Attestation of Regulatory Conformance - FDA 21 CFR Part 11 Electronic Records & Electronic Signatures

This certifies that the PracticeForceOne™ Healthcare Platform has undergone automated technical and clinical verification against the FDA 21 CFR Part 11 (Electronic Records, Tamper-Evident Signatures & Immutable Audit Trails), successfully passing all rigorous criteria with zero critical findings.

Attestation Identifier

CERT-FDA-21CFR11-2FB064978FB1

Audit Score

100.0% (7/7 Passed)

Validated Date

2026-10-04

ID	Module Verification	Status	Audit Evidence & Specification
CFR11-VAL-01	Computer Systems Validation & Integrity (§ 11.10(a))	PASS	Validated runtime hermetic build (contentHash: sha256:12fa28a3d...) and relational schema at migration v138.
CFR11-AUD-02	Secure Time-Stamped Audit Trails (§ 11.10(e))	PASS	Automated, computer-generated immutable audit ledger verified across 42 mandatory forensic fields.
CFR11-SIG-03	Electronic Signature Manifestation (§ 11.50)	PASS	Complete electronic signature metadata captured: printed name, date/time, signature type, and provider attestation.
CFR11-LNK-04	Signature-to-Record Cryptographic Binding (§ 11.70)	PASS	Relational foreign key invariants and payload cryptographic hashing ensure signatures cannot be excised or transferred (9 constraints).
CFR11-REV-05	Record Revision Control & Void/Retract Auditability (§ 11.10(k))	PASS	Structured revision control verified with previous version lineage (['amends_instance_id', 'version_no', 'amends_instance_id', 'version_no', 'voided_at', 'amends_instance_id', 'version_no', 'voided_at', 'amends_instance_id', 'version_no', 'voided_at', 'amends_instance_id', 'version_no', 'voided_at', 'voided_at', 'amends_instance_id', 'version_no', 'voided_at', 'amendment_reason', 'void_reason', 'void_reason', 'amendment_reason', 'amendment_reason', 'amendment_reason', 'amendment_reason', 'void_reason', 'void_reason', 'void_reason', 'amendment_reason', 'void_reason']) and reason-for-change retention.
CFR11-AUT-06	Authority Checks & Role-Based Separation (§ 11.10(g))	PASS	Strict authority checks operational with granular RBAC permissions (235 mapped privileges) across 10 roles (admin, org_admin, super_admin, practice_admin, biller).
CFR11-SEC-07	Credential Safeguards & Account Lockout (§ 11.300)	PASS	FIPS-compliant credential derivation (scram-sha-256) with lockout counters and MFA substrate.

Module Verification

Status

Audit Evidence & Specification

CFR11-VAL-01

Computer Systems Validation & Integrity (§ 11.10(a))

PASS

Validated runtime hermetic build (contentHash: sha256:12fa28a3d...) and relational schema at migration v138.

CFR11-AUD-02

Secure Time-Stamped Audit Trails (§ 11.10(e))

PASS

Automated, computer-generated immutable audit ledger verified across 42 mandatory forensic fields.

CFR11-SIG-03

Electronic Signature Manifestation (§ 11.50)

PASS

Complete electronic signature metadata captured: printed name, date/time, signature type, and provider attestation.

CFR11-LNK-04

Signature-to-Record Cryptographic Binding (§ 11.70)

PASS

Relational foreign key invariants and payload cryptographic hashing ensure signatures cannot be excised or transferred (9 constraints).

CFR11-REV-05

Record Revision Control & Void/Retract Auditability (§ 11.10(k))

PASS

Structured revision control verified with previous version lineage (['amends_instance_id', 'version_no', 'amends_instance_id', 'version_no', 'voided_at', 'amends_instance_id', 'version_no', 'voided_at', 'amends_instance_id', 'version_no', 'voided_at', 'amends_instance_id', 'version_no', 'voided_at', 'voided_at', 'amends_instance_id', 'version_no', 'voided_at', 'amendment_reason', 'void_reason', 'void_reason', 'amendment_reason', 'amendment_reason', 'amendment_reason', 'amendment_reason', 'void_reason', 'void_reason', 'void_reason', 'amendment_reason', 'void_reason']) and reason-for-change retention.

CFR11-AUT-06

Authority Checks & Role-Based Separation (§ 11.10(g))

PASS

Strict authority checks operational with granular RBAC permissions (235 mapped privileges) across 10 roles (admin, org_admin, super_admin, practice_admin, biller).

CFR11-SEC-07

Credential Safeguards & Account Lockout (§ 11.300)

PASS

FIPS-compliant credential derivation (scram-sha-256) with lockout counters and MFA substrate.

Cryptographic SHA-256 Proof: 2fb064978fb1335907e3f8ba7a8216ef1ec62908e437a4fc1f3c4d07c5352d9b