This process standard is not intended to incorporate every company specific requirement and does not dictate specific organizational structures within a company. This process standard does not specify a design or an implementation. Actual implementations may distribute responsibilities or break out functionality differently.
This document assumes that all requirements for configuration management of the type design data as specified by CFR Title 14, Part 21 [CFR 21] are in place and therefore are not specifically described in this document.
This document sets forth the minimum requirements for product data storage. If an organization chooses to implement requirements beyond those outlined in this standard, those additional requirements shall not conflict or negatively impact the standard requirements. Additional requirements shall also be documented for auditing purposes.