Predetermined Change Control Plan
Also known as: PCCP
A regulatory mechanism through which a manufacturer of a regulated software product describes, in advance, the modifications it intends to make and how it will validate them.
A Predetermined Change Control Plan addresses a structural problem with regulating machine learning software: a model that is expected to be updated does not fit a framework built around a fixed, unchanging device. A PCCP lets a manufacturer specify in advance the changes it plans to make, the methods used to develop and validate them, and the assessment of their impact.
The concept matters to buyers because it bears directly on what happens when the product they evaluated is no longer quite the product they are running.
This entry describes a regulatory concept. It does not assert that any particular product has, or does not have, an authorized change control plan or any other regulatory status. Regulatory status for a specific product must be verified against the relevant regulatory record, not inferred from a vendor’s description or from this entry.
The buyer-side question is simpler than the regulatory machinery: when this vendor updates the model, how will we be told, and what do we have to revalidate.