Regulatory Hub

The records retention module enforces GxP-required data lifecycle policies. Each category of record is governed by a minimum retention period derived from applicable regulations. Automated archival workflows trigger at end-of-life, with mandatory legal hold exception handling.

Rule ID	Record Category	Min Retention	Regulatory Basis	Record Count	Status
RR-001	Clinical Trial Records	25 years	ICH E6(R3), 21 CFR 312.62	12,450	Active
RR-002	Regulatory Submissions	15 years	21 CFR 314.81, EMA/CHMP	8,920	Active
RR-003	Manufacturing Records	10 years	21 CFR 211.196, EU GMP Annex 11	45,000	Active
RR-004	Pharmacovigilance Records	10 years	GVP Module VI, ICH E2E	6,700	Active
RR-005	Audit Trail Records	5 years	21 CFR Part 11, EU Annex 11	25,000	Active
RR-006	Validation Documentation	5 years	GAMP 5, 21 CFR Part 11	3,200	Active
RR-007	SOPs and Policies	3 years	ISO 9001, GxP general	890	Active
RR-008	Correspondence with Authorities	15 years	21 CFR 314.81, EMA operational	2,300	Active
RR-009	Stability Data	Life+5y	ICH Q1A, 21 CFR 211.166	18,900	Active
RR-010	Labeling Artefacts	10 years	EU Reg 2016/161, FDA labeling	1,450	Active

Upcoming Archival Events

3 record batches are scheduled for archival in the next 90 days. Legal hold review required for 1 batch (Litigation Hold LH-2024-003 active).

Records Retention