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The current procedure is findable, and the control is enforced
A regulated quality system usually runs on a folder tree of Word files, with a lifecycle people are trusted to follow. We move it into a database and enforce the lifecycle in software, so the current procedure is the one you find and the trail behind it is a real record.
A folder tree cannot enforce a lifecycle
A regulated quality system usually lives as a folder tree of Word files on a shared drive. The current revision, its signatures, and the record of who has read it sit in different places, so finding the current procedure means knowing where someone filed it.
The lifecycle itself is a convention. Draft, review, approve, effective: a sequence people are trusted to follow. In an audit, you are trusting that the convention held every time.
Control moves into a database and the lifecycle is enforced
We move the quality system into a database and enforce the lifecycle in software: draft, in-review, approved, effective, signed with re-authentication. An unsigned draft cannot become effective, and no one approves their own work.
Every document carries its own attributes, so you filter and search for the current procedure instead of hunting for it. The revision you find is the effective one.
Every revision and signature is a real record
Every revision, signature, and approval is a record in the system, produced as the document moves through its lifecycle. Nothing is reconstructed from folders and email the week before an audit.
When an auditor asks who approved what, and when, the answer is a query against the record, not a search of the shared drive.
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Start with your most controlled document
Tell us how your quality documents move today and we will scope the lifecycle. Email hello@mcintoshsystems.com.