Qualitum reads the standard or regulation, breaks it into auditable clauses and matches each one to the procedures, records and test results you already hold. Gaps are listed with what the auditor would ask. Your team decides what to fix.
Certification audits test whether every clause has a procedure and a record behind it. Finding that out by hand takes weeks.
Hundreds of clauses, each with its own expectation.
Procedures, records and reports across systems and sites.
The clause matrix from the last audit no longer matches reality.
Non-conformities found by the auditor, not by you.
Qualitum keeps the chain intact - as data, not documents.
What the engine reads, links and drafts. Every item keeps a link to the requirement it answers.
Coverage is measured against the clause, not against a template.
Quality and compliance teams preparing for certification and surveillance audits.
Engineering and regulatory teams producing conformity documentation.
Same engine that runs pharma validation, applied to certification.
The standard plus your procedures, records and reports.
Every clause becomes an auditable requirement.
Each clause linked to its evidence, or flagged as a gap.
Your quality team confirms. The audit pack is ready.
We map the standard’s clauses to the procedures you sent and list what is covered, partial or missing.
Our reference deployment is in pharmaceutical validation. Screens on this page show illustrative examples, not customer data.
Any standard or regulation you can provide as text. Common ones include ISO 9001, ISO 13485, AS9100, ISO 27001 and EU product regulations.
No. It prepares your evidence. The certification body still audits, and your team still signs.
No. Agents draft and check. Your qualified people review, approve and sign every output.
In a single-tenant deployment inside your environment, with your choice of model, EU, US or UAE residency and air-gap capability. No training on your data.