164.316(b)(2)(ii) Availability (Documentation)
Policies and Procedures safeguard · Provision
The requirement as we hold it
Availability (Documentation). Make documentation available to those persons responsible for implementing the procedures to which the documentation pertains.
The examiner asks
- Show me that the documentation is available to the people responsible for implementing it.
- How do they reach it?
Evidence to bring
- the document access path
- the distribution record
Source: 164.316(b)(2)(ii) at eCFR. Our statement of the clause, not the instrument verbatim.