV Lookup | % DV | |
|---|---|---|---|---|---|---|
Non-active ingredients (excipients, fillers, capsule shells, etc.) listed in descending order by weight per 21 CFR 101.36(c).
Auto-generated from Allergen Control data when a formulation is linked. Review and edit as needed.
Select claims to include. Claims are validated against allergen and formulation data.
DSHEA Section 6 / FD&C Act 403(r)(6) / FTC Health Products Compliance — Manage claims, substantiation, disclaimers & FDA notifications.
"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
This disclaimer must appear on the label of any product bearing a structure/function claim. The system auto-generates this for all approved claims.
| Claim ID | Status | Claim Text | Type | Products | FTC Met? | FDA Notified | Flags | Actions |
|---|
New Structure/Function Claim
This language may be interpreted as a drug claim by FDA.
Loading formulations...
Select all products that carry this claim on their label.
Label Disclaimer Preview
Dietary supplement products must contain at least the amount of each dietary ingredient declared on the label (21 CFR 101.36). Overages must be configured to ensure label claims are met through the end of shelf life, accounting for potency degradation over time.
New Potency Profile
Configure label claim, overage percentage, actual assay, and degradation rate for each ingredient. The system auto-calculates adjusted quantities, release compliance, and projected potency at expiry.
| Ingredient | Formula Qty | Label Claim | Overage % | Target (w/ Overage) | Actual Assay % | Adj. Qty Needed | Degrad. %/mo | Proj. at Expiry | Release ✓ | Expiry ✓ | Cost/Unit ($) |
|---|
| PO # | Date | Vendor / Materials | Total ($) | Delivery | Status | Received | Actions |
|---|
Sales Orders
Create and manage customer orders
Invoices
Generate and track invoices
Shipments
Track deliveries and shipments
Customers
Manage customer database
| Order # | Customer | Order Date | Items | Total | Status | Actions |
|---|
| Invoice # | Customer | Sales Order | Invoice Date | Due Date | Amount | Status | Actions |
|---|
| Shipment # | Sales Order | Customer | Lots | Carrier | Tracking # | Ship Date | Status | Actions |
|---|
| ID | Company Name | Contact | Phone | Salesperson | Total Orders | Actions |
|---|
Manage fulfillment, pick/pack/ship workflow, and warehouse locations
| Fulfillment # | Sales Order | Customer | Items | Priority | Release Gate | Status | Created | Actions |
|---|
| Pick List # | Fulfillment Orders | Items | Assigned To | Status | Created | Actions |
|---|
| Pack Record # | Pick List | Sales Order | Packages | Allergen Alert | Status | Actions |
|---|
| Shipment # | Sales Order | Customer | Carrier | Tracking # | Packages | Status | Actions |
|---|
| Location ID | Zone | Aisle-Shelf-Bin | Assigned Lots | Capacity | Status | Actions |
|---|
Accounts receivable, accounts payable, financial reporting, and integrations
| Invoice # | Customer | Invoice Date | Due Date | Total | Paid | Balance | Aging | Actions |
|---|
Payment History
| Payment # | Customer | Invoice | Amount | Date | Method |
|---|
| Bill # | Vendor | PO # | Bill Date | Due Date | Total | Paid | Balance | Status | Actions |
|---|
Vendor Payment History
| Payment # | Vendor | Bill | Amount | Date | Method |
|---|
Manage Standard Operating Procedures, controlled documents, and uploaded files with full version control and GMP-compliant document management.
SOP Library
View, manage, and search all SOPs and controlled documents with version tracking.
SOP Builder
Create new SOPs from scratch using GMP-compliant structured templates.
Document Cabinet
Upload and organize licenses, COAs, lab results, vendor docs, and more.
GMP Document Management Features
- Version-controlled SOPs with complete revision history
- Built-in SOP builder with GMP-compliant structure (Purpose, Scope, Procedure, Training)
- Upload external documents (PDF, Word, Excel, Images)
- Document Cabinet for licenses, COAs, audit reports, and vendor qualifications
- Document status tracking (Draft → Review → Approved → Effective)
- Automatic review date scheduling and expiration tracking
Manage all Standard Operating Procedures and controlled documents
| Doc ID | Type | Title | Rev | Status | Eff. Date | Review Due | Owner | Actions |
|---|
No documents found
Create your first SOP or upload a document to get started.
Create GMP-compliant Standard Operating Procedures
Document Information
1. Purpose
2. Scope
3. Responsibilities
4. Materials & Equipment
5. Procedure Steps
6. Safety & Compliance Notes
7. Related Documents
8. Training Requirements
Central repository for all GMP, regulatory, and facility documents — organized by compliance area
📁 GMP Document Sections
📋 GMP Document Compliance
FDA-required documents per 21 CFR 111/117. Green = on file, Red = missing, Yellow = expired or expiring.
Upload to Document Cabinet
Document Control Center
This section has been upgraded. Use the Documents hub for full document management.
SOP Builder
| Role | Responsibility | |
|---|---|---|
| Term | Definition |
|---|
| Item | Specification / Notes |
|---|
| Step | Instruction | Critical Params / Notes | |
|---|---|---|---|
| 1 |
| Rev | Date | Description of Change | Author | |
|---|---|---|---|---|
| Role | Name | Date | Status | |
|---|---|---|---|---|
Upload External Document
Document Viewer
Forward & backward trace across all inventory, production, and distribution records
21 CFR 111.560-570 — Complaint intake, investigation, adverse event flagging, CAPA linking
21 U.S.C. § 379aa-1 — Serious adverse events must be reported to FDA within 15 business days
21 CFR 111.503–535 (Subpart N) — Quarantine, QC Review, Disposition & Destruction Records
Tracks New Dietary Ingredient (NDI) notifications per DSHEA Section 8 and 21 CFR 190.6. Ingredients marketed before October 15, 1994 are classified as pre-DSHEA (grandfathered). All others require a 75-day pre-market notification to FDA.
NDI Register
75-Day Pre-Market Notification Tracker
Per 21 CFR 190.6(a), manufacturers must notify FDA at least 75 days before marketing a dietary supplement containing an NDI. The countdown begins on the notification submission date.
Product-to-NDI Cross-Reference
Shows which products (formulations) use each NDI ingredient. Auto-detected from formulation ingredient lists.
Safety Evidence Dossiers
Safety evidence supporting each NDI notification, aligned with FDA NDI Guidance: history of use, toxicology studies, clinical trials, and other references.
Tracks FDA facility registration per FSMA Section 415 and 21 CFR Part 1 Subpart H. All domestic and foreign facilities that manufacture, process, pack, or hold food or dietary supplements for U.S. consumption must register with FDA. Registrations must be renewed biennially during October 1 – December 31 of even-numbered years.
Registered Facilities
Biennial Renewal Tracker
Per 21 CFR Part 1.234, registrations must be renewed biennially during the period beginning on October 1 and ending on December 31 of each even-numbered year. FDA may suspend a facility's registration if renewal is not completed.
Registration & Renewal History
Chronological log of all registration events, renewals, amendments, and status changes.
FSMA Section 415 Compliance Status
Compliance checklist per FSMA Section 415 / 21 CFR Part 1 Subpart H registration requirements. All items must be current for FDA inspection readiness.
Cross-cutting inspection readiness assessment against all 21 CFR 111 Subparts (A–P) and 117. Monitors open items across all quality modules, tracks self-assessment compliance, and supports FDA 483 response management. Target: every record retrievable in <10 minutes.
Open Items Tracker
Live cross-module view of all unresolved items that could trigger a 483 observation. Items are pulled in real-time from Deviations, CAPAs, Change Controls, SCARs, Training, Equipment, and Complaints.
Self-Assessment Checklist — 21 CFR 111 / 117
Pre-inspection self-assessment aligned with FDA ORA inspection checklist categories. Check items that are compliant. Unchecked items represent inspection risk areas.
Record Retrieval Drill
Simulates an FDA inspector requesting a random record. Start the drill, navigate to the correct record, then stop the timer. Target: <10 minutes per record. Tracks your retrieval history for trend analysis.
Mock Inspection Schedule & History
Schedule and document internal mock inspections. Record findings, observations, and corrective actions. Best practice: conduct quarterly mock inspections.
FDA 483 Response Tracker
Track FDA Form 483 observations received during inspections. Per FDA guidance, facilities must respond within 15 business days. Links observations to corrective actions (CAPAs).
Inspector Document Package Generator
Pre-compile commonly requested documents for FDA inspections. Having these ready reduces retrieval time and demonstrates organizational preparedness.
Manages R&D trial batches, stability studies, prototype formulations, and scale-up documentation per 21 CFR 111.303–325 (Subpart J — Laboratory Operations). Supports lab→pilot→production handoff workflow with full traceability. R&D batches are kept separate from production batches to maintain GMP integrity.
Prototype Formulation Versions
R&D prototype formulations are versioned separately from production formulations. Each version tracks ingredient changes, dosage form trials, and trial batch links. Only approved prototypes may be promoted to production formulations.
Stability Study Tracker
Tracks accelerated and real-time stability studies per ICH Q1A guidelines adapted for dietary supplements. Monitors time-point testing, potency degradation, and supports shelf-life determination.
Trial Batch Register
Scale-Up Documentation
Documents the scale-up process from lab scale → pilot scale → production scale. Captures process parameter changes, equipment differences, yield analysis, and critical quality attributes at each scale.
R&D-to-Production Handoff
Formal transfer of formulation, specifications, and analytical methods from R&D to Production. Requires QA sign-off and creates linked production formulation, BPR template, and specification records. Ensures 21 CFR 111.210 MMR compliance from day one.
Reports & Inventory History
Generate Reports
Report Preview
Training Record Reports
Generate individual or company-wide training reports with completion status, retraining due dates, and compliance gaps. Required per 21 CFR 111.14 / 117.4.
Sales Commission Report
Select a salesperson to view all their assigned accounts, order history, and commission totals. Manage your sales team in Settings.
Assigned Accounts
| Customer | Contact | Orders | Total Sales | Commission |
|---|
Order Details
| Order ID | Customer | Date | Items | Status | Total | Commission |
|---|
Select a salesperson to view their commission report
Add salespeople in Settings, then assign them to customers.
Product Royalty Report
Select specific products and a date range to calculate royalties/commissions earned on retail and wholesale sales.
| Product | Channel | Units Sold | Revenue | Rate | Royalty Earned |
|---|
▾ Order Line-Item Detail
| Order ID | Date | Customer | Product | Channel | Qty | Unit Price | Line Total | Royalty |
|---|
Select products, set your date range and rates, then click Generate
Inventory Overview & History
Inventory Movement Log
All inventory movements including BPR deductions, manual adjustments, and receipts.
Complete audit trail of all system actions. Every data change, approval, and disposition action is recorded.
Admin-only section. Deleted records are retained for 30 days before automatic permanent purge. Restore items to their original location or permanently delete them.
Facility Information
This information appears in the header across all pages.
upload
Upload your company logo (PNG, JPG, SVG). Appears on exported COAs, reports, and logs.
Module Controls
Security Settings 21 CFR Part 11
Auto-logout after inactivity. Warning shown 5 min before. Min 5, max 120.
Lock account after N failed attempts for 15 minutes.
System Information
Low-Stock Alerts
Display dashboard alerts when inventory falls below a configurable threshold. Choose between percentage-based (% of received qty consumed) or fixed-quantity alerts.
Each inventory item can have its own alert threshold. In Edit mode, use the Low Stock column to set a custom percentage or fixed threshold per item. Items set to "Default" will use the global setting above.
Example: Sugar received 5,000g with 60% consumed threshold → alerts at ≤2,000g remaining. Gelatin received 1,000g → alerts at ≤400g.
SOP Auto-Link Defaults
When you open a log, the SOP Reference field auto-populates with the best match from your SOP Library. If you manually select a different SOP, that preference is saved for future entries. All auto-filled fields remain fully editable.
| Log Type | Default Ref | Linked SOP | Status | Action |
|---|
💡 SOPs are matched by department, keywords, and document ID patterns. Create SOPs in the SOP Library to enable auto-linking. Override preferences are saved and persist across sessions.
User Management
| Username | Role | Access Level | Departments | Password | Status | Action |
|---|
Section Access Matrix Control which access levels can view each section
| Section | Admin | Full | Limited | View Only |
|---|
Activity Log
Complete audit trail of all system activity. Every click, navigation, and action is logged.
| Timestamp | User | Action Type | Details |
|---|
Sales Team Management
Manage your sales team. Assign salespeople to customers to track commissions. Commission rates set here are defaults — you can override them per report.
| Name | Default Commission % | Assigned Accounts | Status | Actions |
|---|
External Integrations
QuickBooks Online
Sync inventory assets and COGS automatically.
ShipStation
Automated fulfillment and tracking updates.
Shopify
Sync orders, inventory, customers, and products.
Data Management
Export Data
Download complete system backup as JSON file.
Import Data
Restore from a previous backup file.
Reset System
Clear all data and reset to defaults. This cannot be undone.