Nuclear manufacturing software with NQA-1 pedigree as native platform behaviour, not a paper QA program.
10 CFR 50 Appendix B eighteen criteria, NQA-1 Part I / II compliance, 10 CFR Part 21 defect and non-conformance reporting, ASME NCA-3800 material controls and safety-related supplier qualification — all evidenced with signed, hash-chained records. Built for reactor component fabricators, safety-related suppliers and DOE prime contractors.
You're shopping for nuclear-grade quality software because a prime just added you to their 10 CFR 50 App B qualified supplier list and your QMS is commercial-grade.
10 CFR 50 App B criteria live in a paper QA manual, not in the workflow
NQA-1 Part I / II evidence is reconstructed for each triennial audit
10 CFR Part 21 evaluations are ad-hoc — no clock, no evidence trail
Safety-related vs commercial-grade dedication (CGD) lives in engineering memory
ASME material traceability (heat / lot / CoC) doesn't reach the traveler
Supplier audit and re-qual runs in a spreadsheet
Nuclear quality that survives an NRC or DOE oversight visit.
10 CFR 50 App B (18 criteria)
Organisation, QA program, design control, procurement document control, instructions/procedures/drawings, document control, control of purchased items, identification & control of materials, control of processes, inspection, test control, M&TE, handling/storage/shipping, inspection & test status, non-conforming materials, corrective action, QA records, audits — all modeled.
NQA-1 Part I + II compliance
Requirements 1–18 evidence with the subpart 2.1 (fabrication), 2.4 (installation & testing), 2.7 (software) and 2.14 (commercial-grade item dedication) supplements as live workflows. Not a binder — the QA program IS the platform.
10 CFR Part 21 evaluation
Deviation and non-conformance triage against Part 21 reportability with named evaluator, technical review, 60-day evaluation clock, board-level notification workflow, and NRC filing evidence.
Commercial-grade dedication (CGD)
EPRI NP-5652 / TR-3002002982 method 1–4 dedication packages — critical characteristics, acceptance criteria, verification method, dedicating entity records — captured per lot, tied to the traveler.
ASME NCA-3800 material control
Certified Material Test Report (CMTR) capture, heat / lot / serial traceability from receipt through installation, N-stamp and NPT-stamp evidence retention.
Safety-related supplier program
ASL (Approved Suppliers List) with scope of supply, audit history, corrective action status, NIAC / NUPIC audit reuse and triennial re-qualification workflow.
What changes when nuclear quality is one system.
- Triennial NUPIC / NIAC audit prep drops from months to weeks
- 10 CFR Part 21 evaluations start on day 1, not day 45
- CGD packages are attached to the lot, not to an engineer's laptop
- Safety-related traveler carries CMTR + heat + lot without transcription
- NRC inspector requests get answered from the system, not from the vault
- Prime contractors accept your QA program without a bespoke assessment
Every framework a nuclear prime, NRC or DOE will ask about.
10 CFR 50 Appendix B
The eighteen criteria for safety-related activities at NRC-licensed facilities — mapped to platform controls with live evidence.
NQA-1 (2008/2009 + 2015/2017)
ASME NQA-1 Part I (18 requirements) and Part II subparts including 2.7 (software) and 2.14 (commercial-grade dedication) as native workflow.
10 CFR Part 21
Reporting of defects and non-compliance — evaluator assignment, 60-day evaluation clock, board notification, NRC director filing evidence.
ASME BPVC Section III & NCA-3800
Material Organisation and Quality System Certificate (QSC) evidence — CMTR retention, heat/lot traceability, N-stamp support.
DOE O 414.1D / DOE-STD-1189
DOE Quality Assurance order and safety design methodology — subcontract-level QA program acceptance.
10 CFR 830 Subpart A
DOE Nuclear Safety Management — QA program requirements for DOE contractors, evidenced through the same base.
Nuclear-grade quality software, answered.
What is nuclear manufacturing software?
It's the QMS/MES stack that lets a fabricator or supplier work on safety-related nuclear scope — reactor components, safety-related instrumentation, spent-fuel systems — under 10 CFR 50 Appendix B and NQA-1. It enforces design/procurement/process control, commercial-grade dedication, Part 21 reporting and full material traceability so an NRC inspector or NUPIC auditor can trace any decision back to the record that supports it.
Does V5 replace an NQA-1 QA program?
V5 IS the operating layer of your NQA-1 program. Your QA program document still exists (and points at V5), but the eighteen requirements are executed and evidenced inside the platform rather than in binders and spreadsheets. That's how audit prep collapses from months to weeks.
How does 10 CFR Part 21 evaluation work?
Any non-conformance or deviation is triaged against Part 21 reportability. A named evaluator is assigned, technical review is captured, the 60-day evaluation clock runs, and if reportable, the board-notification and NRC director-filing workflow produces the record that regulators expect to see.
Does V5 support commercial-grade dedication (CGD)?
Yes. EPRI NP-5652 / TR-3002002982 methods 1 through 4 are modeled. Critical characteristics, acceptance criteria and dedicating-entity verification are captured per lot and tied to the traveler and the installed serial — not stored as a standalone PDF.
Cloud or on-prem?
Both, but most nuclear customers choose V5 Ultimate On-Premises. Safety-related program data, ITAR-controlled reactor designs and export-controlled technology stay inside the customer's boundary. Cloud is used for corporate-side supplier management.
How long does implementation take?
For a safety-related fabricator or Grade-A supplier, expect 4–6 months to a triennially-auditable state: full App B / NQA-1 mapping, CGD workflow, Part 21 evaluation, CMTR capture and supplier program. Commercial-grade quality piggybacks on the same base at no extra cost.
Make an NRC or NUPIC audit boring — because everything the auditor asks for is already in the system, dated and signed.
Free trial. On-prem evaluation available. No sales gate.