/**
 * 21 CFR Part 11 Compliance Pack
 *
 * FDA Electronic Records and Electronic Signatures (1997), under:
 *   - FDA 2003 Scope & Application Guidance (risk-based enforcement)
 *   - EU Annex 11 (GMP equivalent for computerised systems)
 *   - FDA 2024 GenAI guidance for clinical records (AI provenance)
 *
 * Applies when AI agents create, modify, maintain, archive, retrieve,
 * or transmit records required by an FDA predicate rule (21 CFR Part
 * 211 GMP, Part 58 GLP, Part 312 IND, Part 314 NDA, Part 820 QSR).
 *
 * ALCOA+ data integrity principles: Attributable, Legible,
 * Contemporaneous, Original, Accurate + Complete, Consistent,
 * Enduring, Available.
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * 21 CFR Part 11 (FDA Electronic Records / Electronic Signatures) category classifiers.
 * Part 11 governs process flows: validation (IQ/OQ/PQ), e-signature, audit trail,
 * and ALCOA+ for regulated electronic records. Classification targets regulated records,
 * PHI in clinical systems, PII, credentials, and AI-generated content in GxP systems.
 */
export declare const PART11_CATEGORY_CLASSIFIERS: CategoryClassifiers;
export declare const PART11_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
};
//# sourceMappingURL=part11.d.ts.map