Evidence in context
Evidence & Records
ARQEN helps teams assemble review packets without separating the output from the records, evidence, decisions, and people that produced it. The result is easier to inspect, revise, and return to its source.
How it supports the quality loop
Module-linked packets
Bring the owning quality record, product context, review history, required fields, and evidence references into one reviewable packet.
Reusable templates
Shape repeatable packet structures for inspection planning, FAIR preparation, NCR/CAPA, Management Review, supplier quality, and audit follow-up.
Readiness checks
Make missing fields, evidence gaps, open actions, ownership, and review requirements visible before a packet is used.
Source drillback
Return from the packet to the exact record, product, workflow, or evidence reference that supports the statement.
Assisted drafting
Prepare editable language from source context while keeping the reviewer responsible for accuracy, purpose, approval, and release.
Human review point
An accountable reviewer confirms the packet purpose, source identity, revision, evidence fitness, required approvals, distribution, and any certification or customer-specific use.