Decision support, not a change approval. Only your quality unit approves a change, under your own change-control SOP, and its thresholds will differ from these. Every point and every rule is shown so the rubric can be argued with — and it names no variation category and quotes no regulatory clock, because those belong to your regulatory function and jurisdiction. Nothing you enter is uploaded.
Planned change ·
How big is this change, really?
Before a planned change is made, someone has to size it — and the expensive mistake runs in one direction: a change called "like-for-like" that turns out to have moved a validated process, found months later by someone who is not you. Answer 8 questions and get a minor/moderate/major impact tier, the approvals it needs, the revalidation it triggers, the 8 hard floors that override the raw score, and the answers that contradict each other. Free.
8factors, all disclosed
8hard floors a score can't average away
3routes, each with its own evidence
0bytes transmitted
Assess the planned change
Answer for the change as proposed, not as you hope it will be scoped after review. "Like-for-like" is an input to be tested here, never a conclusion — which is the whole reason the assessment runs before the revalidation decision rather than after it.
Pricing
Unlimited assessment is free and stays free. The Change Control Kit is what the rubric deliberately does not do: it tells you how to write the assessment and run the revalidation the tier just called for.
Free
$0
All 8 factors, with every point shown
All 8 hard floors, each naming why it fired
The impact tier with its approvals and revalidation scope
Triggered actions and contradiction checks
100% client-side, nothing transmitted
Change Control Kit
$99 one-time
Impact assessment skeleton — the 8 sections a defensible assessment carries, including the one inspectors read first
Revalidation depth by tier — what evidence each route actually needs, and what it does not
The six "like-for-like" traps — the specific claims that are almost never like-for-like, and why
Inspector questions — what gets asked about change control, and what a good answer looks like
Effectiveness checks that work — choosing a criterion and a window before the data exists