Global manufacturing operations
Manufacturing compliance software
One place to see whether every product can be sold in every market you sell it in, and what is missing where it cannot. Obligations resolved per product and market, changes assessed against the portfolio, and the evidence held against the thing it proves.
- One obligation register per product and per market, instead of one per spreadsheet
- Regulatory changes assessed against the portfolio, not published as a digest
- Technical files, declarations and test reports held against the product they prove
- Readiness for a new market answered before the commercial decision, not after
See your portfolio against your markets
Your products, your target markets, what is outstanding. 30 minutes.
Before you send
Take the two-minute assessment first — five questions across the main parts of ISO 37301 — and we will open the call on your own score, markets and regimes instead of on the basics.
The arithmetic
Capabilities
What the platform holds
for a manufacturing operation
Obligation register
What applies to this product, in this market, right now — safety, EMC, radio, substances, energy, packaging, cybersecurity — with the status of each and the evidence behind it.
Multi-market operations
CE and UKCA, FCC and CPSC, EAC, CCC, KC, INMETRO, NOM and the rest. The same product carries a different obligation set in each, and the differences are the part that gets missed.
Change to action
A published rule becomes an applicability assessment, then a task on a named product with an owner and a date. The loop closes on the product record rather than in an inbox.
Portfolio scale
An obligation is answered once per product and again whenever the product or the rule changes. At two hundred SKUs across nine markets, that arithmetic is the whole problem.
Built for physical products
Not a GRC tool adapted from IT controls. The data model is products, components, substances, markets and declarations, because that is what a manufacturer has.
Market readiness
Before entering a market, what would it take: which tests, which documents, which approvals, how long. Answered from the data you already hold rather than from a consultancy engagement.
FAQ
Manufacturing compliance, answered
- What is manufacturing compliance software?
- Manufacturing compliance software tracks whether the products a company makes meet the regulatory requirements of the markets it sells them in, and holds the evidence that proves it. For a manufacturer that means product safety standards, substance restrictions, EMC and radio approvals, energy and ecodesign rules, packaging and extended producer responsibility, and increasingly cybersecurity — per product, per market. It is a different category from quality management software, which governs how the product is made, and from IT GRC software, which governs security controls.
- What should compliance tracking software do for a global manufacturing operation?
- Three things. Keep a current register of what applies to each product in each market. Detect when any of that changes and say which products are affected, rather than publishing a feed. Hold the evidence — technical files, declarations, test reports, certificates — against the product it belongs to, with its expiry. Anything that does the first without the second degrades within a quarter; anything that does the first two without the third leaves you unable to prove it.
- How is this different from a QMS or an ERP?
- A QMS governs how you design and manufacture: processes, controls, non-conformities, ISO 9001. An ERP runs the business transactions. Neither holds the regulatory picture — which rules apply where, what changed, what evidence exists and whether it is current. Certean sits alongside both and integrates with the PLM and ERP where the product data already lives, rather than asking you to keep a second copy of it.
- Does it work for a manufacturer with a mixed catalogue?
- That is the normal case. A connected product, the bracket it mounts on, and a spare part are three different obligation sets, and treating the catalogue as if it were all the hardest item is how teams end up doing work nothing required. Obligations are resolved per product from its own data, so a simple item stays simple.
- How long does it take to see a portfolio in the platform?
- Weeks rather than months, because the product data usually exists already — in a PLM, an ERP, or a set of spreadsheets that have been maintained carefully. What takes the time is agreeing the market list and the product categories; once those are set, the obligation register is generated rather than typed.
Narrower questions have their own pages: material compliance, regulatory change monitoring, supplier declarations and US requirements.
Get started
Thirty minutes on your own catalogue
Bring a handful of products and the markets you sell them in. We will show you the register they generate.
See where you stand