SOP Management Software
SOPs are the backbone of a GMP quality system. They are also the number-one source of "current version" confusion during inspections. cGen manages SOPs the same way it manages validation records — controlled, signed, versioned, and trained.
Author → Reviewer → Approver → Trained-and-effective. Every stage produces a signed, timestamped record.
Reading an SOP is only compliance if the training is recorded. cGen binds training records to the specific SOP version and refreshes them on revision.
Every SOP has a review schedule. cGen surfaces the queue, tracks the reviewers, and archives the sign-off.
An SOP is a controlled document, and a GxP inspector will treat it as such. That means version control, controlled distribution, trained-and-effective status per user, periodic review, superseded-version retention, and controlled retirement — all with Part 11 electronic signatures and audit trail.
For most life-sciences companies, SOP management lives in one of three places: a document management system (usually a legacy tool with a compliance skin), an eQMS module, or a set of network folders and email. The last is indefensible; the first two are usually adequate for the SOP itself but silo the training records elsewhere, which is the audit failure mode.
How cGen fits
cGen handles SOPs as first-class controlled records. Every user's trained-and-effective status is bound to the specific SOP version they trained on. When the SOP is revised, the training is refreshed automatically — the same workflow that governs URS revisions in validation projects.
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