21 CFR Part 11
Ability to apply 21 CFR Part 11 practices and professional judgment to deliver reliable outcomes in quality & regulatory contexts.
What each level means
The P1–P5 scale is shared across every skill, but what each level means changes with the skill. This is what it looks like in practice.
P1
Describes the process, controls, stakeholders and basic decisions involved in 21 CFR Part 11.
P2
Executes standard 21 CFR Part 11 activities accurately within established controls and escalates exceptions.
P3
Owns complex 21 CFR Part 11 cases/processes, improves controls and coaches colleagues.
P4
Sets cross-team standards and governance for 21 CFR Part 11, integrating risk, metrics and stakeholder needs.
P5
Defines enterprise strategy or external practice for 21 CFR Part 11 and develops other experts.
Source: PROCOMER FTZ employer benchmark