Forms are the most basic record-creating instrument in a quality management system. A non-conformance report, a training completion record, a supplier qualification checklist, a corrective action plan, a product inspection sheet: each is a structured form that a person fills in, signs, and submits. The resulting record must remain accurate and retrievable for the lifetime of the device, and in some cases well beyond it.
Regulated environments add requirements on top of the basic concept. FDA 21 CFR Part 11 governs electronic records and electronic signatures: forms completed in a software system must be attributable to a specific person, timestamped, and protected from alteration after submission. Approved changes to a closed record must be traceable, showing what was changed, by whom, when, and why. ISO 13485:2016 Clause 4.2.4 requires that records remain legible, identifiable, and retrievable throughout the required retention period.
Form types vary by purpose. General forms collect structured data in a free or guided layout. Task-based forms sequence steps that must be completed in order, with each step acknowledged before the next opens. Matrix forms organise data in rows and columns for structured comparison, risk scoring, or traceability mapping.
Version control of the form itself is a separate concern from the records it produces. Updating a form template applies only to future completions: records made under the previous version remain under that version.
The whitepaper below shows how qmsWrapper handles forms for medical device quality teams.
