PracticeForceOne™ Healthcare Quality & Safety Consortium
Master Clinical Governance & Regulatory Omnibus Attestation
Covering FDA 21 CFR Part 11, FDA DSCSA GS1-128, USP <797> BUD, State Medical Board GFE & ONC § 170.315(b)(10) EHI Export
100% VALIDATED PASS
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32 / 32 Clinical Assertions Verified
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CERT-OMNIBUS-CLINICAL-208479B4F2BF
21 CFR 11 PASS
FDA 21 CFR Part 11 Electronic Records & Electronic Signatures
FDA 21 CFR Part 11 (Electronic Records, Tamper-Evident Signatures & Immutable Audit Trails)
CERT-FDA-21CFR11-2FB064978FB1
100.0% PASS
DSCSA VERIFIED
FDA Drug Supply Chain Security Act (DSCSA) & GS1-128 Serialization
FDA DSCSA & GS1-128 (GTIN, Lot Serialization, 2D DataMatrix & Chain-of-Custody)
CERT-FDA-DSCSA-E1F3F99B19D8
100.0% PASS
USP 797 CONFORMANT
USP <797> / <800> Reconstituted Biologics & Beyond-Use Dating (BUD)
USP <797> / <800> Compounded Sterile Preparations & Reconstitution Timers
CERT-USP-797-B463441EB06F
100.0% PASS
GFE GATE PASS
Good Faith Exam (GFE) & Physician Supervisory Delegation Standards
State Medical Board Good Faith Exam (GFE) & MD/DO Delegation (Rule 18 / MEDSPA-AES-035)
CERT-MEDBOARD-GFE-BF5271AA7CD9
100.0% PASS
EHI EXPORT PASS
ONC § 170.315(b)(10) Electronic Health Information (EHI) Export
ONC § 170.315(b)(10) Single & Population EHI Export & Anti-Information Blocking (45 CFR § 171)
CERT-ONC-EHI-EFA124A9D415
100.0% PASS
Omnibus SHA-256 Composite Digest:
208479b4f2bf76aa8221cd6cae2af00e6fa3194a3812037d32ac13ed34b60b84