State Of Control
Every regulated company says it wants a state of control. It writes the phrase into procedures, invokes it in front of inspectors, and builds careers around achieving it. Almost none have ever had one.
What the life sciences industry has had instead is a photograph of control: captured at intervals, signed, and filed as though the photograph were the thing, while the system it described kept moving. For two decades this was unavoidable, because after-the-fact manual capture was the only way to record that a system was under control. That constraint no longer holds, and almost no one has noticed.
In State of Control, Michael Martone makes the case that the burden weighing down validation in life sciences was never documentation itself, but the manual, delayed way the industry produces it, and that a genuine, continuous state of control is now achievable. Drawing on his work leading industry guidance for AI in regulated environments, Martone reframes qualification as a state to be demonstrated continuously rather than a document to be signed once, and shows how modern engineering practice and correctly-governed AI make it buildable today.
This is not a call to do less. It is an argument that rigor rises, accountability stays exactly where it belongs, and human judgment becomes more important, not less, when evidence becomes continuous. Clear-eyed, provocative, and practical, State of Control is for the quality professionals, engineers, and leaders ready to stop defending a frozen past and build the end state the industry always claimed to have.
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