Documents, dates and proof
Compliance evidence management software
Compliance is not what you know, it is what you can show. Certean holds the technical files, declarations, test reports and certificates against the product and the obligation each one discharges — and tells you which of them stopped being good enough when the rule behind them moved.
- Every document attached to the product and the obligation it discharges
- Dated against the version of the rule it answered, not just the day it was filed
- Expiry and staleness surfaced before an auditor or a customer finds them
- A past state reconstructable: what applied then, and what you held to show it
See what your evidence covers
One product, the documents you hold, and the gaps between them. 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.
Three ways evidence fails
What is held
The evidence a product
has to carry
Technical files
The CE technical file and its equivalents: product description, drawings, risk assessment, the standards applied, test reports, and the declaration that rests on all of it. Assembled from the record rather than rebuilt per audit.
Declarations and certificates
Declarations of conformity, supplier statements, notified body certificates, FCC authorisations, CPSC certificates. Each with its scope, its issuer, its basis and its validity period.
Test reports
The report, the laboratory, the standard and its edition, and the sample it was run on. When a standard is revised, the reports that cite the superseded edition are the ones to find first.
Expiry and staleness
Two different problems. A certificate expires on a date you can diary. Evidence goes stale silently when the rule behind it moves, and that is the one that surfaces during an audit.
Point-in-time answers
An auditor asking why a product was compliant in March wants March’s rules and March’s evidence. Versioned obligations and dated evidence make that a query rather than an archaeology project.
Risk prioritisation
Not every gap is equal. Exposure is scored from the market, the volume, the regime and the age of the evidence, so a team of three works the list in the order that matters.
FAQ
Evidence management, answered
- What is compliance evidence management software?
- Software that holds the documents proving a product meets the requirements of the markets it is sold in — technical files, declarations of conformity, test reports, certificates, supplier declarations — and links each one to the product and the specific obligation it discharges. The distinguishing feature against a document management system is that it knows what each document is for: which rule, which market, which product, and until when.
- What should evidence management do that a shared drive does not?
- Three things. Tell you what is missing, by comparing the evidence held against the obligations that apply. Tell you what has expired, by holding validity periods rather than filenames. Tell you what has gone stale, by watching the rules each document depends on and flagging the ones whose basis has been revised. A shared drive can answer none of those without a person reading every file.
- How do you prove compliance for a date in the past?
- By versioning both sides. The obligations that applied to a product are kept as they stood on each date, and every piece of evidence is held with the date and the rule version it answered. Reconstructing March means querying both as of March. Without that, an audit of a past shipment is answered with today’s picture, which is not the question that was asked.
- How do product compliance teams prioritise which gaps to close first?
- By exposure rather than by the order the gaps were found. The inputs are the market the product is sold in and the enforcement there, the volume shipped, the regime involved and what the penalty for a failure actually is, and how old the supporting evidence is. Certean scores gaps on those and presents a ranked list, which matters most for small teams carrying large catalogues.
- Does this replace a document management system or a QMS?
- No. A DMS stores files and a QMS governs how the product is made. This governs the relationship between a requirement and the proof of it: which obligation, which product, which market, which document, valid until when, superseded by what. It integrates with the systems that already hold the files rather than asking you to move them.
What makes evidence go stale is covered on the regulatory change monitoring page, and where most of it comes from is your suppliers.
Get started
Find the gap before the auditor does
Bring one product and the documents behind it. Thirty minutes.
See where you stand