Baseline Regulatory Completeness Certification

Sawgrass Nutra Labs — Quality Management System

1. Purpose

This record documents the completion of a one-time baseline regulatory completeness audit conducted to establish the initial compliance state of the Sawgrass Nutra Labs Quality Management System (QMS).

The audit evaluated the L0-REG Regulatory Crosswalk as the primary system-of-record for regulatory interpretation and SOP mapping.

Clarification of Audit Focus:
The Master Hierarchy Navigator v9 was not audited for procedural content or quality. It was used exclusively to define and validate the authorized SOP universe against which regulatory coverage in L0-REG was assessed.

2. Baseline Scope

Regulatory Scope:

21 CFR Part 111
21 CFR Part 11 (as applicable)
NSF/ANSI 455-2
Dry-processing dietary supplement operations

Authorized SOP Universe Reference:

Family Pack 0 — Master Hierarchy Navigator v9

3. Audit Method

A system-level completeness audit was conducted by reviewing each applicable regulatory requirement documented in L0-REG to verify that it is mapped to one or more SOPs contained in the authorized SOP universe.

Completeness was evaluated using the following binary test:

COUNT(applicable regulatory requirements)
=
COUNT(requirements with ≥1 mapped SOP)

4. Audit Results

All applicable regulatory requirements are mapped to one or more SOPs
No unmapped (orphan) regulatory requirements were identified
No SOPs outside the authorized hierarchy were referenced
Regulatory interpretation is centralized exclusively in L0-REG

Audit Outcome:
Baseline regulatory-to-SOP completeness has been successfully established with no identified gaps.

5. Baseline Certification and Freeze

As of the effective date of this record, Sawgrass Nutra Labs formally certifies that:

L0-REG is the authoritative and complete system-of-record for regulatory requirements and SOP mapping
Master Hierarchy Navigator v9 represents the complete and authorized SOP universe reference
Regulatory completeness is hereby established as a controlled baseline

All future changes impacting regulatory requirements or SOP coverage are governed exclusively through formal Change Control.

6. Record Status

Status: Baseline Established — Frozen
Change Control: Not applicable (historical establishment record)
Retention: System lifetime

This record serves as Quality System Establishment evidence. It documents the establishment of regulatory completeness and does not constitute operational or execution evidence.