Morsa publishes this guide. Morsa is not an ERP or QMS. Its AI agent gathers each batch’s records and missing certificates, and quality approves every release. Prices read 8 November 2026.
Quick answer
QuickBooks can stay for accounting. FDA’s software guidance puts accounting software outside validation [11]. What you add is a validated system for lots, batch records and UDI.
Year one for a 50-person maker on Cetec: about $32,000 to $107,000 in our estimate, most of it implementation (worked out below).
One vendor or two: QT9 and Cetec cover ERP and quality in one system; Business Central needs a device QMS beside it. QMS prices are in our QMS software pricing guide.
What changed on 2 February 2026
Part 820 is now short. It has six sections: scope, definitions, the ISO 13485 incorporation, QMS requirements, control of records and labeling [4]. The device history record, device master record and design history file no longer have sections of their own; ISO 13485’s records apply instead.
FDA reads more. Internal audit, supplier audit and management review reports, once shielded from inspection, can now be reviewed. So can records made before 2 February 2026 [2].
UDI: what lands in the ERP
A UDI has two parts [3]:
Device identifier (DI): fixed; it names the labeler and the model.
Production identifier (PI): variable; the lot or batch, serial number, expiration date or manufacture date, whichever appears on the label.
The labeler prints the UDI on the label in plain text and machine-readable form, and submits device data to FDA’s device database, GUDID (Global Unique Device Identification Database) [3]. Under 21 CFR 820.35, the UDI must be recorded for each device or batch, and complaint and service records must carry it too [4]. In practice the ERP assigns the PI when a batch is made, prints it through labeling, and keeps it on every shipment line.
ERP or QMS: who does what
Job | Where it lives |
|---|---|
Lot and serial genealogy, supplier to customer | ERP |
UDI per device or batch, label printing | ERP, with labeling software |
Receiving inspection, quarantine and release | ERP holds the status; QMS holds the procedure |
Production record for each batch | ERP, or an MES (manufacturing execution system) feeding it |
Approved suppliers | QMS keeps the list; the ERP blocks POs to anyone not on it |
CAPA, nonconformance, complaints | QMS, linked to the lot and UDI in the ERP |
Document control, training, design file | QMS |
Electronic signatures (21 CFR Part 11) | Both, wherever quality records are signed |
One product means one validation; two means a link to maintain between them.
Do you have to leave QuickBooks?
No law makes you leave it. FDA’s computer software assurance guidance says software for general business processes, “such as email or accounting applications”, is not used as part of production or the quality system, so its validation requirements do not apply [11]. Software that holds lot records, batch records or inspection results must be validated [11].
QuickBooks Enterprise has bills of materials, assemblies and, on Platinum and Diamond, a stock report by lot number. Intuit’s manufacturing page lists no routings, quality records or lot genealogy [16]. So the usual path for a 50-person shop is to keep QuickBooks for the books and add a manufacturing system that syncs to it: Cetec links to QuickBooks Online for $300 a month [5], and MRPeasy lists a QuickBooks Online integration on its plans [18]. When to move the accounting too is covered in QuickBooks to ERP.
What an electronic batch record holds
Our checklist for a Class II batch, replacing the paper traveler:
Work order, quantity started, quantity made and quantity released.
Every component lot consumed, with its supplier certificate.
Each routing step signed by the operator who did it, on a tablet at the station.
Inspection and test results, including any outside sterilization certificate.
The label used and the UDI (DI plus lot) [4].
Any nonconformance, with its link to the QMS.
The release signature.
QT9 describes its electronic device history record the same way: production orders, inspections and component lots tied to each serial number, signed under Part 11 [14].
A worked lot trace
A pouch supplier writes: sterile barrier pouch lot P-2291 failed a seal test. The ERP has to answer:
Question | Answer from a working ERP |
|---|---|
Which batches used lot P-2291? | 3 batches of catheter kits: K-1040, K-1041, K-1044 |
How many units, and where? | 1,800 units: 300 in quarantine, 1,500 shipped |
Who received them? | 6 shipments to 4 distributors, by UDI (DI plus lot) |
What else is at risk? | 2 open work orders reserved against the same pouch lot |
With lot genealogy in the ERP, that is one report. On paper travelers and spreadsheets it is slow and error-prone. The complaint and any correction then go in the QMS, linked to those lots.
Vendors and prices
Vendor | Device features it states | Price |
|---|---|---|
QT9 ERP and QMS | Electronic device history records, lot genealogy, UDI-DI and PI in serial formats, GS1 barcode labels; pre-validated, Part 11 [14][7] | Quote, by concurrent users [7] |
Cetec ERP | Traceability and quality built in; Compliance Bundle for Validation $850 a month [5] | $50 a user a month, 5-user minimum; shop floor users $25 [5] |
Business Central Premium | Lot, serial and expiration tracking and an item tracing page built in; UDI labels not stated [15] | $110 a user a month, paid yearly; Team Members $8 [6] |
MRPeasy | Lot traceability, serial numbers and a label editor on every plan; validation package not stated [18] | From $49 a user a month [18] |
ProShop | Machine shops making device parts; QMS built in, ISO 13485 [8] | Quote; Software Finder reports $500 to $715 a month for 5 to 10 users [9] |
NetSuite, Acumatica, Plex, QAD, Epicor Kinetic | Mid-market regulated production [10] | Quote |
Vendors rarely publish validation costs; Cetec is the exception. Ask every vendor for its validation package and its price in writing.
What year one costs: our estimate
For a 50-person Class II maker on Cetec, keeping QuickBooks Online for accounting:
Line | Year 1 |
|---|---|
15 office users: 15 × $50 × 12 | $9,000 |
15 shop floor users: 15 × $25 × 12 | $4,500 |
Compliance Bundle for Validation: $850 × 12 | $10,200 |
QuickBooks Online link: $300 × 12 | $3,600 |
Assisted implementation, Cetec’s own range | $5,000 to $80,000 [17] |
Total | $32,300 to $107,300 |
Add a separate device QMS only if Cetec’s quality features do not fit your auditor. Wider implementation ranges are in our ERP implementation cost guide.
Closing out each batch record
The ERP and QMS hold the records; someone still collects them before release. Morsa is software with an AI agent that works in your ERP, email and Teams, on whichever ERP you run, QuickBooks included.
Batch K-1044 finishes. Morsa gathers the lots consumed, inspection results and each supplier’s certificate of conformance.
The sterilization certificate is missing. Quality approved this kind of request once; under that rule Morsa asks the contract sterilizer from the quality inbox.
When it arrives, Morsa checks the lot and load numbers against the ERP and attaches it.
The quality engineer reviews the complete packet and releases the batch. Morsa never releases anything itself.
To see it on your own batches, book a 30-minute walkthrough.
Which one to pick
Your situation | Price these first |
|---|---|
50-person Class II maker, wants one system and one validation | QT9 (quote) and Cetec with its validation bundle |
Already on Microsoft 365 and Business Central | Business Central plus a device QMS (Qualio, SimplerQMS) |
Machine shop making device components | ProShop |
This week, run a mock trace on one supplier lot and time it; the answer tells you how urgent this is.
Sources
FDA, Quality Management System Regulation (QMSR): https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr (read 8 November 2026)
FDA, Quality Management System Regulation: Frequently Asked Questions: https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions (read 8 November 2026)
FDA, UDI Basics: https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics (read 8 November 2026)
eCFR, 21 CFR 820.35 Control of records, and FDA, Overview of the Quality Management System Regulation (section list): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/section-820.35 and https://www.fda.gov/media/181434/download (read 8 November 2026)
Cetec ERP, Pricing: https://cetecerp.com/pricing/ (read 8 November 2026)
Microsoft, Dynamics 365 Business Central pricing: https://www.microsoft.com/en-us/dynamics-365/products/business-central/pricing (read 8 November 2026)
QT9 Software, Pricing: https://qt9software.com/pricing (read 8 November 2026)
ProShop ERP, Aerospace ERP (built-in QMS for ISO 13485, ISO 9001 or AS9100): https://proshoperp.com/aerospace-erp/ (read 8 November 2026)
Software Finder, ProShop ERP pricing (third party, not the vendor): https://softwarefinder.com/erp-software/proshop-erp/pricing (read 8 November 2026)
ERP Research, Medical Device ERP Software: Best Systems 2026 (updated July 2026): https://www.erpresearch.com/en-us/erp-for-medical-devices (read 8 November 2026)
FDA, Computer Software Assurance for Production and Quality Management System Software, final guidance (February 2026; supersedes the final guidance issued 24 September 2025), web page and guidance document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-management-system-software and https://www.fda.gov/media/188844/download (read 8 November 2026)
SimplerQMS, Pricing: https://www.simplerqms.com/pricing/ (read 8 November 2026)
Qualio, Pricing: https://www.qualio.com/pricing (read 8 November 2026)
QT9 Software, Medical Device ERP: https://qt9software.com/erp/industry/medical-devices (read 8 November 2026)
Microsoft Learn, Track items with serial, lot, and package numbers in Business Central: https://learn.microsoft.com/en-us/dynamics365/business-central/inventory-how-work-item-tracking (read 8 November 2026)
Intuit, QuickBooks Enterprise for manufacturing: https://quickbooks.intuit.com/desktop/enterprise/industry-solutions/manufacturing/ (read 8 November 2026)
Cetec ERP, Launch and implementation pricing: https://cetecerp.com/pricing/launch (read 8 November 2026)
MRPeasy, Pricing: https://www.mrpeasy.com/pricing/ (read 8 November 2026)
